Sr. Quality Engineer

Locations: Danvers, MA and Woburn, MA.

About the role

We are searching for the best talent for a Sr. Quality Engineer, located in Danvers, MA or Woburn, MA. A pre-identified candidate for consideration has been identified; however, all applications will be considered.

In this role, you will have the unique opportunity to contribute to the manufacturing of life-saving medical devices. As part of our "Patients First!" culture, you will play a crucial role in ensuring that high standards of product quality, compliance, and patient safety are maintained. This individual will be a member of the Quality organization, primarily supporting operations at the Danvers, MA site, with additional support for the Woburn, MA site. The Sr. Quality Engineer will provide Quality Engineering support across manufacturing and quality operations, including areas such as production, incoming inspection, nonconformance management, equipment and calibration, process validation, and other Quality functions as business needs and priorities require. The successful candidate must be comfortable working across functional boundaries and adapting responsibilities to support changing operational and Quality priorities.

Responsibilities

• Developing, modifying, applying and maintaining quality evaluation and control systems/protocols.
• Devises and implements methods and procedures for inspecting, testing and evaluating the precision and accuracy of products and production equipment.
• Designs and analyzes inspection and testing processes, mechanisms and equipment.
• Conducts quality assurance tests and performs statistical analysis to assess the level of control and manage product quality risks.
• Undertakes root cause analysis of incidents requiring corrective action.
• Document production nonconformity, conduct investigation, assess product risk, recommend disposition in collaboration with other members of MRB.
• Define and implement action plans and effectiveness monitoring for CAPA originated from internal/external audits.
• Coaches team members regarding any Quality Engineering non-conformance, subsequent corrective, and preventive actions, by documenting, investigating, and conducting root cause analysis, and successfully implementing corrective actions.
• Ensures timely escalation of any Quality Engineering issues or concerns to the next management level.
• Identifies, under limited supervision, any Quality Engineering non-conformance, subsequent corrective, and preventive actions, by documenting, investigating, and conducting root cause analysis, and successfully implementing corrective actions.
• 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