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.
We are currently recruiting for a Quality Control Engineer who will be responsible for device quality and ongoing development and execution of our quality management system.
Job Duties & Responsibilities
Duties & Responsibilities:
* partner with Quality Manager to oversee internal and external auditing requirements
* quality system improvement
* prepares management review
* update and generate procedures
* document control, record maintenance and retention
* acceptance activities
* equipment calibrations
* use of valid statistical techniques
* customer communication
* other duties as assigned.
Job Requirements & Qualifications
Education and 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 minim 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.
Job Type: Full-time
Pay: $1.00 per year
Benefits:
- Dental insurance
- Health insurance
- Paid time off
- Vision insurance
Schedule:
- Day shift
- Monday to Friday
- Overtime
- Weekends as needed
Work Location: In person