Quality Assurance Manager

Responsibilities

• 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.
• Drives continuous improvement of processes and systems locally as well as deployment of such divisional and corporate initiatives with the objective of achieving quality, reliability, and cost improvements.
• Responsible for adherence to specifications and procedures that have been established to ensure product quality in area of responsibility.
• Interacts frequently with all levels of internal management as well as across functions and franchises.
• Manages overall coaching, training, development and succession plans for the team.
• Identify and lead projects and initiatives to improve the quality system. Interact with Baxter larger organization on projects and initiatives as assigned.
• Financial responsibilities and accountability include department and capital budgeting and expenditure for areas of responsibility.

Requirements

• BS in science or engineering. 5+ years' experience in Quality, Manufacturing, Engineering, or related field which should include 2+ years of supervisory experience in 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 matrix and ability to interact successfully with multi-functions globally.
• Strong analytical and problem-solving skills.
• Ability to manage/supervise a team of employees.
• Good communication and leadership skills.
• Good interpersonal/communication/influencing/negotiation skills.
• Good project management skills.
• 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, managing performance and developing teams.
• Prior supervisory/leadership experience
• Experience with mechanical and biological products, and/ or chemical processing
• Previous Quality Auditing experience is desirable.
• 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.

Benefits

Additional Information

This is where your work makes a difference. At Baxter, we believe every person-regardless of who they are or where they are from-deserves a chance to live a healthy life. It was our founding belief in 1931 and continues to be our guiding principle. We are redefining healthcare delivery to make a greater impact today, tomorrow, and beyond. Our Baxter colleagues are united by our Mission to Save and Sustain Lives. Together, our community is driven by a culture of courage, trust, and collaboration. Every individual is empowered to take ownership and make a meaningful impact. We strive for efficient and effective operations, and we hold each other accountable for delivering exceptional results. Here, you will find more than just a job-you will find purpose and pride. Your 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 ongoing 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.

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