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.
What You'll Be Doing
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.
What You'll Bring
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.
Thorough knowledge of applicable procedures, specifications, regulations, and standards.
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.
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:
