Design Quality Assurance Engineer III - Endoscopy
About The Position
The Design Quality Assurance Engineer III leads complex design-related nonconformance (NCEP) and corrective and preventive action (CAPA) activities throughout the product lifecycle. The role supports the Endoscopy Division design site, working with cross-functional development teams to ensure product safety, quality, and regulatory compliance while improving commercial value. The position also supports quality process improvements and quality systems initiatives related to design and development. This hybrid role is based in Marlborough, Massachusetts, and requires on-site work at least three days per week. Travel is approximately 10–20%. Relocation assistance and visa sponsorship are not available for this position.
Requirements
- Bachelor of Science degree in Biomedical Engineering, Mechanical Engineering, or a related field.
- At least 3 years of medical device engineering experience.
- Detailed understanding and working knowledge of U.S. and international medical device requirements, including 21 CFR Part 820, the Medical Device Directive (MDD) and Medical Device Regulation (EU MDR), EN ISO 13485, and EN ISO 14971.
- Proven experience leading and owning CAPAs in a design environment.
- Proficiency in root cause analysis tools and methodologies.
- Approximately 10–20% travel.
Nice To Haves
- At least 5 years of medical device engineering experience.
- Proficiency in Minitab Statistical Analysis software or equivalent.
- Six Sigma certification.
- Strong technical expertise in quality engineering principles, design controls, risk management, and problem-solving methodologies.
- Excellent communication, presentation, and interpersonal skills, including the ability to influence teams and leadership.
- Proven ability to lead and coach others and foster a high-performance quality culture.
- Strategic mindset with hands-on execution, balancing long-term objectives with immediate project needs.
Responsibilities
- Lead and provide quality oversight for complex design-related NCEP/CAPA activities, ensuring timely progress and compliance with regulatory and Quality System requirements.
- Lead teams through complex investigations and problem-solving initiatives using technical knowledge.
- Apply systematic methods such as 5 Whys, Is-Is Not, DMAIC, and Six Sigma to identify root causes, optimize processes, and establish sustained corrective actions.
- Partner with cross-functional teams to develop risk-appropriate corrective and preventive actions that address identified causes and support sustainable solutions.
- Provide quality and compliance input to project teams on project decisions and deliverables, including Design Change Analysis, Design Inputs and Outputs, Test Methods, Design Reviews, Design V&V, Usability Testing, Process Validation, and Labeling.
- Guide and mentor engineers, and coach them on quality engineering methodologies and problem-solving techniques.
- Represent quality within cross-functional teams, influence project direction, and ensure adherence to regulatory requirements, internal procedures, and quality practices.
- Identify and implement best practices for the department.
- Proactively identify and implement opportunities to improve or enhance company quality systems and processes.
- Support internal and external regulatory audits as required.
Benefits
- Core and optional employee benefits are offered; specific benefits are not detailed in the posting.
- Annual bonus target and long-term incentives may be available for eligible exempt, non-sales roles, subject to plan requirements.
- Variable compensation, including overtime, shift differential, and an annual bonus target, may be available for eligible non-exempt, non-sales roles, subject to plan requirements.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
