What are the responsibilities and job description for the Senior Quality Engineer position at Pragmatic?
Medical Device | Design Controls | Risk Management | FDA / ISO / EU MDR
đź“Ť 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
- ASQ certifications (CQE, CQA, Biomedical Auditor, etc.)
- 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
âś” Senior QEs who enjoy upstream design quality work
âś” Those who want real influence in product development
âś” Engineers who value collaboration over bureaucracy
Who This Role Is Not For
âś– Manufacturing-only or shop-floor-focused Quality roles
âś– 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.
Salary : $120,000 - $140,000