Quality Systems Complaints Specialist Job at MillenniumSoft Inc (Sparks, MD)

New

Quality Specialist, Complaints

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

Location

United States , Skaneateles Falls

Salary:

68000.00 - 93500.00 USD / Year

Baxter

Expiration Date

Until further notice

Requirements

Bachelor's degree required
0-2 years of experience in quality assurance, manufacturing or documentation
Experience with quality management systems, including experience in implementing and maintaining QMS
Strong knowledge of quality management systems (e.g., ISO 13485, FDA QSR) and regulatory requirements
Strong communication and interpersonal skills, including experience in working with cross-functional teams
Strong analytical and problem-solving skills, including experience in identifying and resolving quality issues
Proficient in Microsoft Office Suite (Word, Excel, PowerPoint) and quality management software

Job Responsibility

Perform documented customer complaint investigations in accordance with FDA 21 CFR Part 820 and ISO 13485 requirements
Apply structured root cause analysis methodologies to identify nonconformities
Document complaint investigations clearly and accurately
Collaborate cross-functionally with Manufacturing, Engineering, Quality Assurance, and Regulatory Affairs
Draft clear and compliant customer response letters
Support the development and maintenance of the Quality Management System (QMS)
Support regulatory compliance activities
Assist in the planning and execution of internal and external quality audits
Support change control, risk management, and CAPA processes
Contribute to quality systems training activities

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)
401(k) Retirement Savings Plan (RSP)
Flexible Spending Accounts

Fulltime

Quality Systems Specialist

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

Location

Ireland , Dublin

Salary:

Not provided

Baxter

Expiration Date

Until further notice

Requirements

Degree in Science or related discipline
Post qualification experience of at least 1 years in a GMP environment, ideally in a quality role
Experience in dealing with Regulatory Compliance desired
Good problem solving and investigation skills would be beneficial
An ability to work in a dynamic, fast-paced and goal driven environment
Be self-driven
Meticulous in attention to professional standards
Respond well to time constraints
Good professional standards and demonstrates good attention to detail
Ability to work under pressure and meet deadlines

Job Responsibility

Ensure the compilation of Quality Management Review process
Review and approval of process change controls, SOPs, NCRs and CAPAs
Implementation, execution and administration of Change Control System and NCR System
Administration of Recall process with the Quality management team
Administration/co-ordination of risk assessments
Support facility projects including process development and quality improvement initiatives
Manage and maintain the Documentation System
Manage of site archive, storage, retrieval and destruction processes
Review and approval of Quality documentation
Supporting all departmental administration systems as required

What we offer

Support for Parents
Continuing Education/ Professional Development
Employee Heath & Well-Being Benefits
Paid Time Off
2 Days a Year to Volunteer
Competitive total compensation package
Professional development opportunities
High importance placed on work life balance
Pension
Health Insurance

Quality Systems Specialist

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

Location

Ireland , Dublin

Salary:

Not provided

Baxter

Expiration Date

Until further notice

Requirements

Degree in Science or related discipline
Post qualification experience of at least 1 years in a GMP environment, ideally in a quality role
Experience in dealing with Regulatory Compliance desired
Good problem solving and investigation skills would be beneficial
An ability to work in a dynamic, fast-paced and goal driven environment
Be self-driven
Meticulous in attention to professional standards
Respond well to time constraints
Good professional standards and demonstrates good attention to detail
Ability to work under pressure and meet deadlines

Job Responsibility

Ensure the compilation of Quality Management Review process
Review and approval of process change controls, SOPs, NCRs and CAPAs
Implementation, execution and administration of Change Control System and NCR System
Administration of Recall process with the Quality management team
Administration/co-ordination of risk assessments
Support facility projects including process development and quality improvement initiatives
Manage and maintain the Documentation System
Manage of site archive, storage, retrieval and destruction processes
Review and approval of Quality documentation
Supporting all departmental administration systems as required

What we offer

Support for Parents
Continuing Education/ Professional Development
Employee Heath & Well-Being Benefits
Paid Time Off
2 Days a Year to Volunteer
Competitive total compensation package
Professional development opportunities
High importance placed on work life balance
Pension
Health Insurance

Quality Systems Specialist

The Quality Systems Specialist is responsible for ensuring that systems and prod...

Location

Ireland , Dublin

Salary:

Not provided

Baxter

Expiration Date

Until further notice

Requirements

Degree in Science or related discipline
Post qualification experience of at least 1 years in a GMP environment, ideally in a quality role
Experience in dealing with Regulatory Compliance desired
Good problem solving and investigation skills would be beneficial
An ability to work in a dynamic, fast-paced and goal driven environment
Be self-driven
Meticulous in attention to professional standards
Respond well to time constraints
Good professional standards and demonstrates good attention to detail
Ability to work under pressure and meet deadlines

Job Responsibility

Ensure the compilation of Quality Management Review process
Review and approval of process change controls, SOPs, NCRs and CAPAs
Implementation, execution and administration of Change Control System and NCR System
Administration of Recall process with the Quality management team
Administration/co-ordination of risk assessments
Support facility projects including process development and quality improvement initiatives
Manage and maintain the Documentation System
Manage of site archive, storage, retrieval and destruction processes
Review and approval of Quality documentation
Supporting all departmental administration systems as required

What we offer

Competitive total compensation package
Professional development opportunities
High importance placed on work life balance
Pension
Health Insurance
Life Assurance
Support for Parents
Continuing Education/ Professional Development
Employee Heath & Well-Being Benefits
Paid Time Off

Quality Systems Specialist

This position is responsible for owning the quality review of domestic and inter...

Location

United States , Zelienople

Salary:

25.00 - 30.00 USD / Hour

MillenniumSoft Inc

Expiration Date

Until further notice

Requirements

1 to 3 years experience (medical device industry preferred)
Familiarity with service management systems ServiceMax or TrackWise
Proficient skills in Microsoft Office, including Microsoft Word and Excel
Excellent organizational skills and attention to detail
The ability to build relationships within the organization
Ability to multi-task and adapt to changes quickly
Associate degree in Business Management, Medical Office Admin, or related field

Job Responsibility

Process service records for Bard/BD Direct and Contract Service Providers (CSP) by reviewing paperwork for accuracy, completeness and correctness
Coordinate with Field Assurance (FA) in following up with service providers to clarify issues with complaint records so that the records can be closed in a timely manner in accordance with divisional target dates and regulatory requirements
Review and facilitate weekly report meeting for aged service records with division. Request information or documentation to move records to closure
Perform Device History Reviews (DHR) and Process Failure Mode and Effects Analysis (PFMEA) reviews in support of complaint investigations
Communicate problems, situations, opportunities, and progress to management
Additional task requested, as required

Fulltime

Quality Systems Specialist

Interface with other functions to ensure accurate and timely completion and revi...

Location

United States , Franklin Lakes

Salary:

34.00 - 38.00 USD / Hour

MillenniumSoft Inc

Expiration Date

Until further notice

Requirements

Knowledge of US and International regulations and standards that apply to the medical device industry including FDA Quality Systems Regulations, ISO 13485, MDD, EU MDR, Canadian MDR, Japan PMDA as well as ANVISA and TGA requirements
In-depth understanding of the application of quality systems to the medical device industry
Experience with Trackwise and SAP
Advanced proficiency in data analysis tools such as Excel, Qlikview and BI report preferred
Bachelors Degree

Job Responsibility

Interface with other functions to ensure accurate and timely completion and review of documents
Collect and Analyze Quality Data to assist with Management Review content development, CER, PMS, Quality Scorecard, etc.
Supports quality system improvement and standardization initiatives within MDS
Support Post Market Surveillance (EU MDR, Canada, etc.) providing data and supporting the preparation of Post Market Surveillance reports and plans for submission to regulatory bodies
Conduct comprehensive literature searches, review of complaints, corrective and preventive actions, and MAUDE database and summarize in a report for medical devices

Fulltime

New

Specialist Quality Assurance

Responsible for providing oversight and leadership for quality systems execution...

Location

Singapore , Singapore

Salary:

Not provided

Amgen

Expiration Date

Until further notice

Requirements

Doctorate degree OR Master's degree and 2 years of directly related experience OR Bachelor's degree and 4 years of directly related experience OR Diploma and 8 years of directly related experience
8 years related work experience (manufacturing, process development, or quality assurance) in the pharmaceutical / biologics industry with progressively increasing responsibility and demonstrated experience in project management, quality assurance, and quality systems.
Direct experience with bulk manufacturing of biopharmaceuticals/API preferred.
Demonstrated proficiency of written and verbal communication skills (including technical writing and presentations) with ability to communicate and collaborate effectively with technical and senior management staff.
Experience with regulatory audits and inspections
Problem solving skills with the ability to apply logic and assess data to reach decisions and solutions related to compliance and product quality.

Job Responsibility

Provide Quality oversight to plant operations, ensuring appropriate application and execution of GMP compliance requirements and Amgen Quality Management System in plant operations through phases of commissioning, process qualification, regulatory approval and market supply
Support routine GMP documentation review activities (e.g. electronic batch records, SOPs, logbooks, work orders, batch production reports and validation protocols etc.) and ensure key performance indicator met targeted metrics
Co-lead and support the deployment of Amgen quality systems, including management review, validation, change control and CAPA and ensure that the systems are managed in compliance with cGMP expectations
Participate in complex root cause investigations for deviations
Review and approve deviation investigations, change controls, and other quality records (with focus on highly complex records)
Provides Quality Assurance support in New Product Introduction (NPI) team
Coach site Quality Assurance professionals on resolution of complex problems
Participate in regulatory inspections, and interact directly with regulatory inspectors
Supporting other Quality Assurance initiatives/activities such as continuous improvement projects, supplier quality, stability program, product quality review, customer complaint investigation.

What we offer

Vast opportunities to learn and move up and across our global organization
Diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act
Generous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits

Fulltime

Specialist, Quality Complaint Investigation

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

Location

Malta , San Ġwann tal-Għargħar, San Ġwann

Salary:

27200.00 EUR / Year

Baxter

Expiration Date

Until further notice

Requirements

Medical Device Experience with knowledge of 21CFR820 preferred
Investigational research skills
Experience with any statistical software packages (Minitab a plus)
Desired experience in the medical device industry in the development and deployment of Quality Systems, and process controls, and continuous improvement methods
Knowledge and working application of FDA cGMP
ANSI/ISO/ASQC requirements
CMDAS (optional)
Knowledge and working application of reading and understanding blueprints and technical drawings
Demonstrated strong analytical problem solving (Root Cause Investigations
Display a solid technical understanding of engineering principles and procedures (e.g. CAD and its application or scheduling a series of technical tasks utilizing software-based tools)

Job Responsibility

Investigation, review, and completion of all Quality Engineering complaint issue analysis tasks utilizing various quality system inputs
Review individual complaints and associated service data to determine risk level and complete investigation into the as determined problem code and cause codes for each complaint
Analyze data from various quality inputs (including but not limited to: Field Corrective Action (FCA), Complaints, FDA Medical Device Reports (MDR), etc.) to determine trends and systemic issues
Prepare and issue reports based on information analysis
Review existing investigation reports and identify gaps for GMP compliance
Develop strategies and plans to close the gaps in an efficient and technical manner
Develop and communicate expectations for quality performance, continuous improvement and process controls for marketed products
Monitor and drive corrective action and continuous improvement activities that directly impact performance measures by performing primary investigations, conducting data analysis, and implementing corrective actions
Conduct or lead corrective and preventive actions in manufacturing using formal problem-solving tools and documentation
Support CAPA and maintenance activities for existing product lines

What we offer

Support for Parents
Continuing Education/ Professional Development
Employee Heath & Well-Being Benefits
Paid Time Off
2 Days a Year to Volunteer
competitive benefits
discretionary bonuses
long-term incentive

Fulltime

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Quality Systems Complaints Specialist

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