Bachelor's degree in Engineering from an accredited institution.
Minimum of 8 years of relevant professional experience.
Experience in the Medical Device industry is essential.
ISO 13485 Lead Auditor certification required.
Strong familiarity with Medical Device Regulations and quality standards including cGMP, CFR 820, ISO 13485, ISO 14971, and ISO 9001.
Proficient in risk management practices and CAPA, IQ/OQ/PQ validation methodologies.
Knowledge of project management techniques and international regulatory frameworks.
Responsibilities
Conduct thorough technical reviews of suppliers' manufacturing capabilities.
Monitor and evaluate supplier manufacturing processes and quality control systems.
Define and approve requirements for Production Part Approval Processes (PPAP).
Collaborate with various teams to ensure product compliance with quality standards.
Manage supplier quality events and ensure adherence to established Key Performance Indicators (KPIs).
Lead root cause investigations and problem-solving initiatives with suppliers.
Resolve supplier-related quality complaints through cross-functional collaboration.
Benefits
Opportunity to work in a dynamic and innovative industry.
Access to a collaborative work environment with cross-functional teams.
Professional development and continuous improvement opportunities.
Engagement with global regulatory standards and compliance.
Opportunities to lead root cause analysis and supplier quality initiatives.
Full Job Description
Job Summary:
Provide support to the Supplier Quality organization dedicated to the oversight of components, materials, and services.
Serve as a technical resource across the organization to ensure suppliers meet all quality, regulatory, and business requirements.
Roles & Responsibilities:
Conduct technical reviews of suppliers to assess their capability to manufacture materials and components.
Oversee, assess, and monitor supplier manufacturing processes, quality control practices, corrective actions, continuous improvement activities, and First Article Inspections (FAI).
Define and approve PPAP (Production Part Approval Process) requirements for new and revised purchased parts.
Collaborate with suppliers, Research & Development, and Design Assurance teams to ensure products meet fit, form, function, reliability, and quality requirements.
Issue, manage, and follow up on supplier quality events including SCARs, SACAs, and NCEs while monitoring workflow compliance with established KPIs.
Partner with suppliers to perform root cause investigations, problem solving, metrology assessments, and statistical analysis to prevent recurring failures.
Work with Post Market Surveillance, Quality Engineering, Manufacturing Engineering, R&D, and other cross-functional teams to resolve supplier-related complaints and quality issues.
Manage supplier-related nonconformities, containment actions, material disposition activities, and supplier sample returns as required.
Maintain complete and accurate supplier quality records.
Generate supplier performance metrics and reports to support stakeholder decision-making.
Qualify, coordinate, and execute activities associated with onboarding and implementation of new suppliers.
Utilize problem-solving tools such as SPC, TQM, and statistical sampling methodologies to optimize processes.
Ensure compliance with Medical Device Regulations, cGMP, CFR 820, ISO 13485, ISO 14971, ISO 9001, and applicable global regulatory requirements.
Support risk management activities, validation efforts (IQ, OQ, PQ), CAPA investigations, project management initiatives, and measurement system analysis (GR&R, ).
Education & Experience:
Bachelor's degree in an Engineering field from an accredited university.
Minimum 8 years of professional experience.
Medical Device industry experience required.
ISO 13485 Lead Auditor certification required.
Strong knowledge of Medical Device Regulations, cGMP, CFR 820, ISO 13485, ISO 14971, and ISO 9001.
Experience with risk management, CAPA, IQ/OQ/PQ validations, measurement system analysis (GR&R, ), SPC, statistical sampling, and PPAP.
Knowledge of project management techniques and global regulatory requirements (FDA, Canada, Brazil, Japan, etc.).
