Senior Quality Engineer

barrywehmiller; Flagstaff (AZ); On-site; USD 90,000 - 120,000; Full time

Job summary

Machine Solutions is seeking a Senior Quality Engineer to partner with Manufacturing, Engineering, Supply Chain, and Operations to improve product quality and reduce risk. You will lead RCCA investigations and CAPA activities while supporting MRB and supplier-related processes.

The role requires a Bachelor's degree in a technical field and at least five years in manufacturing quality engineering, with experience in AS9100/ISO standards and regulatory expectations.

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.

Responsibilities

• Lead RCCA investigations using 8D, 5-Why, Fishbone, and other structured methodologies.
• Facilitate and manage CAPA activities with timely implementation and verification.
• Support MRB activities, including disposition of nonconforming material.
• Manage supplier quality performance, supplier audits, and SCARs.
• Implement preventive actions to reduce defects, scrap, rework, and recurring quality issues.
• Support internal, customer, and third-party audits.
• Train, mentor, and develop team members.

Skills

RCCA investigations

CAPA management

MRB support

Supplier quality

Internal audits

Team mentoring

Drawing interpretation

Education

Engineering degree

Job description

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 Environment:

The physical demands for this role include standing for extended periods, frequent walking, and performing repetitive motions such as bending, lifting, and reaching. There may be times that involve prolonged periods of sitting at a desk, using a computer, and engaging in repetitive hand movements for tasks like typing or writing. Team members must be able to lift and move objects up to 50 pounds regularly and occasionally heavier items with assistance. The role may involve operating machinery, using hand tools, and maintaining precise hand-eye coordination. Good hearing and manual dexterity are essential for safely performing tasks and ensuring product quality. To effectively complete the tasks in this position, the vision requirements needed are the ability to adjust focus and identify and distinguish colors. The work environment for this role is in a manufacturing facility with machinery, tools, and materials, requiring adherence to safety protocols and the use of personal protective equipment (PPE). Noise levels can be high, and tasks may involve lifting or moving parts. Minimal time will be spent in wet or humid conditions, and near caustic or toxic chemicals.

Equal Opportunity:

Machine Solutions is a