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QA/QC Manager
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Who We Are
Occam Design (A Division of CreoSalus, Inc.) is an innovative leader in the development and manufacturing of the highest quality Class I & Class II medical devices.
Job Description
The Quality Control/Quality Assurance Manager will be responsible for maintenance and continuous improvement of quality management system for Medical Device Development and manufacturing.
Duties & Responsibilities
- Oversee internal and external auditing requirements
- Quality system improvement
- Schedules and prepares management review
- Primary contact for notified body and client audits
- Update and generate procedures
- Document control
- Acceptance activities
- Record maintenance and retention
- Equipment calibrations
- Use of valid statistical techniques
- Customer communication
- Other duties as assigned.
Education & Experience
- Four-year technical degree or equivalent combination of education, training, and experience
- 5-year minimum Medical Device or pharmaceutical experience.
- 3-year minimum supporting or directing ISO 13485 compliant quality management system
- 3-year minimum as QC or QA supervisor or manager
- 2-year minimum experience managing direct reports
- Knowledge of regulatory requirements and processes, labeling requirements, technical files and CE marking requirements, supplier management, knowledge of ISO and ASTM test methods and standards
- Other skills - Supervisory and related people skills, auditing, inspection, statistical techniques and data analysis, technical writing, risk analysis and FMEA, corrective and preventive action including problem solving and root cause analysis, quality system plans, project planning and quoting, test method development and validation including GR&R, sampling plans, intermediate to advanced MS office skills Fluent knowledge of CFRs and 14971, 60601, 62304, 62366, UDI standards and guidelines.
Occam Design is an equal opportunity employer and gives consideration for employment to qualified applicants without regard to race, color, religion, gender, sexual orientation, gender identity/expression, national origin, disability or protected veteran status.