Sr. Principal, Quality Engineer

Aquí es donde salvas y sostienes vidas

En Baxter, estamos profundamente conectados por nuestra misión. No importa tu rol en Baxter, tu trabajo tiene un impacto positivo en la gente alrededor del mundo. Sentirá un propósito en toda la organización, ya que sabemos que nuestro trabajo mejora los resultados para millones de pacientes.

Los productos y terapias de Baxter se encuentran en casi cada hospital del mundo, el clínicas y en los hogares. Por más de 85 años hemos sido pioneros en innovaciones médicas significativas que transforman el cuidado en salud.

Juntos creamos un lugar donde somos felices, exitosos y nos inspiramos mutuamente. Aquí es donde puedes hacer tu mejor trabajo.

Únete a nosotros en la intersección de salvar y sostener vidas-donde tu propósito acelera nuestra misión.

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,