Senior Quality Engineer

Base pay range

$/yr - $/yr

Annual Bonus and Stock options

📍 Bedford, MA | 4 days onsite (required)

This is an exciting opportunity to join a growing medical device company at a key point in its evolution, with quality playing a meaningful role in product development and long‑term success.

The organization has a strong leadership team, a quality‑driven culture, and a growing product portfolio. With both established and next‑generation programs in play, this role offers the chance to work upstream in design, influence technical decisions, and help ensure products are developed with quality and patient safety built in from the start.

If you’re a Senior Quality Engineer who enjoys partnering closely with R&D, owning design quality, and working in a hands‑on, collaborative environment, this is a compelling opportunity.

The Senior Quality Engineer – Design will be a key contributor to new product development, serving as the Quality representative on cross‑functional design teams. This is a design‑focused quality role, not a manufacturing‑only or reactive quality position.

You’ll work closely with R&D and Engineering to support design controls, risk management, verification and validation, and regulatory readiness.

• Act as the Quality lead on design and development projects
• Own and support design controls, including:
• Risk management (FMEA, hazard analysis)
• Design inputs and outputs
• Design reviews
• Verification and validation activities
• Partner with R&D to ensure products are designed for patient safety, regulatory compliance, and quality by design
• Support sterility and biological testing and validation as required
• Help develop, implement, and improve the Quality Management System (QMS)
• Ensure compliance with FDA cGMP, ISO 13485, and EU MDR
• Support and participate in FDA and Notified Body audits
• Conduct internal and external audits
• Support CAPA activities, complaint handling, and supplier quality
• Provide technical leadership and mentorship to Quality Engineers and junior team members

• Bachelor’s degree in Engineering, Science, or related field
• 4+ years of medical device Quality experience
• Strong experience with:
• Design controls
• Risk management (FMEA, hazard analysis)
• Verification and validation
• Working knowledge of FDA, ISO 13485, and EU MDR
• Experience participating in audits
• Comfortable working cross‑functionally with R&D and Engineering
• Strong communication, organization, and problem‑solving skills

• Experience supporting products moving from development toward commercialization
• Prior experience mentoring or guiding other Quality Engineers

• Bedford, MA
• 4 days per week onsite (this is a firm requirement)
• Occasional travel as needed (audits, suppliers)

✔ Senior QEs who enjoy upstream design quality work

✔ Those who want real influence in product development

✔ Engineers who value collaboration over bureaucracy

✖ Manufacturing‑only or shop‑floor‑focused Quality roles

✖ Narrow CAPA/NCR‑only positions

If you’re interested in a Senior Quality Engineer role where design quality, collaboration, and technical impact matter, we’d love to connect.

• Mid‑Senior level

• Full‑time

• Quality Assurance and Engineering

• Medical Equipment Manufacturing and Engineering Services