Sr. Quality Engineer
This position will serve as the Quality Engineering lead for the Woburn Manufacturing facility. The primary responsibilities center on resolving manufacturing issues by implementing effective solutions, revising facility documentation for accuracy and compliance, validating equipment/processes/product as needed, and identifying/implementing continuous improvement projects.
- Oversee the Material Review Board (MRB), which includes providing leadership and coordination of activities for the investigation and disposition of non-conforming product and/or components.
- Identify and resolve issues in the manufacturing of Class III PMA medical device products, by designing and conducting Quality Engineering investigations, and working directly with manufacturing engineering, operators, and other plant personnel.
- Provide technical guidance to the staff and mentorship to quality and manufacturing engineers.
- Document risk-based rationales as needed throughout the Quality Management System.
- Write and execute validations (IQ/OQ/PQ) and qualification studies as needed for new/existing equipment (inspection & process), software, components, etc.
- Manage CAPAs and Audit Action Plans to completion using risk analysis, project management, and proper effectiveness verification methods.
- Revise procedures as needed based on nonconforming material investigations, CAPA, complaints, continuous improvement projects (CIP), and compliance to local, division, and corporate procedures, in addition to local and international quality regulations.
- Represent the Quality function on committees, teams, task forces as assigned.
- Support the goals of the Quality Control Dept. and the Woburn Manufacturing facility.
- Special projects as assigned.
- Bachelor's Degree in technical area.
- Master's Degree preferred.
- Minimum 5 years within medical device industry, preferably in Class II/III manufacturing environment.
- High level of competence in Quality Technology including statistical techniques, control charts, sampling plans, process capability, process/equipment validation, Gage R&R, design of experiments, correlation and regression, analysis of variance, probability, etc.
- ASQ Certified Quality Engineer and/or Six Sigma Black Belt strongly preferred.
- Strong statistical software and MS Project skills.
- Strong oral and written communication skills.
- Ability to motivate people and mentor engineers.
- Understanding of ISO 13485, MDD/MDR, GMP, QSR, and other applicable regulations, and the ability to interpret these as they apply to company issues.
- Strong project planning skills focused on meeting customer needs.
- Proven leadership skills in a fast paced environment.