Manpower Engineering is seeking candidates for the permanent opportunity of a Quality Engineer for our client who is an innovative developer and manufacturer of medical devices for more than 30 years.
What you will be doing:
- Initiate and lead the development and review of validation policies, master plans and schedules, and protocols and quality engineering issues.
- Support site production and engineering functions in process quality improvement activities.
- Assist the internal and supplier audit processes.
- Preparation of audit schedule and audit assignments, training auditors, conducting audits, and monitoring the performance of the audit process, as appropriate.
- Perform internal and supplier audits as required.
- Support the risk documentation process, ensuring that product FMEAs, Hazard assessments, etc. are regularly updated as required.
- 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.
- Interface with external auditors during audits at sites and participate in the preparation and completion of corrective action plans as needed.
- Apply statistical methodologies, risk analyses and other quality engineering tools to manufacturing and design related issues.
- Coordinate contractor qualification activities with appropriate departments.
- 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.
What you will need:
- Bachelor's degree in Engineering or sciences or equivalent combination of education and experience. Advanced degree preferred.
- 3+ years of experience in validation and quality engineering 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.
- Experience in writing technical documents, especially compliance, validation and quality assurance documents and protocols will be required.
- Ability to format, trend and present information using basic quality tools.
- Ability to compile, analyze, graph, and compare data using standard statistical techniques.
- Demonstrated expert knowledge of Windows including Word, Excel, Access, Project, and Power Point.