Quality Auditor - Medical Device Job at SQA Services (Minneapolis-St. Paul, MN)

Quality Auditor - Pharmaceutical

This is a contract opportunity in which you will perform supplier quality audits...

Location

United States , Milwaukee, WI / Algoma, WI / Janesville, WI / Madison, WI / Neenah, WI / Shawano, WI

Salary:

Not provided

SQA Services

Expiration Date

Until further notice

Requirements

5+ years of hands-on audit experience in pharmaceutical, medical device, and/or biologics industries
Has been the lead auditor in at least 10 audits
Direct audit experience to 21 CFR part 210/211 and ISO 9001
Strong communication and writing skills
Proven ability to deescalate workplace conflicts effectively
Ability to adapt to new technology and software
Willingness to travel regionally

Job Responsibility

Perform supplier audits at various sites within your region of residence
Assure quality in the supply chains of various clients within the pharmaceutical, medical device, cosmetics, biologics, and/or animal health industries
Coordinate, prepare, execute, and deliver supplier audits based on your own and the client schedule
Utilize your regulatory knowledge of various standards from ISO, CFR, FDA, etc
Respond to the Content team in a timely manner regarding edits/questions to your audit report
Write audit reports in accordance with client specifications

What we offer

Flexibility to accept or reject assignments according to your own availability
Travel expenses are reimbursed at cost with receipts per SQA travel policy

Supplier Quality Manager

We are looking for a driven, creative and experienced: Supplier Quality Manager

Location

Czech Republic , Veverska Bityska

Salary:

Not provided

HARTMANN

Expiration Date

Until further notice

Requirements

Technical university education
Experience in conducting of external supplier audits in the medical device industry
Qualification as lead auditor for ISO 9001, ideally ISO 13485
Experience with working in the area of medical devices acc. MDR and FDA
Willingness and desire to work and communicate in an international environment across the company
Willingness to travel internationally
Business Proficiency English
One or several of the following languages would be beneficial: German, French, Spanish, Turkish or Arabic
Independence, diligence, precision
Systematicity and technical thinking preferable production experience

Job Responsibility

Conducting supplier quality audits at Suppliers to ensure independently the compliance of HARTMANN
Support the technical development of the suppliers and provide them with ad-hoc support
Maintain all SQM-activities related to product and supply quality for assigned product portfolios and projects
Applying the requirements of reliable regulations and standards (eg. ISO 9001, ISO 13485, MDR, FDA) at suppliers
Supervision of the implementation of corrective measures
Evaluating the effectiveness of implemented actions by supplier
Communication across the entire global company with the relevant international stakeholders

What we offer

Interesting and responsible work in a prosperous company
Working with in an international team and environment
Working internationally
Long-term stable work
Possibility of individual development and education
25 days of vacation
Benefit card
Annual bonus after meeting the conditions
Contribution to company catering
Contribution to pension insurance

Fulltime

New

Sr. Compliance Quality Engineer

This is where you make a difference in our patients’ safety. As a member of the ...

Location

Costa Rica , Cartago

Salary:

Not provided

Baxter

Expiration Date

Until further notice

Requirements

Minimum of 4 years of experience in manufacturing processes, quality systems, regulatory compliance, and GMPs within Baxter or in companies producing healthcare devices
Validated knowledge of ISO 9001, ISO 13485, PMD Law, CMDR, MDSAP, CFR 21 and the Manufacturing Maturity Program (CMMI)
Validated experience in auditing systems and certification as an Internal Auditor
Knowledge and experience in Sterility Assurance
University training in Engineering (Production, Industrial, Chemical, Systems, Electrical, Electronics, Electromechanics) or related career
Equivalent experience in production environments with Quality Systems in the medical device manufacturing industry

Job Responsibility

Own the Complaints, CAPA, Risk Management, Hold and Corrective Actions systems, as well as their critical metrics and participation in local, regional and corporate forums
Implement the Internal Audit Program and follow up on corrective and preventive actions
Assess the regulatory alignment of processes and systems
Ensure they follow applicable directives and standards
Coordinate the system for change oversight, making sure changes stay in sync with regulatory requirements
Ensure evaluations of complaint samples, manufacturing investigations, and coordination with Product Surveillance within defined timeframes
Facilitate root cause analysis and ensure complete documentation in CAPA processes
Implement and maintain the risk system, assessing and controlling risks and leading residual risk
Ensure the accurate execution of the Hold process and the corrective field actions (FCA)
Maintain effective communication with productive areas and lead actions to reduce complaints

What we offer

Support for Parents
Continuing Education/ Professional Development
Employee Heath & Well-Being Benefits
Paid Time Off
2 Days a Year to Volunteer

Fulltime

Quality Associate II

This is where you make a difference in our patients’ safety. As a member of the ...

Location

United States , Round Lake

Salary:

88000.00 - 121000.00 USD / Year

Baxter

Expiration Date

Until further notice

Requirements

BS in business/science or equivalent degree
3 or more years of experience in Quality with a pharmaceutical or medical device company, or other similarly regulated industry
Previous auditing experience required, and ASQ and/or other accreditation is highly desirable
Strong interpersonal skills and great attention to detail are necessary
Must be a team player with good problem solving, and good verbal and written communication skills
Must be able to handle multiple projects concurrently
Computer skills/experience using MS Office, TrackWise, Cornerstone, or similar systems is highly desirable
Must have knowledge of and experience with FDA Regulations, Application of Good Laboratory Practices, and Application of Good Manufacturing Practices
Knowledge of and experience with outside the US regulatory requirements is desirable
A candidate must not be allergic to Penicillin and Cephalosporin or their related products and /or materials

Job Responsibility

Schedules, plans, and coordinates compliance audits and quality systems assessments ensuring compliance with corporate and regulatory provisions of the Quality System
Conducts internal audits and compliance gap analysis using the applicable quality manuals, global and/or local procedures, applicable country regulations, directives, standards, inspection guidelines and compendia as requirements
Supports management during external inspections and participates in the preparation, coordination, and management of external inspections as required
Schedules and coordinates Management Review and Quality Data Review meetings, including publishing of summaries of the data presented, conclusions, and meeting minutes
Prepares and publishes annual product reviews
Primary responsibility for the execution and management of the internal audit process at Round Lake Drug Delivery ensuring compliance with all applicable provisions of Baxter’s Quality System, and the regulations and standards applicable to RLDD operations
Schedules and plans for the audit activity by researching background information, including previous audit results
Plans and develops assessment strategy and logistics
Performs internal audits, either individually or as a team lead/participant, by collecting and analyzing objective evidence regarding issues and risks
Reports findings (verbally and written) to management

What we offer

Support for Parents
Continuing Education/ Professional Development
Employee Heath & Well-Being Benefits
Paid Time Off
2 Days a Year to Volunteer
Medical and dental coverage that start on day one
Insurance coverage for basic life, accident, short-term and long-term disability, and business travel accident insurance
Employee Stock Purchase Plan (ESPP), with the ability to purchase company stock at a discount
401(k) Retirement Savings Plan (RSP), with options for employee contributions and company matching
Flexible Spending Accounts

Fulltime

Quality Associate II

This is where you make a difference in our patients’ safety. As a member of the ...

Location

United States , Round Lake

Salary:

88000.00 - 121000.00 USD / Year

Baxter

Expiration Date

Until further notice

Requirements

BS in business/science or equivalent degree
3 or more years of experience in Quality with a pharmaceutical or medical device company, or other similarly regulated industry
Previous auditing experience required, and ASQ and/or other accreditation is highly desirable
Strong interpersonal skills and great attention to detail are necessary
Must be a team player with good problem solving, and good verbal and written communication skills
Must be able to handle multiple projects concurrently
Computer skills/experience using MS Office, TrackWise, Cornerstone, or similar systems is highly desirable
Must have knowledge of and experience with FDA Regulations, Application of Good Laboratory Practices, and Application of Good Manufacturing Practices
Knowledge of and experience with outside the US regulatory requirements is desirable
A candidate must not be allergic to Penicillin and Cephalosporin or their related products and /or materials

Job Responsibility

Schedules, plans, and coordinates compliance audits and quality systems assessments ensuring compliance with corporate and regulatory provisions of the Quality System
Conducts internal audits and compliance gap analysis using the applicable quality manuals, global and/or local procedures, applicable country regulations, directives, standards, inspection guidelines and compendia as requirements
Supports management during external inspections and participates in the preparation, coordination, and management of external inspections as required
Schedules and coordinates Management Review and Quality Data Review meetings, including publishing of summaries of the data presented, conclusions, and meeting minutes
Prepares and publishes annual product reviews
Primary responsibility for the execution and management of the internal audit process at Round Lake Drug Delivery ensuring compliance with all applicable provisions of Baxter’s Quality System, and the regulations and standards applicable to RLDD operations
Schedules and plans for the audit activity by researching background information, including previous audit results. Plans and develops assessment strategy and logistics
Performs internal audits, either individually or as a team lead/participant, by collecting and analyzing objective evidence regarding issues and risks. Reports findings (verbally and written) to management
Evaluates corrective and preventive action responses to the audit findings for adequacy, including root cause determination and timeliness. Escalates issues to management as appropriate. Tracks and reports on commitment status through closure
Manages the audit file through the entire process to closure. Prepares summary reports depicting results and trends for management review purposes

What we offer

Support for Parents
Continuing Education/ Professional Development
Employee Heath & Well-Being Benefits
Paid Time Off
2 Days a Year to Volunteer
Medical and dental coverage that start on day one
Basic life, accident, short-term and long-term disability, and business travel accident insurance
Employee Stock Purchase Plan (ESPP)
401(k) Retirement Savings Plan (RSP)
Flexible Spending Accounts

Fulltime

Quality Associate II

This is where you make a difference in our patients’ safety. As a member of the ...

Location

United States , Round Lake

Salary:

88000.00 - 121000.00 USD / Year

Baxter

Expiration Date

Until further notice

Requirements

BS in business/science or equivalent degree
3 or more years of experience in Quality with a pharmaceutical or medical device company, or other similarly regulated industry
Previous auditing experience required, and ASQ and/or other accreditation is highly desirable
Strong interpersonal skills and great attention to detail are necessary
Must be a team player with good problem solving, and good verbal and written communication skills
Must be able to handle multiple projects concurrently
Computer skills/experience using MS Office, TrackWise, Cornerstone, or similar systems is highly desirable
Must have knowledge of and experience with FDA Regulations, Application of Good Laboratory Practices, and Application of Good Manufacturing Practices
Knowledge of and experience with outside the US regulatory requirements is desirable
A candidate must not be allergic to Penicillin and Cephalosporin or their related products and /or materials

Job Responsibility

Primary responsibility for the execution and management of the internal audit process at Round Lake Drug Delivery ensuring compliance with all applicable provisions of Baxter’s Quality System, and the regulations and standards applicable to RLDD operations
Schedules and plans for the audit activity by researching background information, including previous audit results. Plans and develops assessment strategy and logistics
Performs internal audits, either individually or as a team lead/participant, by collecting and analyzing objective evidence regarding issues and risks. Reports findings (verbally and written) to management
Evaluates corrective and preventive action responses to the audit findings for adequacy, including root cause determination and timeliness. Escalates issues to management as appropriate. Tracks and reports on commitment status through closure
Manages the audit file through the entire process to closure. Prepares summary reports depicting results and trends for management review purposes
Performs follow-up audits, when applicable, to confirm corrective and preventive action is effective
Trains and mentors new auditors and manages the guest auditor program
Supports management of external inspections. Tracks and reports the status of external commitments through closure
Schedules and coordinates Management Review and Quality Data Review meetings, including publishing of summaries of the data presented, conclusions, and meeting minutes as required. Documents and tracks action items and follow-up commitments to closure
Leads and manages multiple projects/teams including corporate quality policy & procedure gap analysis and implementation, the global audit observation certification process, Annual Product Reviews, SOP and training code audits, and other quality system improvement projects

What we offer

Support for Parents
Continuing Education/ Professional Development
Employee Heath & Well-Being Benefits
Paid Time Off
2 Days a Year to Volunteer
medical and dental coverage that start on day one
insurance coverage for basic life, accident, short-term and long-term disability, and business travel accident insurance
Employee Stock Purchase Plan (ESPP), with the ability to purchase company stock at a discount
401(k) Retirement Savings Plan (RSP), with options for employee contributions and company matching
Flexible Spending Accounts

Fulltime

Quality associate II

This is where you make a difference in our patients’ safety. As a member of the ...

Location

United States , Round Lake

Salary:

88000.00 - 121000.00 USD / Year

Baxter

Expiration Date

Until further notice

Requirements

BS in business/science or equivalent degree
3 or more years of experience in Quality with a pharmaceutical or medical device company, or other similarly regulated industry
Previous auditing experience required, and ASQ and/or other accreditation is highly desirable
Strong interpersonal skills and great attention to detail are necessary
Must be a team player with good problem solving, and good verbal and written communication skills
Must be able to handle multiple projects concurrently
Computer skills/experience using MS Office, TrackWise, Cornerstone, or similar systems is highly desirable
Must have knowledge of and experience with FDA Regulations, Application of Good Laboratory Practices, and Application of Good Manufacturing Practices
A candidate must not be allergic to Penicillin and Cephalosporin or their related products and /or materials
Applicants must be authorized to work for any employer in the U.S. We are unable to sponsor or take over sponsorship of an employment visa at this time

Job Responsibility

Primary responsibility for the execution and management of the internal audit process at Round Lake Drug Delivery ensuring compliance with all applicable provisions of Baxter’s Quality System, and the regulations and standards applicable to RLDD operations
Schedules and plans for the audit activity by researching background information, including previous audit results. Plans and develops assessment strategy and logistics
Performs internal audits, either individually or as a team lead/participant, by collecting and analyzing objective evidence regarding issues and risks. Reports findings (verbally and written) to management
Evaluates corrective and preventive action responses to the audit findings for adequacy, including root cause determination and timeliness. Escalates issues to management as appropriate. Tracks and reports on commitment status through closure
Manages the audit file through the entire process to closure. Prepares summary reports depicting results and trends for management review purposes
Performs follow-up audits, when applicable, to confirm corrective and preventive action is effective
Trains and mentors new auditors and manages the guest auditor program
Supports management of external inspections. Tracks and reports the status of external commitments through closure
Schedules and coordinates Management Review and Quality Data Review meetings, including publishing of summaries of the data presented, conclusions, and meeting minutes as required. Documents and tracks action items and follow-up commitments to closure
Leads and manages multiple projects/teams including corporate quality policy & procedure gap analysis and implementation, the global audit observation certification process, Annual Product Reviews, SOP and training code audits, and other quality system improvement projects

What we offer

Support for Parents
Continuing Education/ Professional Development
Employee Heath & Well-Being Benefits
Paid Time Off
2 Days a Year to Volunteer
medical and dental coverage that start on day one
insurance coverage for basic life, accident, short-term and long-term disability, and business travel accident insurance
Employee Stock Purchase Plan (ESPP), with the ability to purchase company stock at a discount
401(k) Retirement Savings Plan (RSP), with options for employee contributions and company matching
Flexible Spending Accounts

Fulltime

Senior Supplier Quality Engineer

The Interventional Urology Sr. Supplier Quality Engineer will support our ongoin...

Location

United States , Minneapolis

Salary:

115876.00 - 173813.00 USD / Year

Coloplast

Expiration Date

Until further notice

Requirements

Bachelor's degree in a relevant science or engineering discipline
5+ year of related experience in supplier management
2+ years of experience in medical device manufacturing
Experience in medical device process and product validation, sampling, and statistics (e.g. DOE, process analysis/capability, Minitab, and repeatability and reproducibility) highly preferred
Able to travel up to 10%
Knowledge of FDA regulations (21 CFR Part 820) and ISO standards (13485, 14971) and their application
Ability to apply standard techniques, procedures, and criteria to perform assigned tasks
Exercises judgment on details of work and able to demonstrate knowledge and developing skills in the supplier quality function
Analytical problem-solving skills
Experience with continuous improvement, Lean six-sigma, or similar programs and techniques

Job Responsibility

Provide direct quality engineering support and strategic solutions to the supply chain to ensure quality compliance, FDA/ISO compliance and issue resolution
act as the supplier quality subject matter expert (SME) in appropriate projects
Manage the Supplier Quality Audit program
includes performing audits or coordinating an outside firm to perform the audits, maintain the Supplier Quality Audit schedule and audit-related records/documents
Act as internal interface/liaison and partner to Corporate Procurement
Active participation in Material Review Board meetings
Initiate and update Supplier Quality Agreements
Recommend and implement quality improvements of product and processes to promote continuous improvement at suppliers and contract manufacturers
Initiate supplier investigation requests and assist in root cause investigations for supplier related issues
Participate in product and process risk management activities

What we offer

Comprehensive medical, dental, and vision insurance plans
Access to company sponsored wellness programs and mental health resources
Paid leave of absence for qualifying events
Generous paid parental leave for both birthing and non-birthing parents
Competitive 401(k) plan with company match that vest immediately
Financial planning services
Corporate discount programs for goods and services
Generous paid time off
Flexible work hours
Flexible work arrangement options

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Quality Auditor - Medical Device

Job Description

Job Responsibility

Requirements

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