Quality Engineer

TRC Talent Solutions is seeking a Quality Engineer to support quality activities throughout the product lifecycle, including new product development, validation, commercialization, and sustaining engineering. This role partners with cross-functional teams to ensure products and processes meet quality, regulatory, and customer requirements.

Key Responsibilities:

• Support process validation activities, including PFMEA, IQ, OQ, and PQ.
• Develop and execute verification and validation protocols and reports.
• Ensure compliance with FDA regulations, ISO 13485, and other applicable standards.
• Participate in risk management activities, including ISO 14971 and Design FMEA.
• Investigate quality issues, customer complaints, and support root cause analysis.
• Review product designs for quality, reliability, and manufacturability.
• Support supplier quality and continuous improvement initiatives.

Qualifications:

• Bachelor's degree in Engineering, Life Sciences, or related field; equivalent experience considered.
• 2+ years of quality engineering experience, preferably in the medical device industry.
• Experience with process validation, risk management, statistical analysis, and quality systems.
• Familiarity with Minitab, Lean Manufacturing, and Six Sigma methodologies preferred.
• Strong communication, technical writing, and project management skills.

Physical Requirements:

• Ability to sit, stand, walk, and occasionally lift up to 50 lbs.
• Reasonable accommodations may be made for qualified individuals with disabilities.

TRC Talent Solutions is proud to be an Equal Opportunity Employer (EOE). All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, national origin, protected veteran status, disability status, sexual orientation, gender identity or expression, marital status, genetic information, or any other characteristic protected by law. At TRC, we take pride in fulfilling our opportunity to add value to our client's business as their staffing partner while connecting talented professionals with opportunities to grow their careers.