Western/Scott Fetzer Company
Come join a team where People make the difference! As a part of Marmon Holdings, Inc., a highly decentralized organization, we rely heavily on people with the aptitude, attitude, and entrepreneurial spirit to drive our success, and we're committed to attracting and retaining top talent.
Who We Are:
Western Enterprises, now part of the Marmon family, has been around for over 60 years. We are the go-to company for everything compressed gas-related. From your basic hose fittings to intricate manifold systems, all crafted right in Westlake, Ohio. Western Enterprises is passionate about innovation and quality, always striving to meet the diverse needs of industries worldwide. We are a company dedicated to ensuring the highest quality standards in our products and processes. Our team is committed to continuous improvement and innovation, striving to exceed customer expectations and regulatory requirements.
What You'll Do:
Develop and lead validation efforts for processes, equipment, and software.
Perform root cause analysis and develop associated corrective action plans.
Plan, execute, and oversee inspection of products to verify conformance with specifications and deliverables.
Lead Corrective Action / Preventive Action (CAPA) initiatives and Quality Issue Investigation (QII) activities.
Provide audit support for regulatory inspections, customer audits, and 3rd party audits.
Conduct internal audits in support of maintaining and improving the quality system.
Support complaint investigations and the implementation of both immediate and longer-term corrective actions.
Identify systemic corrective actions and root causes for both products and processes.
Develop and implement changes to support continuous improvement.
Develop and execute Quality Plans for new products and process development.
Maintain current industry, regulatory, and QMS expertise.
Support the development of inspection methods, equipment, and tools.
React to and mitigate risk associated with the discovery of nonconformance events.
Determine appropriate material disposition for nonconformance events.
Provide guidance, leadership, and quality oversight for inspection and assembly, execution of procedures, and general safety.
Support the development of design and process risk management activities.
Develop and deliver training for continuous improvement efforts and the execution of quality functions, such as inspection.
Identify, procure, and/or design gauging and equipment necessary for the inspection of machined parts.
What You'll Need:
Bachelor's degree in a science, engineering, or manufacturing technologies related field, or equivalent combination of education and hands-on experience.
3-5 years of quality and manufacturing-related experience preferred.
Relevant quality or manufacturing process certification preferred (Lean, Six Sigma, CQE, etc.).
Experience in a regulated environment preferred (ISO9001, ISO13485, 21 CFR 820, etc.).
Specific technical training as required.
ISO9001 or ISO13485 lead auditor certification preferred.
Knowledge of validation concepts (process/equipment/software), root cause analysis, medical device regulations, ISO9001, ISO13485, 21 CFR 820, metrology, SPC, gauge R&R, engineering prints/drawings, statistical sampling.
Familiarity with machining and related processes - turning, drilling, milling, deburring, cleaning, and plating.
Skills/Ability to develop and lead validation efforts for processes, equipment, and software. Identify, react to, and mitigate risk associated with the discovery of nonconformance events. Develop and implement changes to support continuous improvement.
A valid driver's license is needed to enable occasional travel between facilities.
What We Offer
At our company, we believe in providing a comprehensive benefits package to support the well-being and growth of our employees. Our benefits include:
- Comprehensive health insurance plans, including medical, dental, and vision coverage.
- Salary Range of: $80,000 - $100,000
- Paid time off
- Opportunities for professional growth through training and mentorship
- And much more.
Following receipt of a conditional offer of employment, candidates will be required to complete additional job-related screening processes as permitted or required by applicable law.
We are an equal opportunity employer, and all applicants will be considered for employment without attention to their membership in any protected class. If you require any reasonable accommodation to complete your application or any part of the recruiting process, please email your request to , and please be sure to include the title and the location of the position for which you are applying.