Quality Leader

Quality Leader

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 Overview

The Quality Leader is a managerial/leadership role responsible for spearheading the creation, implementation, and evolution of our quality systems, driving excellence across all facets of Machine Solutions. The focus is to ensure our equipment not only meets but exceeds customer requirements while maintaining compliance with regulatory standards and meeting customer delivery expectations. This role is at the forefront of cultivating a culture of quality, inspiring teams, and leading initiatives that ensure consistency, compliance, and continuous improvement. Problems are typically difficult and non-routine, receiving moderate guidance, direction, and oversight from senior manager or director.

Essential Duties and Responsibilities

• Drives Innovation: Designs and implements a cutting-edge quality management system tailored to meet and exceed customer expectations.
• Leads by Example: Leads, directs, and oversees the day-to-day operations of the Quality Department across multiple locations, ensuring alignment and high performance.
• Inspires Collaboration: Partners with cross-functional teams to solve complex challenges, introduce new products, and set quality benchmarks for internal and external processes.
• Fosters Improvement: Leads efforts in root cause analysis, corrective action implementation, and continuous improvement initiatives that elevate our products and processes.
• Champions Compliance: Ensures adherence to all internal and external quality standards (ISO, customer requirements, etc.), while maintaining transparent and robust documentation.
• Empowers Teams: Builds and mentors a high-performing quality team, providing training and development opportunities that elevate skillsets and drive results.
• Delivers Excellence: Tracks, analyzes, and presents key performance indicators (KPIs) to guide decisions and foster accountability.
• Additional duties as required.

Qualifications

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

The Quality Leader must be able to perform the duties of a Quality Systems Specialist, and/or Quality Control Specialist, satisfactorily.

Education and/or Experience

• Bachelor's degree in quality management, Business Administration, Information Management, or a related field preferred.
• 5-10 years of experience in a Quality Assurance position; experience in manufacturing equipment strongly preferred.

Knowledge, Skills, and Abilities

• Strong understanding and application of Lean Six Sigma & Continuous Improvement methodologies.
• Proven experience in managing Continuous Improvement projects.
• High proficiency in quality management or a similar leadership role.
• High level of strategic thinking thriving in collaborative, fast-paced environments.
• Strong knowledge of quality standards and compliance requirements (ISO, regulatory agencies, etc.).
• Proven experience in inspiring and leading teams, driving change, and embodies a commitment to continuous improvement.
• Works independently with moderate supervision and applies practical knowledge to problems; continues to build knowledge of organization, practices, procedures.

Travel

• Up to 10% for audits, training, or regulatory meetings.

Physical Demands & Work Environment

This role is office-based with occasional exposure to manufacturing environments. 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. Employees 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 vision, hearing, and manual dexterity are essential for safely performing tasks and ensuring product quality. 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.

Barry-Wehmiller is an equal opportunity employer. M/F/D/V This organization uses E-Verify. Applicants may be subject to pre-employment screening which may include drug screening, reference checks, employment verifications, background screening and/or skills assessments.

Company: Machine Solutions, Inc.