Sr. Quality Engineer Position Available In Bristol, Massachusetts

Make a Difference in

Patient Lives:

Sr. Quality Engineer – Medical Devices Are you a seasoned Quality Engineer with a passion for medical devices and a drive for continuous improvement? Do you thrive in a collaborative environment where your expertise can directly impact product quality and patient safety? If so, we want you on our team in Mansfield, MA! We’re a leading medical device company seeking a Sr. Quality Engineer to play a critical role in ensuring the highest standards of quality throughout our product lifecycle. In this role, you’ll leverage your strong mechanical engineering background and deep understanding of quality engineering principles to support the development, transfer, and maintenance of our innovative products.

What You’ll Do:

Champion Quality:

Utilize your Quality Engineering tools and practices to drive effective and efficient product/process development, transfer, and maintenance.

Manage Non-Conformances:

Expertly manage non-conforming material reports in our electronic-based system, working with third-party suppliers to resolve issues.

Drive Continuous Improvement:

Support quality improvement initiatives, conduct thorough process and product characterizations, and implement appropriate process monitoring and control methods.

Ensure Compliance:

Conduct internal and supplier audits per ISO-13485 and 21 CFR 820, and ensure adherence to our high standards.

Investigate and Solve:

Lead investigations into accidents, injuries, and near-miss incidents, perform root cause analyses, and develop corrective actions. Be a

Leader:

Supervise, lead, and mentor other engineers and technicians, fostering a culture of excellence.

What You’ll Bring:

Bachelor’s degree in Mechanical Engineering (or equivalent) 5-8 years of Quality Engineering experience in the medical device industry In-depth knowledge of product/process Risk Management (FDA and ISO standards) Proven ability to manage non-conforming material reports in an electronic-based system Certified Internal Auditor to

ISO-13485

Strong problem-solving, analytical, and communication skills Ability to work independently and collaboratively with multiple teams Ability to walk throughout our facility Why Join Us? Be part of a company that is making a real difference in patient lives Work in a dynamic and collaborative environment Opportunity to lead and mentor other engineers

Location:

Mansfield, MA (Onsite – 12+ months) Ready to take the next step in your career? Apply now and help us deliver life-changing medical devices to patients around the world! 9881087