Manager - Manufacturing Quality Assurance
Manager - Manufacturing Quality Assurance
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Job Description
What will you do:
- Develop implement and maintain quality assurance policies and procedures in alignment with industry standards (e.g. ISO GMP FDA).
- Lead and supervise the QA team ensuring quality inspections audits and testing are effectively performed throughout the manufacturing process.
- Collaborate with production engineering and supply chain teams to ensure quality objectives are met and maintained.
- Manage internal and external audits nonconformance investigations and corrective/preventive action (CAPA) processes.
- Monitor production processes and outputs to identify trends and areas for improvement using tools such as SPC FMEA and root cause analysis.
- Drive continuous improvement initiatives to increase product quality reduce waste and enhance customer satisfaction.
- Oversee supplier quality processes including qualification performance evaluation and incoming inspection.
- Ensure proper documentation data integrity and compliance with company and regulatory standards.Report on quality performance metrics and provide recommendations to senior management.
What you need:
Required skills:
Bachelors degree in engineering Quality Assurance or a related technical field (Masters degree preferred).
1517 years of experience in a manufacturing quality assurance role including 57 years in a leadership or management position.
Strong knowledge of quality systems and regulatory standards (ISO 9001 ISO 13485 GMP FDA etc..
Proficiency in quality tools and methodologies such as Six Sigma Lean Manufacturing CAPA FMEA and 8D problem solving.
Excellent leadership communication and organizational skills.Experience working with quality management systems (QMS) and data analysis software.
Experience in regulated industries such as medical devices pharmaceuticals automotive or aerospace.Familiarity with ERP systems and digital quality tools.
Preferred skills:
- Certified Quality Engineer (CQE) Certified Manager of Quality/Organizational Excellence (CMQ/OE) or similar certification.
Travel Percentage: 10
Required Experience:
Manager
Employment Type
Full-Time
