Sr. Quality Engineer

Purpose

Contribute to the manufacturing of life-saving medical devices as a member of the Quality organization, primarily supporting operations at the Danvers, MA site with additional support for the Woburn, MA site. Provide Quality Engineering support across manufacturing and quality operations, including production, incoming inspection, nonconformance management, equipment and calibration, process validation, and other Quality functions.

Responsibilities

• Develop, modify, apply and maintain quality evaluation and control systems/protocols.
• Devise and implement methods and procedures for inspecting, testing and evaluating the precision and accuracy of products and production equipment.
• Design and analyze inspection and testing processes, mechanisms and equipment.
• Conduct quality assurance tests and perform statistical analysis to assess level of control and manage product quality risks.
• Undertake root cause analysis of incidents requiring corrective action.
• Support both the Danvers and Woburn sites.
• Document production nonconformity, conduct investigation, assess product risk, recommend disposition in collaboration with MRB.
• Define and implement action plans and effectiveness monitoring for CAPA originated from internal/external audits.
• Coach team members regarding Quality Engineering non-conformance, corrective and preventive actions through documentation, investigation, root cause analysis, and implementation.
• Ensure timely escalation of Quality Engineering issues to the next management level.
• Identify Quality Engineering non-conformance and corrective/preventive actions under limited supervision.
• Support process validations/revalidation on current and new processes (IQ, OQ, PQ).
• Support incoming inspection department as needed.
• Collaborate with equipment department for PM and calibration procedural updates.
• Support non-conformities from failed calibration.

Qualifications

• Bachelor's degree in Engineering or a related technical field and 2–4 years of relevant Quality Engineering or related experience.
• Solid understanding of IQ, OQ, PQ validation processes and GMP compliance.
• Proven track record to work independently and manage multiple tasks effectively.
• Excellent problem-solving skills and a proactive approach to challenges.
• Strong communication skills, with the ability to mentor and lead teams effectively.

Preferred

• Working knowledge of SAP.
• ASQ Certified Quality Engineer (CQE).
• Knowledge of electrical systems, schematic drawing and IPC 610.
• Experience in medical device industry working under FDA regulations (21 CFR part 820), ISO 13485 and EU MDR.
• ISO 13485 Internal audit certificate.