Job Description
Job Description
Description : Purpose
This position is responsible for providing Quality Engineering support in the design, development,
manufacture and post-market medical device activities.
Responsibilities
- Assist in performing validation activities for processes, facilities, manufacturing, and test
equipment in compliance with domestic and international regulations
Support quality assurance activities, including, but not limited to : NCMRs and CAPAsInvestigate product quality problems and determine root cause, gather and analyze data, andimplement corrective actions to reduce or eliminate cause
Assist in the resolution of quality issues related to non-conformance reports, CustomerComplaints and CAPAs
Provide Quality support to production and engineeringFailure Analysis - Provide quality engineering support to analyze returned productUnderstands root cause investigation process and able to initiate routine problem-solvinginvestigations
Assist in the timely investigation, resolution, and prevention of supplier quality issues whichcould disrupt business operations
Drive corrective actions for supplier processes by driving suppliers to true root causeanalysis and corrective and preventive actions
Participate in the initiation, issuance, review, and approval of Supplier Corrective ActionReports (SCARs)
Collaborate with Operations on process improvement projectsInvestigate customer complaints and document investigation findingsPerform inspection of incoming components, materials and productsRequirements : Qualifications
4-year degree in an Engineering or Science discipline2 years minimum experience in a medical device environmentWorking knowledge of specifications, work instructions, standard operating procedures,regulations, and standards
Ability to use word processing, spreadsheet programs, and email such as MS Office and ExcelSalary & Benefits
The estimated hiring salary range for this position is $65,000 - 70,000 .
The actual salary will be based on a variety of job-related factors, including geography, skills, education and experience. The range is a good faith estimate and may be modified in the future. This role is also eligible for a range of benefits including medical, dental and 401K retirement plan
Salary : $65,000 - $70,000
