Date Posted: October 21, 2015
Employment Type: Contract To Hire
Job Id: 6358
Provide quality engineering technical support to the entire business related to corrective actions, process control, statistical analysis, customer complaints, component validation, product measurement and testing, product launch, product certification, and audits.
Duties and Responsibilities
- Investigates customer returns and complaints and provide corrective action / customer problem resolution at customer facilities
- Implementation of corrective action measures to prevent re-occurrence
- Performs product validation preparation and presentation of medical components and/or products.
- Experience developing and conducting IQ,OQ,PQ
- Provides product metrology and measurement
- Provides frequent instruction, guidance and direction for manufacturing, engineering, materials, customers and suppliers in performance measurement
- Calibrates, validates and maintains gauge and equipment calibration
- Performs preventive action and continuous improvement
- Performs internal system and process audits
- Performs SPC and capability analysis
- Creates C of C / C of A documents for product shipments
- Supports manufacturing and engineering problem solving efforts on in-process and vendor related quality problems
- Supports product development and production transfer to ensure process capability exists and product requirements are understood
- Participates in conducting both internal and vendor audits
- Improves and monitors inspection processes
- Installs statistical sampling processes
- Issues corrective action reports
- Associates degree or equivalent in quality, operations management or engineering related fields plus a minimum of 5 years quality experience in manufacturing environment.
- Experience in ISO quality system procedure requirements.
- Quality Engineer (CQE) certification and/or training a plus.