Job description
Quality Engineer
Santa Rosa - CA
Medical Device
Start Date: ASAP
Salary: $75,000 - $110,000
In this role of a Quality Engineer you will perform metrology utilizing various metrology equipment. You will also develop, implement, and evaluate quality processes, procedures, controls, metrics, and statistical techniques.
Essential Responsibilities
· The development, implementation and maintenance of quality standards for all programs.
· Develop validation protocols, with customer input, monitor execution, and develop completion reports for approval.
· Responsible for First Article Inspection, pFMEA and Risk Analysis, Capability Studies, and customer driven requirements for device programs, GR&R.
· Corrective Actions and Supplier Corrective Actions.
· Identification of critical variables and attributes;
· Develops Inspection Instructions/Techniques
· Statistical analysis if required
· SPC dimensional monitoring for production;
· Identification of resources needed to meet or assess required quality;
· Preparation for quality assurance of initial trial and subsequent production;
· Identifies needed holding/locating devices for Measurement Analysis and Designs.
· Identifies opportunities for improvement to process and product
· Utilizes the CAPA and NCR systems to facilitate improvements.
· Performs various analyses as assigned: Identifies, quantifies, and monitors product and process quality;
· Measures various other performance indicators, Prepares various reports as assigned.
· Quality Planning, Non-Conforming Materials, Continuous Improvement, Weekly Meetings, Corrective/Preventive Actions, Audit Activities, etc.
· Supports the ISO 13485 Business Management System through Internal Auditing.
· Continuous Improvement, Conducts investigation, root cause analysis and corrective actions;
· Coordinates implementation of product and process improvements;
· Monitors and expedites the closure of corrective/preventive actions resulting from customer complaints, safety issues, management review.
Essential Qualifications:
· Bachelor’s Degree in technical related field preferred.
· Minimum of 3 years’ experience within Quality Assurance preferred.
· Excellent interpersonal communication and writing skills
· ASQ, CQT/CQE
· CMM/MicroVu Programming Experience
· Solidworks Modeling Software Experience
· Gage R&R, CpK/PpK studies,
· IQ, OQ, PQ validation/qualifications, DoE analysis… etc.
· Injection molding background
· Medical Device manufacturer background
· Experience using Minitab Software for SPC, DOE, etc.
· Various metrology equipment.
· Microsoft Office suite
· Statistical process control
Desirable Qualifications:
· Experience within the medical device industry.
· Previous experience with lean manufacturing concepts.
Job Type: Full-time
Salary: $75,000.00 - $110,000.00 per year
Benefits:
- 401(k)
- Dental insurance
- Health insurance
- Paid time off
- Vision insurance
Schedule:
- 10 hour shift
Ability to commute/relocate:
- Santa Rosa, CA: Reliably commute or planning to relocate before starting work (Preferred)
Experience:
- ISO 13485: 3 years (Required)
- Validation: 2 years (Preferred)
- injection molding: 2 years (Preferred)
- Manufacturing: 3 years (Required)
Work Location: One location
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