INGENYX- Design Quality Assurance Engineer II

Teleflex•Mansfield, MA

1d•$87,400 - $110,000

About The Position

The Design Quality Assurance (DQA) Engineer ensures that product design and development activities comply with applicable regulatory and quality requirements, including ISO 13485, EU MDR (2017/745), MDSAP, and FDA 21 CFR Part 820 (QSR). The role partners with R&D, Manufacturing, Regulatory Affairs, and Program Management to support design control compliance, effective risk management, and product development from concept through commercialization. The position provides quality oversight throughout the product lifecycle, supports design reviews and design control documentation, and oversees risk management, verification and validation, change control, and design transfer. It also supports audits and inspections, design-related quality investigations and metrics, and collaboration with Manufacturing and Process Engineering on validation strategies.

Requirements

Bachelor’s degree in Engineering or a related technical field, such as Mechanical, Biomedical, or Electrical Engineering.
Minimum 2–5 years of experience in medical device quality or design assurance.
Knowledge of ISO 13485, FDA 21 CFR Part 820 (QSR), EU MDR, MDSAP, and ISO 14971.
Strong analytical and critical thinking skills.
Excellent written and verbal communication skills.
Ability to influence cross-functional teams without direct authority.
High attention to detail and strong documentation skills.
Ability to manage multiple projects in a fast-paced environment.

Nice To Haves

Experience supporting Class II/III medical devices.
Direct involvement in FDA inspections, Notified Body audits, or MDSAP audits.
ASQ certifications (CQE, CQA) or equivalent.

Responsibilities

Ensure compliance with Design Controls (21 CFR 820.30) and ISO 13485 design and development requirements.
Provide quality oversight for design and development activities throughout the product lifecycle.
Participate in and approve design reviews, ensuring deliverables meet regulatory and internal quality standards.
Ensure completeness and compliance of Design History Files (DHF).
Lead and support design control deliverables, including design and development plans, design inputs and outputs, design verification and validation (DV&V), and design transfer.
Ensure robust traceability matrices linking user needs, design inputs, outputs, verification, and validation.
Facilitate and review risk management activities in accordance with ISO 14971, including hazard analysis, risk assessments and mitigations, and risk-benefit analysis.
Review and approve design verification and validation protocols and reports.
Ensure test methods are scientifically sound and comply with regulatory expectations.
Evaluate statistical justifications for sample sizes and acceptance criteria.
Ensure validation activities align with intended use and user needs.
Ensure appropriate design change control processes are followed, including re-verification or re-validation as required.
Assess the impact of changes on regulatory submissions and product risk.
Ensure smooth design transfer to manufacturing with complete and compliant documentation.
Review Device Master Record (DMR) elements for accuracy and completeness.
Partner with Manufacturing and Process Engineering on validation strategies, including IQ/OQ/PQ alignment with design intent.
Support internal and external audits related to design controls, including FDA, Notified Body, and MDSAP audits.
Act as a subject matter expert for design quality systems during inspections.
Analyze design-related quality metrics, such as complaints, CAPAs, and field issues.
Support CAPA investigations related to design deficiencies.