Quality Engineer III
Listed on 2026-07-04
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Quality Assurance - QA/QC
Quality Engineering, Regulatory Compliance Specialist, Production QC/QA
Location(s)
US‑MN‑Maple Grove
About the roleBoston Scientific was recognized by Forbes as one of the Best Workplaces for Engineers in 2026. This team is seeking a Principal Quality Engineer to support the Core Technology Polymer team within Maple Grove Operations. In this role, you will develop, implement and maintain quality engineering systems, methodologies and practices that ensure compliance with Boston Scientific, customer and regulatory requirements.
As a key Quality representative, you will provide technical leadership and partner across functions to drive quality initiatives that support operational excellence, product quality and business objectives. You will play a critical role in process validation, risk management, process controls and continuous improvement efforts, ensuring products consistently meet internal and external requirements throughout the product lifecycle. Working in a collaborative environment, you will lead quality engineering projects, mentor technical team members and apply data‑driven problem‑solving approaches to identify, resolve and prevent quality issues while strengthening manufacturing processes and quality system effectiveness.
Workmodel, sponsorship, relocation
This is an onsite position at the Maple Grove, MN office. Boston Scientific will not offer sponsorship or relocation assistance for this role.
Responsibilities- Lead departmental and cross‑functional quality engineering initiatives that support business and operational objectives.
- Provide project leadership, coaching and technical mentorship to engineering and quality team members.
- Drive implementation of best‑in‑class quality engineering practices and continuous improvement initiatives.
- Lead process validation, verification and risk management activities to ensure product and process robustness.
- Develop and implement effective process controls that support product development, qualification and ongoing manufacturing.
- Support and strengthen quality system processes, including CAPA, investigations and process monitoring activities.
- Apply structured problem‑solving methodologies to identify, prioritize and resolve quality issues.
- Partner with manufacturing, process engineering, supplier quality and cross‑functional teams to drive sustainable improvements.
- Analyze quality and manufacturing data to identify trends, risks and opportunities for improvement.
- Ensure compliance with applicable quality system requirements, documentation standards and regulatory expectations.
- Minimum bachelor’s degree in engineering or a related technical discipline and at least five years of experience in quality engineering, manufacturing engineering or a related technical field.
- Proven experience supporting process validation, verification and risk management activities, including Design and Process FMEAs.
- Demonstrated knowledge of statistical analysis, data interpretation and quality engineering tools.
- Strong written, verbal and presentation skills with the ability to communicate effectively across organizational levels.
- Ability to work independently and manage multiple priorities in a fast‑paced environment.
- Working knowledge of quality systems and good documentation practices.
- Experience managing multiple projects across diverse engineering disciplines.
- Medical device industry experience supporting manufacturing operations.
- Demonstrated ability to identify and implement process improvement opportunities.
- Experience leading cross‑functional teams and driving projects to successful completion.
- Experience with CAPA, post‑market quality, supplier quality, risk management and manufacturing engineering processes.
- Proficiency with Microsoft Office applications, including Word, Excel, PowerPoint and Outlook.
- Familiarity with manufacturing execution systems (MES), product documentation, inspection and testing methodologies.
Requisition
Salary Range: $78,300 – $148,800 (annual)
Compensation will be commensurate with demonstrable level of experience and training, pertinent education, licensure and certifications. For exempt and non‑exempt positions, variable compensation may include annual…
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