Senior Quality Engineer
About The Position
The Senior Quality Engineer partners with Manufacturing, Engineering, Supply Chain, and Operations to improve product quality, reduce risk, and advance operational excellence. The role supports high-reliability product manufacturing and continuous improvement at Machine Solutions, a provider of equipment and services for the medical device, biopharmaceutical, and blood- and plasma-collection industries. The position works in a manufacturing facility with machinery, tools, and materials. It requires adherence to safety protocols and use of personal protective equipment. Noise levels can be high; the role involves minimal time in wet or humid conditions and near caustic or toxic chemicals. Travel is up to 10% for audits, training, or regulatory meetings.
Requirements
- Bachelor’s degree in Engineering, Quality, Manufacturing, or a related technical discipline.
- Minimum of five years of Quality Engineering experience in a manufacturing environment.
- Demonstrated experience leading RCCA investigations and managing nonconforming material.
- Experience facilitating CAPA reviews and managing supplier corrective actions.
- Ability to interpret engineering drawings, specifications, and technical documentation.
Nice To Haves
- ASQ Certified Quality Engineer (CQE), Six Sigma Green Belt, or Black Belt certification.
- Experience with AS9100, ISO 13485, ISO 9001, and/or FDA Quality System Regulations.
- Experience with APQP, PPAP, FMEA, SPC, and Control Plans.
Responsibilities
- Lead Root Cause Corrective Action (RCCA) investigations using 8D, 5-Why, Fishbone, and other structured problem-solving methodologies.
- Facilitate and manage Corrective and Preventive Action (CAPA) activities, ensuring timely implementation and verification of corrective actions.
- Support Material Review Board (MRB) activities, including disposition of nonconforming material.
- Manage supplier quality performance, supplier audits, and Supplier Corrective Action Requests (SCARs).
- Implement preventive actions that reduce defects, scrap, rework, and recurring quality issues.
- Support internal, customer, and third-party audits.
- Train, mentor, and develop team members.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
