Senior Quality Engineer

About Us:

Machine Solutions is the premier provider of advanced equipment and services for the medical device, biopharmaceutical, and blood- and plasma-collection industries. We support our customers’ needs and growth by delivering quality and value through a wide breadth of products. Machine Solutions provides proprietary mechanical solutions to a variety of complex process, testing and device design challenges. Our equipment has become the industry standard for stent crimping, balloon catheter pleating and folding, catheter braiding and medical device manufacturing applications.

As a pioneer in radio frequency technology, the company has continued to develop advancing technology for thermal forming, molding and welding plastic for medical manufacturing, biopharmaceutical, and blood- and plasma-processing applications. Our experienced team of engineers has been instrumental in automating manual processes that enable our customers to increase production volumes and profit margins, and we believe in providing a superior customer experience by designating resources to a dedicated aftermarket team that is always ready to provide technical service and process support.

Machine Solutions is privately owned by BW Forsyth Partners, a Barry-Wehmiller company.

BW Forsyth Partners is the investment arm of multibillion-dollar global manufacturing and engineering consulting firm Barry-Wehmiller. Established in 2009, BW Forsyth Partners blends Barry-Wehmiller’s unparalleled legacy of value creation and people-centric culture development with keen investing experience to help companies realize their true potential. With a focus limited to areas known well, BW Forsyth Partners seeks to partner with leadership teams to acquire small- to middle-market companies in the capital and component equipment, and professional services sectors.

In each of our operating companies, BW Forsyth Partners deploys operational improvements and strategy development without compromising the autonomy, strategic vision and entrepreneurial spirit of their leadership teams.

Job Description:

Position Overview The Senior Quality Engineer partners with Manufacturing, Engineering, Supply Chain, and Operations to improve product quality, reduce risk, and advance operational excellence.

Key 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

Required Qualifications 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

Preferred Qualifications ASQ Certified Quality Engineer (CQE) or 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 Travel:
Up to 10% for audits, training, or regulatory meetings

Physical Demand & Work…