Supplier Quality Manager-Torrance, CA bei Prime Matter Labs
Prime Matter Labs · Torrance, Vereinigte Staaten Von Amerika · Onsite
- Professional
- Optionales Büro in Torrance
Essential Duties and Responsibilities:
Includes the following. Other duties may be assigned.
Performs all tasks and assignments in a safe and timely manner.
Strives toward continuous self-improvement in personal productivity.
Develop and maintain supplier quality assurance programs aligned with FDA, ISO 22716 (GMP for cosmetics), and other applicable regulations.
Conduct supplier audits, assessments, and risk evaluations to ensure compliance with quality standards.
Collaborate with Supply Chain, R&D, Quality and Regulatory Affairs to qualify new suppliers and manage ongoing supplier performance.
Lead investigations into supplier-related non-conformances and drive corrective and preventive actions (CAPA).
Monitor and report supplier KPIs including defect rates, delivery quality, and responsiveness.
Implement and manage supplier scorecards and continuous improvement initiatives.
Ensure proper documentation and traceability of supplier quality records.
Stay current with industry trends, regulatory changes, and emerging risks in the OTC/cosmetics supply chain.
Collaborate with cross-functional teams to support continuous improvement initiatives.
Develop, Review, Write, and Implement SOP's for quality functions and ensure compliance with all regulatory and GMP requirements.
Demonstrated leadership and management skills, including establishing direction and goals, and building good work ethics for the team. Reviews subordinate performance in a formal review process.
Support audit preparedness and internal audit programs, as well as regulatory and customer audit inspection readiness.
Preferred:
ASQ Certified Quality Engineer (CQE), ASQ Certified Quality Auditor (CQA), ISO 13485 Lead Auditor Certification.
Demonstrated leadership and management skills, including establishing direction and goals, and building good work ethics for the team.
Willingness to travel to company and vendor facilities as needed, approximately 25%.
qualifications:
Minimum 5 years of relevant experience in engineering, quality assurance, or manufacturing supplier quality in regulated manufacturing environment (cosmetics or OTC drugs a plus).
Bachelor’s degree in a scientific or technical field (e.g., Chemistry, Biology, Pharmaceutical Sciences).
Working knowledge of Six Sigma and/or Lean Manufacturing principles.
Working knowledge of quality systems and regulatory requirements (21 CFR Part 11/ 210/ 211), including data integrity and practices.
Proficiency in quality tools and methodologies, including Supplier Assessments, First Article Inspections (FAI), Failure Modes and Effects Analysis (FMEA), 8D Problem Solving, Root Cause Analysis, Corrective and Preventive Actions (CAPA), Mistake Proofing and Process Control.
Exceptional problem-solving skills, attention to detail, and the ability to manage multiple priorities in a fast-paced environment.
Strong attention to detail and organizational skills.
Effective written and verbal communication skills.
Proficiency in Microsoft Office and familiarity with electronic quality systems.
Adheres to all Prime Personnel Policies as established by the company.
Physical Requirements:
Salary Range: $90,000.00 to $110,000.00
At Prime, we believe that a diverse, equitable and inclusive workplace makes us a more relevant, more competitive, and more resilient company. We welcome people from all backgrounds, ethnicities, cultures, and experiences. Prime is an equal opportunity employer.
Jetzt bewerben
Includes the following. Other duties may be assigned.
Performs all tasks and assignments in a safe and timely manner.
Strives toward continuous self-improvement in personal productivity.
Develop and maintain supplier quality assurance programs aligned with FDA, ISO 22716 (GMP for cosmetics), and other applicable regulations.
Conduct supplier audits, assessments, and risk evaluations to ensure compliance with quality standards.
Collaborate with Supply Chain, R&D, Quality and Regulatory Affairs to qualify new suppliers and manage ongoing supplier performance.
Lead investigations into supplier-related non-conformances and drive corrective and preventive actions (CAPA).
Monitor and report supplier KPIs including defect rates, delivery quality, and responsiveness.
Implement and manage supplier scorecards and continuous improvement initiatives.
Ensure proper documentation and traceability of supplier quality records.
Stay current with industry trends, regulatory changes, and emerging risks in the OTC/cosmetics supply chain.
Collaborate with cross-functional teams to support continuous improvement initiatives.
Develop, Review, Write, and Implement SOP's for quality functions and ensure compliance with all regulatory and GMP requirements.
Demonstrated leadership and management skills, including establishing direction and goals, and building good work ethics for the team. Reviews subordinate performance in a formal review process.
Support audit preparedness and internal audit programs, as well as regulatory and customer audit inspection readiness.
Preferred:
ASQ Certified Quality Engineer (CQE), ASQ Certified Quality Auditor (CQA), ISO 13485 Lead Auditor Certification.
Demonstrated leadership and management skills, including establishing direction and goals, and building good work ethics for the team.
Willingness to travel to company and vendor facilities as needed, approximately 25%.
qualifications:
Minimum 5 years of relevant experience in engineering, quality assurance, or manufacturing supplier quality in regulated manufacturing environment (cosmetics or OTC drugs a plus).
Bachelor’s degree in a scientific or technical field (e.g., Chemistry, Biology, Pharmaceutical Sciences).
Working knowledge of Six Sigma and/or Lean Manufacturing principles.
Working knowledge of quality systems and regulatory requirements (21 CFR Part 11/ 210/ 211), including data integrity and practices.
Proficiency in quality tools and methodologies, including Supplier Assessments, First Article Inspections (FAI), Failure Modes and Effects Analysis (FMEA), 8D Problem Solving, Root Cause Analysis, Corrective and Preventive Actions (CAPA), Mistake Proofing and Process Control.
Exceptional problem-solving skills, attention to detail, and the ability to manage multiple priorities in a fast-paced environment.
Strong attention to detail and organizational skills.
Effective written and verbal communication skills.
Proficiency in Microsoft Office and familiarity with electronic quality systems.
Adheres to all Prime Personnel Policies as established by the company.
Physical Requirements:
- Ability to lift and move objects weighing up to 25 pounds regularly and occasionally heavier items with assistance.
- Ability to stand, walk, bend, stoop, push, and pull for extended periods during shifts.
- Good understanding of safety protocols and practices.
- Willingness to work flexible hours, including shifts and weekends.
- Ability to work in a fast-paced environment and adapt to changing priorities.
Salary Range: $90,000.00 to $110,000.00
At Prime, we believe that a diverse, equitable and inclusive workplace makes us a more relevant, more competitive, and more resilient company. We welcome people from all backgrounds, ethnicities, cultures, and experiences. Prime is an equal opportunity employer.
Jetzt bewerben
