Quality Engineer - Medical Device - Yonkers, NY

Are you a Quality Engineer in the Medical Device Manufacturing industry or a related industry with 3+ years of experience? Do you have experience with audits, corrective actions, and ISO 13485? Do you have a degree in engineering or a related field? Do you want to join a growing company? If so, please read on and apply to the Quality Engineer - Medical Device job opening near Yonkers, NY.

Client Details

We are currently partnered up with a growing Medical Device Manufacturing Company in their search for a Quality Engineer to join the team due to growth. This position will report into the Quality Manager and will work at the 350+ employee site on a team of strong quality professionals. The ideal candidate will have 3+ years of experience in a highly regulated industry. If interested, please read on and apply to the Quality Engineer - Medical Device Job based near Yonkers, NY.

Description

The Quality Engineer - Medical Device Manufacturing will be responsible for the following:

• Develop, implement, and maintain quality processes and documentation in compliance with FDA 21 CFR Part 820 and ISO 13485
• Perform and document investigations of non-conformances (NCRs), CAPAs, and customer complaints
• Support validation activities including protocol development and execution for IQ, OQ, and PQ
• Lead root cause analysis and implement corrective/preventive actions for process or product issues
• Conduct internal audits and support external audits from regulatory bodies and customers
• Participate in risk management activities (e.g., FMEA, risk assessments) throughout product lifecycle
• Review and approve change control documentation, specifications, and quality records
• Collaborate with engineering, production, and regulatory teams to ensure design transfer and production controls meet quality requirements
• Perform data analysis and generate quality metrics to identify trends and drive continuous improvement
• Ensure proper calibration and maintenance of inspection equipment and measuring tools
• Support supplier quality initiatives, including audits and material inspection reviews

Profile

The ideal Quality Engineer - Medical Device Manufacturing will have the following qualifications:

• Bachelor's degree in Engineering, Life Sciences, or a related technical field
• 2-5 years of quality engineering experience in the medical device or pharmaceutical industry
• Solid understanding of FDA regulations (21 CFR 820), ISO 13485, and risk management principles (ISO 14971)
• Experience with CAPA, validation, root cause analysis, and quality documentation
• Ability to interpret engineering drawings and specifications (GD&T knowledge preferred)
• Strong communication, analytical, and problem-solving skills
• Proficiency with Microsoft Office and QMS tools
• Certified Quality Engineer (CQE), Certified Biomedical Auditor (CBA), or Six Sigma certification
• Experience with electronic QMS platforms (e.g., MasterControl, Greenlight Guru, ETQ)
• Familiarity with EU MDR, MDSAP, or other global regulatory requirements
• Knowledge of cleanroom manufacturing and GMP practices

Job Offer

The successful Quality Engineer - Medical Device Manufacturing will be rewarded with the following:

• Base Salary of $70,000-$110,000 depending on experience
• Bonus
• PTO
• 401K Match
• Medical, Dental, Vision

MPI does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity or expression, national origin, age, disability, veteran status, marital status, or based on an individual's status in any group or class protected by applicable federal, state or local law. MPI encourages applications from minorities, women, the disabled, protected veterans and all other qualified applicants.