Manager, Quality Assurance,
Baxter International Inc. · Hayward, CA · 2 wk ago
Quality Assurance$112k–$154k/yrFull-time
About the Role
At Baxter, we believe every person deserves a chance to live a healthy life. As the Quality Assurance Manager, you will drive day-to-day Quality Operations, ensuring cGMP compliance and inspection readiness. Your work will directly impact our mission to save and sustain lives through efficient, effective, and accountable operations.
Responsibilities
- Implement and improve Quality Processes to assure compliance with regulations, corporate and local procedures, and specifications.
- Serve as Quality Representative in manufacturing areas.
- Manage batch review and release activities.
- Interface with regulators during inspections and audits.
- Identify, manage, and drive continuous improvement and MIP projects for quality, reliability, and cost improvements.
- Ensure adherence to budget.
- Support change control activities for manufacturing operations.
- Oversee, initiate, investigate, and approve non-conformance report activities.
- Promote a zero-harm workplace and ensure EHS practices are followed.
- Ensure adherence to specifications and procedures for product quality.
- Interact with all levels of internal management and cross-functional teams.
- Manage coaching, training, development, and succession plans for the team.
Requirements
- BS in science or engineering preferred.
- 5+ years’ experience in Quality, Manufacturing, Engineering, or related field, including 1-2 years of supervisory experience in Medical Device or Pharma Industry.
- Thorough knowledge of applicable procedures, specifications, regulations, and standards.
- Strong leadership skills with demonstrated success managing mid to large teams.
- Ability to manage in a matrix environment and interact globally across functions.
- Strong analytical and problem-solving skills.
- Good communication, interpersonal, influencing, and negotiation skills.
- Good project management skills.
- Solid understanding of applicable quality and regulatory standards.
- Comfortable gowning into an ISO 7/ISO 8 manufacturing environment.
- Applicants must be authorized to work for any employer in the U.S. (Sponsorship not available at this time).
Pay
The estimated base salary for this position is $112,000 - $154,000 annually. Individual pay is based on location, skills, expertise, experience, and other relevant factors. This position may also be eligible for discretionary bonuses.
Benefits
- Medical and dental coverage starting on day one.
- Insurance coverage for basic life, accident, short-term and long-term disability, and business travel accident.
- Employee Stock Purchase Plan (ESPP) with company stock at a discount.
- 401(k) Retirement Savings Plan with company matching.
- Flexible Spending Accounts.
- Educational assistance programs.
- Paid holidays and 20–35 days of paid time off based on length of service.
- Family and medical leaves of absence, including paid parental leave.
- Commuting benefits.
- Employee Discount Program.
- Employee Assistance Program (EAP).
- Childcare benefits.