Your Role at Baxter
This is where my hands make life-sustaining products
As a Senior Engineer, Design Quality, you will serve as the quality partner for New Product Development and Sustaining Engineering projects. You will provide quality oversight throughout the product lifecycle, ensuring design controls, regulatory requirements, and quality standards are met. Working closely with cross-functional teams, you will identify and mitigate quality risks while helping deliver safe, effective, and compliant medical devices.
Your Team
You will join a collaborative Quality team that partners with R&D, Regulatory Affairs, Manufacturing, and Supplier Quality to bring innovative healthcare products to market. Together, you will drive quality excellence, support compliance, manage risk, and help improve outcomes for patients around the world.
What we offer from Day One
- Shift flexibility to trade shifts and leverage overtime opportunities
- Medical, Dental and Vision coverage
- 160 hours of Paid Time Off and Paid Holidays
- 401K match
- Employee Stock Purchase Program
- Paid Parental Leave
- Tuition Reimbursement
What you’ll be doing
- Responsible for providing Quality support and oversight via direct staff supervision or process/area responsibilities.
- Identify and assess regulatory and quality risk in activities and processes according to regulatory agency rules and guidelines and Baxter quality practices.
- Provide quality assurance support and oversight for product design activities including: Design and Development Planning, Design Input, Design Output, Design Review, Design Verification and Validation, Design Transfer, Design Changes.
- Ensure compilation and maintenance of product Design History Files in collaboration with R&D.
- Partner with Sustaining Engineering and Research & Development to ensure design reviews are thorough and robust.
What you’ll bring
- Bachelor’s degree in engineering
- 3-5 years experience in Quality with a medical device / Pharma company or other similarly regulated industry.
- Strong problem-solving and root cause analysis skills.
- Experience with structured methods such as 5 Why, fault tree analysis, design or process Failure Modes and Effects Analysis, DMAIC, or equivalent approaches is preferred.
- Demonstrated working knowledge of medical device design controls and product lifecycle management for New Product Development and sustaining activities.
- Working knowledge of applicable quality system and risk management requirements, including ISO 13485, ISO 14971, Regulation (EU) 2017/745, and U.S. FDA Quality System requirements. Knowledge of applicable IECand ISO product standards (ex: IEC 62304, IEC 60601-1, ISO 62366-1, etc…) is expected for the assigned product scope
- Ability to review technical documentation and determine whether requirements, methods, results, conclusions, and traceability are scientifically and objectively supported
- Ability to apply or critically review statistical methods used for verification, validation, reliability, sampling, and process or product data analysis.
- Strong written and verbal communication skills. Able to explain complex quality or technical topics clearly to technical teams and management.
- Self-motivated, organized, detail oriented, and able to manage multiple priorities while maintaining accurate and complete records.
- Ability to challenge constructively, make decisions, and escalate concerns when evidence is insufficient or patient safety, product quality, or compliance may be affected. · Experience supporting audits or regulatory inspections is preferred.
- Professional certification in quality engineering, reliability, software quality, Lean, or Six Sigma is preferred.
- Experience with working in an environment subject to compliance with 21 CFR Parts 820, and FDA Inspection experience preferred.
Applicants must be authorized to work for an employer in the U.S. We are unable to sponsor or take over sponsorship of an employment visa at this time.
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 $96,000 - $132,000 annually. The estimated range is meant to reflect an anticipated salary range for the position. We may pay more or less than of the anticipated range based upon market data and other factors, all of which are subject to change. Individual pay is based upon location, skills and expertise, experience, and other relevant factors. This position may also be eligible for discretionary bonuses, commission, and/or long-term incentive.
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: Benefits | Baxter
