Sr. Principal, Quality Engineer

This is where you save and sustain lives

At Baxter, we are deeply connected by our mission. No matter your role at Baxter, your work makes a positive impact on people around the world. You'll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients.

Baxter's products and therapies are found in almost every hospital worldwide, in clinics and in the home. For over 85 years, we have pioneered significant medical innovations that transform healthcare.

Together, we create a place where we are happy, successful and inspire each other. This is where you can do your best work.

Join us at the intersection of saving and sustaining lives- where your purpose accelerates our mission.

Your Role at Baxter

Baxter is seeking a dynamic and experienced Sr Principal Quality Engineer to lead quality activities and production support of the Carnation Ambulatory Monitor (CAM). The candidate will contribute to the successful qualification of new manufacturing processes, production line extensions, and design/process changes. The candidate will work closely with our local contract manufacturer to ensure timely resolution of product quality issues and oversee production lot release activities. In addition, the candidate will provide guidance on statistical methods, conduct risk management activities, and lead special projects to support the business. The ideal candidate will have extensive experience working in the medical device industry and a proven track record collaborating with internal and external teams.

What you will be doing

• Provide Sustaining Quality Engineering support for commercialized products - directly responsible for production and process control activities.
• Provide production line support, including the review and approval of DHRs, NCMR/CAPA/Deviation initiation and resolution, and manufacturing process audits.
• Contribute to the qualification of manufacturing processes, equipment, new production lines, and process/design changes (change control).
• Support/lead the Supplier Quality management and purchasing controls process. Oversee qualification of new suppliers and surveillance of existing suppliers. Perform supplier audits of critical suppliers and contract manufacturers.
• Generate and provide guidance/feedback on quality records, including but not limited to design inputs/outputs, requirements, test plans, and test reports.
• Provide guidance on statistical methods and analysis for Design V&V, manufacturing process validation, and test method validation (attribute and variable).
• Conduct risk management activities: hazard analysis, risk analysis, identify and evaluate risk control measures, and health hazard evaluations.
• Lead special projects to support the business, as needed.
• Follow documented procedures for all activities related to the Bardy Dx Quality System.

What do you bring

• Bachelor's degree in engineering or related scientific field.
• Minimum of eight (8) years of experience in a regulated quality assurance, quality engineering, and/or regulatory affairs position.
• Working knowledge of US and international medical device quality system regulations, including 21 CFR Part 820, MDD/MDR, ISO 13485:2016, and MDSAP.
• Working knowledge of medical device hardware and software development best practices.
• Strong interpersonal, verbal, and written communication skills.
• Organized self-starter, able to work in a fast-paced environment.
• Ability to work independently and as part of team; strong collaborative skills.
• Creative problem solver.
• Proficient in Microsoft Office, Adobe Acrobat, and statistical analysis software.

Baxter is committed to supporting the needs for flexibility in the workplace. We do so through our flexible workplace policy which includes a required minimum number of days a week onsite. This policy provides the benefits of connecting and collaborating in-person in support of our Mission. The flexible workplace policy is subject to local laws and legal requirements. At its discretion, Baxter may decide to adjust, suspend, or discontinue as business needs change.

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 our employees, and we strive to be more transparent with our pay practices. To that end, this position has a salary range of $120,000 to $165,000 and also includes an annual incentive bonus. The above range represents the expected salary range for this position. The actual salary may vary based upon several factors including, but not limited to, relevant skills/experience, time in the role, business line, and geographic/office location. #LI-ASR2

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: Benefits | Baxter

Equal Employment Opportunity

Baxter is an equal opportunity employer. Baxter evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.

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Reasonable Accommodations

Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please click on the link here and let us know the nature of your request along with your contact information.

Recruitment Fraud Notice

Baxter has discovered incidents of employment scams, where fraudulent parties pose as Baxter employees, recruiters, or other agents, and engage with online job seekers in an attempt to steal personal and/or financial information. To learn how you can protect yourself, review our Recruitment Fraud Notice.