Sr. Quality Engineer

We are seeking a highly experienced and collaborative Senior Quality Engineer to join our client'sQuality team. This role will be instrumental in leading risk management activities, supporting new product introductions (NPIs), and sustaining engineering efforts for primarily Class I and II medical devices marketed in the US. The ideal candidate will bring experience in ISO 13485, ISO 14971, design control, validations, and quality systems, with a strong preference for experience in EU MDR technical documentation.

Key Responsibilities

· Own the creation, maintenance, and continuous improvement of Risk Management Files in accordance with ISO 14971.

· Facilitate cross-functional risk assessments throughout the product lifecycle.

· Partner with R&D to ensure quality is built into the design and development of new products.

· Provide quality engineering support for design changes, product updates, supplier diversification, and post-market surveillance.

· Provide process and test method validation expertise to suppliers and internal teams.

· Ensure compliance with ISO 13485, FDA QSR, and internal quality system requirements.

· Support internal and external audits.

· Lead or support internal investigations, including CAPA and nonconformances.

· Mentor and provide technical guidance across teams.

· Foster a culture of quality, continuous improvement, and cross-functional collaboration.

$85,000 to $100,000 - Exact compensation may vary based on several factors, including skills, experience, and education.

We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment regardless of their race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to HR@insightglobal.com.To learn more about how we collect, keep, and process your private information, please review Insight Global's Workforce Privacy Policy: https://insightglobal.com/workforce-privacy-policy/.

· Bachelor’s degree in engineering, life sciences, or related technical discipline.

· 5+ years of experience in quality engineering, product development, or manufacturing with the medical device industry.

· Demonstrated experience with leading risk management and design control activities.

· Solid understanding of statistical methods used in capability analysis, trend analysis, sampling plans, and data interpretation.

· Strong knowledge of ISO 13485, ISO 14971, and FDA 21 CFR Part 820.

· Familiarity with Class I medical devices and U.S. market requirements

· Proven ability to mentor cross-functional teams and drive quality initiatives.

· Excellent communication, problem-solving, and organizational skills.

Preferred Qualifications

· Master’s degree or advanced certification (e.g., ASQ CQE, CQA).

· Experience with EU MDR technical documentation and regulatory submissions.

Benefit packages for this role will start on the 1st day of employment and include medical, dental, and vision insurance, as well as HSA, FSA, and DCFSA account options, and 401k retirement account access with employer matching. Employees in this role are also entitled to paid sick leave and/or other paid time off as provided by applicable law.