Work Location: Middlesex County, Massachusetts

Summary:

Seeking a Quality Engineering professional to support both new product development and ongoing product maintenance within a regulated manufacturing environment. The role requires hands-on involvement in quality systems, process improvement, and cross-functional collaboration.

Responsibilities:

• Lead efforts to identify, monitor, and report non-conformances, implementing corrective actions and process improvements to prevent recurrence.
• Chair the Material Review Board (MRB) process, ensuring timely and effective resolution of quality issues.
• Deliver training and guidance to manufacturing and quality control teams to enhance quality assurance and process control.
• Oversee customer complaint and Return Material Authorization (RMA) processes, ensuring thorough investigation and resolution.
• Serve as the primary contact for customer risk management activities, including PPAP programs, PFMEA, and Control Plans.
• Participate in Gage R&R studies and validation activities such as IQ/OQ/PQ to support process and product quality.
• Collaborate with engineering teams on the development and documentation of new processes and engineering change orders.
• Maintain and create Device History Records, conduct internal audits per ISO 13485, and manage CAPA processes for both internal and external non-conformances.

Qualifications:

• Bachelor’s degree in Mechanical, Manufacturing, or Biomedical Engineering.
• 3-5 years of experience in medical device manufacturing.
• Experience with ISO 13485 standards and internal auditing (training preferred).
• Proficiency with Minitab data analysis software.
• Strong skills in Microsoft Office suite.
• Ability to work effectively in a small team environment and adapt to multiple roles as needed.
• Comfortable managing multiple priorities and working in a dynamic, hands-on setting.
• Excellent communication and problem-solving skills.

Published Category: Quality & Validation