Job Summary:
The Senior Manager of Quality Engineering will lead the quality assurance efforts in the manufacturing process for medical devices, ensuring compliance with regulatory standards and internal procedures. This role is responsible for overseeing all validation activities related to equipment, processes, software, and systems in the development and manufacturing of medical devices. This role involves driving the implementation of quality initiatives, improving product quality, and maintaining high standards across the manufacturing process. The Senior Manager will collaborate closely with cross-functional teams, including manufacturing, engineering, and also with customers, to ensure products are consistently produced in compliance with FDA, ISO 13485, and other relevant standards.
Key Responsibilities:
1. Leadership & Strategy:
1) Lead and mentor the Quality Engineering teams (NPI, Mass production and Validation), providing guidance, support, and development opportunities.
2) Develop validation strategies and plans in alignment with company goals, industry regulations, and best practices.
3) Develop and implement strategies to continuously improve manufacturing quality processes and reduce non-conformances.
4) Collaborate with manufacturing and engineering teams to ensure products meet quality standards throughout the production lifecycle.
2. Manufacturing Quality Management:
1) Oversee the implementation and maintenance of quality systems, ensuring compliance with all applicable regulatory and quality standards (FDA, ISO 13485,etc.).
2) Lead quality activities during manufacturing processes, including process validations, qualification of equipment, and verification of production lines.
3) Establish and monitor key quality metrics (KPIs) to assess the effectiveness of manufacturing quality processes.
4) Implement and manage non-conformance and CAPA (Corrective and Preventive Action) processes to ensure timely resolution of issues.
3. New Product Introduction (NPI):
1) Collaborate with Customers and Engineering teams to ensure the successful transfer of new products from development to manufacturing.
2) Develop and validate processes and systems to ensure new products meet regulatory and quality requirements during scaling up for mass production.
3) Participate in Design for Manufacturing (DFM) reviews to identify potential manufacturing and quality issues early in the product development process.
4. Mass Production:
1) Manage and maintain quality systems to ensure consistent product quality during high-volume manufacturing
2) Develop and monitor key production quality metrics (KPIs) such as defect rates, ***-pass yield, and scrap rates, ensuring continuous improvement.
3) Implement process controls and risk mitigation strategies to minimize quality issues during mass production.
4) Ensure timely investigation, root cause analysis, and resolution of any production related quality issues, including non-conformance reports (NCRs) and deviations
5) Drive continuous improvement initiatives aimed at enhancing product quality and operational efficiency within the manufacturing environment.
5. Validation Management
1) Oversee the creation, execution, and approval of validation master plans, validation protocols for equipment, processes, software, and systems, ensuring alignment with regulatory and industry standards.
2) Manage Process Validation (IQ, OQ, PQ), Equipment Validation, Cleaning Validation, and Computer System Validation (CSV) activities.
3) Ensure all validation documentation is accurate, complete, and in compliance with applicable regulations, including the preparation and approval of validation plans, reports, and protocols.
4) Implement risk-based validation approaches using tools such as Failure Mode and Effects Analysis (FMEA) to ensure that critical risks are identified and mitigated.
6. Regulatory & Compliance:
1) Ensure manufacturing operations comply with all regulatory requirements, including FDA 21 CFR Part 820, ISO 13485, and other applicable standards.
2) Lead audits related to manufacturing quality processes, including internal audits and external audits (customer audits and regulatory inspections).
3) Ensure proper documentation and records management related to manufacturing quality systems.
7. Collaboration & Communication:
1) Act as the primary interface between the quality engineering team and other departments, including Supply chain, Engineering, Materials etc.
2) Provide regular updates to senior management on key quality metrics, project status, and any critical issues affecting production quality.
Qualifications:
1. Bachelor’s degree in Engineering, Life Sciences, or a related field.
2. Minimum of 10 years of experience in quality engineering within the medical device industry, with a focus on manufacturing.
3. Proven leadership experience, with at least 3-5 years of managing teams.
4. In-depth knowledge of FDA regulations, ISO 13485, and GMP requirements in medical device manufacturing.
5. Strong problem-solving skills and experience with quality tools is preferred (e.g., Six Sigma, Lean, 8D, FMEA).
6. Experience with process validation, equipment qualification, and product testing methodologies.
7. Excellent communication and collaboration skills, with the ability to work cross functionally.
8. Strong verbal and written English communication skills are required.
9. FDA / NMPA regulatory experience is preferred.