Senior Quality Engineer

Pragmatic; Bedford (MA); On-site; USD 120,000 - 140,000; Full time

Job summary

A growing medical device company is seeking a Senior Quality Engineer to lead design quality for new product development. This role requires collaboration with R&D and engineering to ensure compliance with regulatory standards like FDA and ISO 13485. Ideal candidates have a Bachelor's degree and 4+ years of experience in medical device quality. Strong skills in design controls and risk management are essential, along with excellent communication abilities. This full-time position is based in Bedford, MA, requiring 4 days onsite.

Qualifications

• 4+ years of medical device quality experience.
• Strong experience with design controls.
• Comfortable working cross-functionally with R&D and Engineering.

Responsibilities

• Act as the Quality lead on design and development projects.
• Own and support design controls, including risk management.
• Conduct internal and external audits.

Skills

Design controls

Risk management (FMEA, hazard analysis)

Verification and validation

Strong communication skills

Problem-solving skills

Education

Bachelor’s degree in Engineering, Science, or related field

Tools

FDA regulations

ISO 13485

EU MDR

Job description

Base pay range

$120,000.00/yr - $140,000.00/yr

Additional compensation types

Annual Bonus and Stock options

Location & schedule

📍 Bedford, MA | 4 days onsite (required)

Why This Role

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 Role

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.

Key Responsibilities

• 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

What We’re Looking For

Required

• 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

Preferred

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

Work Model

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

Who This Role Is For

✔ Senior QEs who enjoy upstream design quality work

✔ Those who want real influence in product development

✔ Engineers who value collaboration over bureaucracy

Who This Role Is Not Fo

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

✖ Narrow CAPA/NCR‑only positions

How to Apply

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

Seniority level

• Mid‑Senior level

Employment type

• Full‑time

Job function

• Quality Assurance and Engineering

Industries

• Medical Equipment Manufacturing and Engineering Services