- Directs quality assurance activities for product introductions and validations.
- Provides quality sustaining support for released production parts and activities.
- Establish and update the Quality System based on changes to pertinent regulations, audit observations and changes to existing products and processes.
- Manage and perform activities associated with CAPA, Complaints, Non-Conforming Materials, Risk Management, Sterilization Validation, Packaging, Biocompatibility Statistical Analysis, Inspection and Calibration.
- Assemble reports, amendments, supplement, and letters to file to support Quality System compliance.
- Develop and establish SOP' s according to regulatory requirements.
- Oversees qualification and management of the overall Supplier base.
- Lead others in the quality department through implementation and maintenance of the company quality system, reporting on the performance of the quality system for review and as a basis for improvement of the quality system.
- Other duties as assigned.
- Bachelors and/or advanced degree in a science or technical area or equivalent
- 4-7 years related experience and/or training; or equivalent combination of education and experience.
- Strong fundamental understanding of ISO 13485 requirements and/or ISO 9001
- Profession knowledge of GDT, measurement analysis, and measurement systems.
- Skilled at summarizing and analyzing data.
- Skilled in tool, equipment, and product validation.
- Skilled in risk assessment and analysis, i.e. flowcharts, pfmea, control plans, CAPA processing.
- Medical device experience preferred
- Six Sigma Black Belt certification a plus
- A CQE is preferred but not required.
Meet Some of PEAK Technical Staffing's Employees
Beau P.Lead Staffing Manager
Beau makes sure that recruitment job orders are always properly and perfectly filled by finding first-class candidates to fit open positions for clients.
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