> Markdown version of [/jobs/ext/2637797-ingenyx-design-quality-assurance-engineer-ii](https://www.wearedevelopers.com/jobs/ext/2637797-ingenyx-design-quality-assurance-engineer-ii). Every page supports `.md` or `Accept: text/markdown`. Links point to the HTML versions so they work for humans too. Agent guide: [/agents.md](https://www.wearedevelopers.com/agents.md).

---

# INGENYX- Design Quality Assurance Engineer II

- **Company:** Teleflex
- **Location:** Mansfield, MA, United States
- **Experience:** Experienced
- **Salary:** $87,400.0 - $131,100.0
- **Contract:** Permanent contract
- **Skills:** Iq/oq/pq, Mdsap
- **Published:** August 7, 2026
- **Apply:** https://www.careerjet.com/job/us4cd548253662e4b317a069619f60daed/eaa

## About the Role

* Bachelor's degree in Engineering or related technical field (Mechanical, Biomedical, Electrical, etc.).
 * 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, ISO 14971.

Specialized Skills / Other Requirements

 * Experience supporting Class II/III medical devices.
 * Direct involvement in FDA inspections, Notified Body audits, or MDSAP audits.
 * ASQ certifications (CQE, CQA) or equivalent preferred.
 * Strong analytical and critical thinking skills.
 * Excellent written and verbal communication.
 * Ability to influence cross-functional teams without direct authority.
 * High attention to detail with strong documentation skills.
 * Ability to manage multiple projects in a fast-paced environment.

## Description

The Design Quality Assurance (DQA) Engineer is responsible for ensuring 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).
This role partners closely with R&D, Manufacturing, Regulatory Affairs, and Program Management to ensure design control compliance, effective risk management, and successful product development from concept through commercialization.
Principal 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), 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: Hazard analysis, Risk assessments and mitigations, Risk-benefit analysis.
 * Review and approve design verification and validation protocols and reports.
 * Ensure test methods are scientifically sound and compliant with regulatory expectations.
 * Evaluate statistical justifications for sample sizes and acceptance criteria.
 * Ensure alignment of validation activities with intended use and user needs.
 * Ensure appropriate design change control processes are followed, including re-verification/re-validation as required.
 * Assess 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 (IQ/OQ/PQ alignment with design intent).
 * Support internal and external audits (FDA, Notified Body, MDSAP) related to design controls.
 * Act as SME for design quality systems during inspections.
 * Analyze design-related quality metrics (e.g., complaints, CAPAs, field issues).
 * Support CAPA investigations related to design deficiencies.


## Related Videos

- [From Bedside Beeps to Interoperable Bytes – Getting your medical devices ready to talk the IEEE 11073 language](https://www.wearedevelopers.com/videos/771-from-bedside-beeps-to-interoperable-bytes-getting-your-medical-devices-ready-to-talk-the-ieee-11073-language)
- [More efficient software for more efficient microchips](https://www.wearedevelopers.com/videos/1164-more-efficient-software-for-more-efficient-microchips)
- [Self-service Quality: QA Without QA](https://www.wearedevelopers.com/videos/100184-self-service-quality-qa-without-qa)

## Related Articles

- [How We Built a Worry-Free System That Runs for 10+ Years – And What We’d Do Again](https://www.wearedevelopers.com/magazine/751-how-we-built-a-worry-free-system-that-runs-for-10-years-and-what-we-d-do-again)
- [Fully Remote Software Engineer Jobs](https://www.wearedevelopers.com/magazine/447-fully-remote-software-engineer-jobs)
- [Why developer experience matters](https://www.wearedevelopers.com/magazine/514-why-developer-experience-matters)
- [The Biggest German Tech Companies](https://www.wearedevelopers.com/magazine/424-the-biggest-german-tech-companies)
- [How Developers Can Focus on Maintaining Satisfaction With Accessibility](https://www.wearedevelopers.com/magazine/109-how-developers-can-focus-on-maintaining-satisfaction-with-accessibility)
- [What is Software Engineering?](https://www.wearedevelopers.com/magazine/289-what-is-software-engineering)