Manager, Quality Assurance

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.  As the Quality Assurance Manager at Baxter you will be responsible for Day-to-day activities of Quality Operations, Quality Assurance, including Inspections/ Batch Release, Compliant Investigations and management oversight of NCRs/ CAPA’s. You will also ensure cGMP compliance and Inspection readiness by ensuring quality and compliance are built into day-to-day operations.

Implementation and improvement of Quality Processes that will assure compliance with Regulations, Corporate and Local procedures, and specifications. Quality Representative in the manufacturing areas. Manage the batch review and release activities. Interfaces with regulators during regulatory inspections/ audits. Identifies, manages and drives continuous Improvement and MIP projects with the objective of achieving quality, reliability, and cost Improvements. Ensure adherence to budget. 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. Promote a zero-harm workplace and assure that required EHS resources are available and that all applicable EHS practices and rules are being followed by supervised employees. 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.

BS in science or engineering preferred with 5+ years’ experience in Quality, Manufacturing, Engineering, or related field which should include 1-2 years of supervisory experience in a Medical Device or Pharma 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 solid understanding of applicable quality and regulatory standards and regulations Comfortable and capable of gowning into an ISO 7/ISO 8 manufacturing environment May perform other duties as assigned We understand compensation is an important factor as you consider the next step in your career. At Baxter, we are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices. The estimated base salary for this position is $112,000 - $154,000 annually. The estimated salary is meant to reflect an anticipated salary range for the position. We may pay more or less than the anticipated range based upon market data and other factors, all of which are subject to change. Individual pay is based on location, skills and expertise, experience, and other relevant factors. This position may also be eligible for