Quality Assurance Manager

About the Role

The role encompasses overseeing day-to-day Quality Operations, including Quality Assurance, inspections and product release, compliant investigations, and the management of nonconformance reports (NCRs) and corrective and preventive actions (CAPAs). It ensures continuous cGMP compliance and inspection readiness by embedding quality and compliance into routine operations. Additionally, the position involves leading a team of quality professionals to develop, implement, and sustain plant-wide quality engineering practices in alignment with Baxter standards and regulatory quality system requirements.

• Implementation and improvement of Quality Processes that will ensure compliance with Regulations, Corporate and Local procedures, and specifications.
• Interfaces with regulators during regulatory inspections/audits.
• Support change control activities for manufacturing operations.
• Manage the release process, inspection, and batch release activities.
• Oversee, initiate, investigate and approve non-conformance report activities as needed.
• Develop and analyze statistical data and product specifications to determine present standards and establish proposed finished product’s quality and reliability expectancy.
• Apply standard operating practices and problem‑solving methodology across the organization.
• Serve as role model and coach employees at all levels in the application of best practices.
• Drive continuous improvement of processes and systems locally and across corporate initiatives to achieve quality, reliability, and cost improvements.
• Ensure adherence to specifications and procedures that have been established to ensure product quality within area of responsibility.
• Interact frequently with all levels of internal management as well as across functions and franchises.
• Manage overall coaching, training, development and succession plans for the team.
• Identify and lead projects and initiatives to improve the quality system.
• Interact with the larger organization on projects and initiatives as assigned.
• Financial responsibilities and accountability include department and capital budgeting and expenditure for areas of responsibility.

• BS in science or engineering.
• 5+ years’ experience in Quality, Manufacturing, Engineering, or related field, including 2+ years of supervisory experience in the Medical Device industry.
• Thorough knowledge of applicable procedures, specifications, regulations, and standards.
• Strong leadership skills and demonstrated success in managing mid‑to‑large teams.
• Capable of managing in matrixed environments and interacting successfully with multi‑functions globally.
• Strong analytical and problem‑solving skills.
• Good communication and interpersonal skills, including influencing, negotiation, and project management.
• Good working knowledge of applicable quality and regulatory standards and regulations.
• Comfortable and capable of gowning into an ISO 7/ISO 8 manufacturing environment.
• Excellent command of process validation and risk management for medical devices.
• Demonstrated experience managing quality personnel, specifically Quality Engineers, and developing teams.
• Experience with mechanical and biological products, and/or chemical processing.
• Previous Quality Auditing experience is desirable.
• Ability to set statistically valid inspection requirements, including identifying test methods and sampling plans and assist with designing inspection fixtures.
• Assure measurement systems are capable using MSA, when applicable.

The estimated base salary for this position is $112,000 – $154,000 annually. This figure may vary based on market data and other factors.

• Medical and dental coverage starting on day one.
• Coverage for basic life, accidental, short‑term and long‑term disability, and business travel accident insurance.
• Employee Stock Purchase Plan (ESPP) allowing purchase of company stock at a discount.
• 401(k) Retirement Savings Plan (RSP) with employee and company matching options.
• Flexible Spending Accounts and educational assistance programs.
• Paid holidays, paid time off ranging from 20 to 35 days based on length of service, family and medical leave, and paid parental leave.
• Commuting benefits, Employee Discount Program, Employee Assistance Program (EAP), and childcare benefits.

Baxter evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.