Vacancy expired!
- Initiate and lead the development and review of validation policies, master plans and schedules, and protocols and quality engineering issues.
- Preparation of audit schedule and audit assignments, training auditors, conducting audits, and monitoring the performance of the audit process, as appropriate.
- Initiate and lead investigations involving manufacturing nonconformances, product or component failures, customer complaints, or product returns by leading or participating in the investigation process, technical troubleshooting, FMEA, hazard, or other risk analysis, determining root cause and recommending CAPA/SCRs.
- Compile Quality metrics, analyze trends and report to Quality Management.
- Initiate and lead design process characterization studies.
- Participate in Design Control on New Product development teams including advising the team on design control requirements and then develop, review and approve design control deliverables related to quality engineering and validations.
- Bachelor's degree in Engineering or sciences or equivalent combination of education and experience. Advanced degree preferred.
- 3+ years of experience in validation in the medical device or pharmaceutical industries including the use of FDA Quality System Regulation and ISO 13485.
- Understanding of manufacturing processes such as injection molding, assembly, packaging, and sterilization required.
- Knowledgeable about regulatory/compliance/validation issues, be self-motivated, intelligent and reliable.
- Excellent project management, organization, writing, communication and presentation skills required.
- Must have strong written and oral communication skills in English.
Vacancy expired!