Synergy Talent Solutions LLC
Synergy Talent Solutions LLC provided pay range
This range is provided by Synergy Talent Solutions LLC. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.
Base pay range $110,000.00/yr - $125,000.00/yr
Direct message the job poster from Synergy Talent Solutions LLC.
Our client located in the Germantown/Menomonee Falls area is seeking an experienced and proactive Quality Manager to lead the Quality functions at their tooling facility. In this role you will play a key part in advancing FOT to FAT (First-Off Tool to Final Acceptance Testing) capabilities, strengthening the client’s quality systems, and supporting their continued growth of their tooling and production operations.
Duties and Responsibilities
Maintain and improve the Quality Management System (QMS) in accordance with ISO 9001, internal client procedures, customer-specific requirements, and applicable regulatory standards.
Support compliance efforts related to ISO 13485 and 21 CFR Part 820 for medical device manufacturing, ensuring alignment with regulatory expectations for documentation, process control, and traceability.
Ensure readiness for and assist in internal, second-party, and third-party audits, including effective response and implementation of corrective actions for audit findings.
Conduct Layered Process Audits and support ongoing quality assurance activities within cleanroom and non-cleanroom environments.
Maintain understanding of cleanroom protocols, gowning practices, and cleanliness requirements to support manufacturing in controlled environments.
Ensure proper interpretation and application of medical customer-specific requirements, supporting consistent delivery of compliant and high‑quality products.
Provide mentorship; support and direction for the Quality and Metrology team.
Conduct performance evaluations, identify development opportunities, and address skill gaps.
Collaborate with HR on team planning aligned with business needs.
Foster a professional, accountable, and safety‑focused team culture.
Any other duties as assigned.
Experience and Skills
Bachelor’s degree in Engineering, Manufacturing, Quality, or related field is preferred.
Ideally a minimum of 8+ years of experience in Quality, or equivalent combination of education and experience is preferred.
Demonstrated experience in problem solving.
Demonstrated statistical analysis skills.
Strong knowledge of ISO 9001 and familiarity with ISO 13485 is a plus.
Experience in working with teams to achieve results.
Seniority level Mid‑Senior level
Employment type Full‑time
Job function Management and Quality Assurance
Industries Plastics Manufacturing
Benefits
Medical insurance
401(k)
Vision insurance
#J-18808-Ljbffr
Base pay range $110,000.00/yr - $125,000.00/yr
Direct message the job poster from Synergy Talent Solutions LLC.
Our client located in the Germantown/Menomonee Falls area is seeking an experienced and proactive Quality Manager to lead the Quality functions at their tooling facility. In this role you will play a key part in advancing FOT to FAT (First-Off Tool to Final Acceptance Testing) capabilities, strengthening the client’s quality systems, and supporting their continued growth of their tooling and production operations.
Duties and Responsibilities
Maintain and improve the Quality Management System (QMS) in accordance with ISO 9001, internal client procedures, customer-specific requirements, and applicable regulatory standards.
Support compliance efforts related to ISO 13485 and 21 CFR Part 820 for medical device manufacturing, ensuring alignment with regulatory expectations for documentation, process control, and traceability.
Ensure readiness for and assist in internal, second-party, and third-party audits, including effective response and implementation of corrective actions for audit findings.
Conduct Layered Process Audits and support ongoing quality assurance activities within cleanroom and non-cleanroom environments.
Maintain understanding of cleanroom protocols, gowning practices, and cleanliness requirements to support manufacturing in controlled environments.
Ensure proper interpretation and application of medical customer-specific requirements, supporting consistent delivery of compliant and high‑quality products.
Provide mentorship; support and direction for the Quality and Metrology team.
Conduct performance evaluations, identify development opportunities, and address skill gaps.
Collaborate with HR on team planning aligned with business needs.
Foster a professional, accountable, and safety‑focused team culture.
Any other duties as assigned.
Experience and Skills
Bachelor’s degree in Engineering, Manufacturing, Quality, or related field is preferred.
Ideally a minimum of 8+ years of experience in Quality, or equivalent combination of education and experience is preferred.
Demonstrated experience in problem solving.
Demonstrated statistical analysis skills.
Strong knowledge of ISO 9001 and familiarity with ISO 13485 is a plus.
Experience in working with teams to achieve results.
Seniority level Mid‑Senior level
Employment type Full‑time
Job function Management and Quality Assurance
Industries Plastics Manufacturing
Benefits
Medical insurance
401(k)
Vision insurance
#J-18808-Ljbffr