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.

• Ability to sit, stand, walk, and occasionally lift up to 50 lbs.

• Reasonable accommodations may be made for qualified individuals with disabilities.