Manager II, Quality Assurance - Solutions Job at Baxter (Cleveland)

Manager II, Quality Assurance - Solutions

As the Manager II, Quality Assurance - Solutions, you will lead all aspects of D...

Location

United States , Cleveland

Salary:

136000.00 - 170000.00 USD / Year

Baxter

Expiration Date

Until further notice

Requirements

Bachelor’s degree in Microbiology, Biology, Chemistry, or Engineering, or equivalent experience, required
5+ years of Engineering/Manufacturing/Quality experience required
3-5 years of leadership experience
FDA regulated manufacturing experience preferred
Six Sigma Green Belt Certification or industry-standard equivalent preferred
Project Management skills and experience are preferred
Experience and skills in Lean Manufacturing are preferred

Job Responsibility

Lead quality oversight for the Devices areas
Develop, assign, and implement systems, procedures, and policies to ensure compliance with ISO Standards, cGMP's, FDA regulations, and company policies
Conduct audits and implement changes to specifications, SOPs, and forms for regulatory compliance and process improvement
Ensure product compliance through established inspection criteria and procedures
Coordinate inspection activities throughout the production cycle
Analyze statistical data and product specifications to determine and improve quality standards
Prepare and submit reports to Managers and other Departments or Agencies as required
Communicate quality philosophy to key personnel
Actively participate in quality management teams within the organization
Manage and support area associates, encouraging a teamwork environment

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

Manager II Quality Assurance Solutions

As the Manager II, Quality Assurance - Solutions, you will lead all aspects of D...

Location

United States , Cleveland

Salary:

136000.00 - 170000.00 USD / Year

Baxter

Expiration Date

Until further notice

Requirements

Bachelor’s degree in Microbiology, Biology, Chemistry, or Engineering, or equivalent experience, required
5+ years of Engineering/Manufacturing/Quality experience required, with 3-5 years of leadership experience
FDA regulated manufacturing experience preferred
Six Sigma Green Belt Certification or industry-standard equivalent preferred
Project Management skills and experience are preferred
Experience and skills in Lean Manufacturing are preferred

Job Responsibility

Lead quality oversight for the Devices areas
Develop, assign, and implement systems, procedures, and policies to ensure compliance with ISO Standards, cGMP's, FDA regulations, and company policies
Conduct audits and implement changes to specifications, SOPs, and forms for regulatory compliance and process improvement
Ensure product compliance through established inspection criteria and procedures
Coordinate inspection activities throughout the production cycle
Analyze statistical data and product specifications to determine and improve quality standards
Prepare and submit reports to Managers and other Departments or Agencies as required
Communicate quality philosophy to key personnel
Actively participate in quality management teams within the organization
Manage and support area associates, encouraging a teamwork environment

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

Manager II Quality Assurance Solutions

As the Manager II, Quality Assurance - Solutions, you will lead all aspects of D...

Location

United States , Cleveland

Salary:

136000.00 - 170000.00 USD / Year

Baxter

Expiration Date

Until further notice

Requirements

Bachelor’s degree in Microbiology, Biology, Chemistry, or Engineering, or equivalent experience, required
5+ years of Engineering/Manufacturing/Quality experience required
3-5 years of leadership experience
FDA regulated manufacturing experience preferred
Six Sigma Green Belt Certification or industry-standard equivalent preferred
Project Management skills and experience are preferred
Experience and skills in Lean Manufacturing are preferred

Job Responsibility

Lead quality oversight for the Devices areas
Develop, assign, and implement systems, procedures, and policies to ensure compliance with ISO Standards, cGMP's, FDA regulations, and company policies
Conduct audits and implement changes to specifications, SOPs, and forms for regulatory compliance and process improvement
Ensure product compliance through established inspection criteria and procedures
Coordinate inspection activities throughout the production cycle
Analyze statistical data and product specifications to determine and improve quality standards
Prepare and submit reports to Managers and other Departments or Agencies as required
Communicate quality philosophy to key personnel
Actively participate in quality management teams within the organization
Manage and support area associates, encouraging a teamwork environment

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

Specialist II, Product Quality Assurance

The Specialist, NC Product Quality Assurance (PQA) will be responsible for suppo...

Location

United States , Durham, NC

Salary:

105000.00 - 145000.00 USD / Year

Beam Therapeutics

Expiration Date

Until further notice

Requirements

Bachelors or Advanced degree in a scientific discipline
10+ years’ experience in the pharmaceutical/biotech industry in combination with drug substance/drug product manufacture, development and/or quality
Knowledge of aseptic processing, and/or cell and gene therapy is preferred
Apply Quality concepts and company policies to resolve issues of moderate complexity in an effective manner
Excellent verbal and written communication skills, detail-oriented personality, and ability to work collaboratively across functions
Knowledge of global regulations and standards
Strong team player that has a customer service approach and is solution oriented
Attention to detail and the ability to work individually as well as within a multi-disciplinary team
Excellent listening, communication and interpersonal skills with a team focus
Consistent delivery of high-quality work

Job Responsibility

Provide Quality oversight of on-the-floor activities including manufacturing shop floor presence during operations
Provide Quality oversight of QC testing
Responsible for ensuring GMP compliance with applicable procedures and production requirements in QC, manufacturing, and facilities operations
Responsible for assisting with product disposition activities of supply produced at the manufacturing facility
Real time review of batch records and labels
Review and approval of manufacturing discrepancies and associated CAPA’s
Communicating lot disposition pending issues to management
Aid in the development and ongoing improvement of applicable quality systems for the site
identifying gaps or improvements, authoring and approval of procedures, and providing training, as needed
Review and approve calibration and maintenance work orders and asset inductions

Fulltime

Quality Assurance Financial Auditor II

The Quality Assurance Financial Auditor II is responsible for performing Quality...

Location

United States

Salary:

51000.00 - 80070.00 USD / Year

Healthfirst

Expiration Date

Until further notice

Requirements

Audit experience with the investigation, determination and reporting of financial processes
Work experience in Microsoft Office suite of applications including advanced Excel, Word, PowerPoint
Experience conducting root cause analysis in an auditing capacity
Experience conducting analytical work and providing creative ideas for problem solving
Work experience requires written and verbal communication that is clear, concise, grammatically correct, and professional
Experience handling confidential information
Associate degree from an accredited institution

Job Responsibility

Conduct moderately complex to complex quality audits of provider claims, pre-payments and post-payments including high-dollar and specialized claims across multiple lines of business, claim types and products
Audit the work of more junior auditors and identify opportunities for coaching and/or training
Identify and communicate issues identified through audits and recommended solutions relevant to business operations
Assist management in preparing departmental reports policies and procedures
Mentor and coach Financial and/or Operations QA auditors
Participate as a Subject Matter Expert on various process improvement projects designed to meet departmental and operational needs
Assist with performing User Acceptance Testing (UAT) on system enhancements or corporate projects in partnership with Business Operations
Analyze errors and determine root causes for appropriate classification
Record/track quality assessment scores and provide feedback to reduce errors and improve processes and performance to ensure the quality of the network
Review and investigate claims and encounters for medical, facility, pharmacy, dental and vision services including contractual provisions, authorizations and Healthfirst policy and procedure

What we offer

medical, dental and vision coverage, incentive and recognition programs, life insurance, and 401k contributions

Fulltime

Design Assurance Engineer II

The Design Assurance Engineer II position supports product development to ensure...

Location

United States , Burnsville

Salary:

80000.00 - 110000.00 USD / Year

Imricor Medical Systems

Expiration Date

Until further notice

Requirements

Bachelor of Science in Engineering, Science, or technical field
2+ years’ experience in Engineering and/or Quality. Additional education may be substituted for years of experience.
Must be able to work independently under limited supervision.
Knowledge of basic Quality Systems and good documentation practices.
Experience in investigating and implementing Corrective and Preventive Actions
Experience in design controls and test method validation
Experience with European Medical Device Regulations, FDA 21 CFR Regulations, Australian TGA Regulations, ISO 14971, ISO 13485
Advanced computer skills, including statistical/data analysis and protocol/report writing.
Strong communication skills, both verbal and written
Comfortable working with and seeking optimum solutions with team members in adjacent disciplines of engineering

Job Responsibility

Executes and supports completion of product development deliverables
Creates and supports the development of DHF to ensure content is complete, accurate, and compliant with regulatory standards
Supports the development and maintenance of customer requirements, product requirements, and product specifications
Collaborates cross-functionally to lead and support completion and maintenance of product risk management deliverables
Authors design verification and design validation plan and report documents
Implements appropriate sampling inspection and supports qualification activities for purchased components
Supports design test method development, and leads method validation activities
Utilizes statistical techniques to lead and support characterization, verification, and validation testing and root cause analysis
Supports quality system-related deliverables including nonconformances and CAPAs
Performs other related duties and responsibilities, as assigned

What we offer

Medical
Dental
Vision
Health Savings Accounts
Health Care & Dependent Care Flexible Spending Accounts
Disability Benefits
Life Insurance
Retirement Benefits

Fulltime

Security Solutions Architect II

Join Allied Universal® Technology Services, a global leader in transforming the ...

Location

United States , Carrollton

Salary:

Not provided

Allied Universal®

Expiration Date

Until further notice

Requirements

High school diploma or equivalent
Experience working with access control and video systems
Licensing requirements are subject to state and/or local laws and regulations and may be required prior to employment
Must possess one or more of the following: Minimum of three (3) years of experience with integrated electronic security solutions
Minimum of two (2) years of experience in a pre-sales support/engineering position
Working knowledge of network Infrastructure Including switches, routers, IP configuration
Knowledge of advanced Video analytics
Knowledge of Software as a Service (SAAS) and Cloud based security solutions
Ability to work in a dynamic environment
capable of managing multiple tasks, setting priorities, and meeting deadlines

Job Responsibility

Conduct site walkthroughs with client and sales understanding the need
Develop technical solutions that map customer business requirements to security technology solutions
Generation of technical scopes of work (SOW) and detailed design narratives for technical solutions and associated cost estimates
Manage estimation process to include interfacing with multiple representatives of sales, management, and customer teams
Analyze blueprints, construction drawings, and technical/functional design specifications to prepare compliant solutions
Research emerging technologies in support of security integration solutions
Interface with product and distribution partners to obtain systems, device, and equipment pricing during estimating process
Support Sales Team by participating in technical discussions and meetings with customers and/or product partners, to include ROI (Return on Investment) conversations and presentations
Understanding construction divisions, as they relate to Electronics -Safety and Security for RFP responses
Maintain quality assurance by following organization and department standards

What we offer

Medical, dental, vision, retirement plan, basic life, AD&D, and disability insurance
Eight paid holidays annually, five sick days, and four personal days
Vacation time is offered at an accrual rate of 3.08 hours biweekly. Unused vacation is only paid out where required by law.
Employee Assistance Program
Employee Discount Program
Tuition Discount Program
Training & Career Development Programs

Fulltime

Solutions Architect II

Allied Universal is hiring a Solutions Architect II to support the achievement o...

Location

United States , Lombard

Salary:

80000.00 - 95000.00 USD / Year

Allied Universal®

Expiration Date

Until further notice

Requirements

A high school diploma required
bachelor’s degree in related field preferred
equivalent work experience may be considered in lieu of a degree
A minimum of 7 years relevant experience with integrated electronic security solutions or 5 years of experience in a pre-sales support or engineering position
Industry technology certifications such as PSP, CCNA
or product specific certification in Access Control and IP Video platforms
Working knowledge of network infrastructure, including switches, routers, IP configuration, CCNA or equivalent certification, is preferred
Ability to work in a fast-paced environment
capable of managing multiple tasks, setting priorities, and meeting deadlines
Must possess excellent written and verbal communication skills

Job Responsibility

Develop technical solutions that map customer business requirements to security technology solutions
Generation of technical scopes of work (SOW) and detailed design narratives for technical solutions and associated cost estimates
Manage estimation process to include interfacing with multiple representatives of sales, management, and customer teams
Analyze blueprints, construction drawings, and technical/functional design specifications to prepare compliant solutions
Research emerging technologies in support of security integration solutions
Interface with product and distribution partners to obtain systems, device, and equipment pricing during estimating process
Support the sales team by participating in technical discussions and meetings with customers and/or product partners
Support the Sales Team in customer-facing ROI (Return on Investment) discussions and technical presentations
Understanding construction divisions as they relate to electronics safety and security for RFP responses
Maintain quality assurance by following organization and department standards

What we offer

Medical, dental, vision, retirement plan, basic life, AD&D, and disability insurance
Eight paid holidays annually, five sick days, and four personal days
Vacation time is offered at an accrual rate of 3.08 hours biweekly
Employee Assistance Program
Employee Discount Program
Tuition Discount Program
Training & Career Development Programs

Fulltime

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Manager II, Quality Assurance - Solutions

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