This is whereyour work makes a difference.
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 27s. You will also ensure cGMP compliance and Inspection readiness by ensuring quality and compliance are built into day-to-day operations.
What you'll be doing- 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.
What you'll bring- BS in science or engineering preferred with 5+ years97experience 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 discretionary bonuses. For questions about this, our pay philosophy, and available benefits, please speak to the recruiter if you decide to apply and are selected for an interview.
Applicants must be authorized to work for any employer in the U.S. We are unable to sponsor or take over sponsorship of an employment visa at this time.
US Benefits at Baxter (except for Puerto Rico)
This is where your well-being matters. Baxter offers comprehensive compensation and benefits packages for eligible roles. Our health and well-being benefits include medical and dental coverage that start on day one, as well as insurance coverage for basic life, accident, short-term and long-term disability, and business travel accident insurance. Financial and retirement benefits include the Employee Stock Purchase Plan (ESPP), with the ability to purchase company stock at a discount, and the 401(k) Retirement Savings Plan (RSP), with options for employee contributions and company matching. We also offer Flexible Spending Accounts, educational assistance programs, and time-off benefits such as paid holidays, paid time off ranging from 20 to 35 days based on length of service, family and medical leaves of absence, and paid parental leave. Additional benefits include commuting benefits, the Employee Discount Program, the Employee Assistance Program (EAP), and childcare benefits. Join us and enjoy the competitive compensation and benefits we offer to our employees.For additional information regarding Baxter US Benefits, please speak with your recruiter or visit our Benefits site:
