Overview
Tools & Automation Engineer Jobs in Los Angeles, CA at Apple
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.
Equal Employment Opportunity
It is our policy to provide equal employment opportunities without regard to race, color, religion, gender, sexual orientation, gender identity/expression, national origin, disability or protected veteran status. We believe that these opportunities should be available on the basis of individual merit, and we encourage applicants and employees to strive for advancement on this basis.
EOE AA M/F/Vet/Disability
Job Type: Full-time
Pay: $80,000.00 – $100,000.00 per year
Benefits:
401(k)
401(k) matching
Dental insurance
Health insurance
Life insurance
Paid time off
Vision insurance
Schedule:
Day shift
Monday to Friday
Overtime
Weekends as needed
Work Location: In person
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Title: Tools & Automation Engineer
Company: Apple
Location: Los Angeles, CA
