Senior Quality Engineer
Position Description
Senior Quality Engineer - Med Device
Senior Quality Engineer - Medical Device
Leader in the Medical Device industry is currently in immediate need of a Senior Quality Engineer to join their team. (Possibly two openings / immediate needs.)
Permanent/Direct Placement with client - Up to low $80's/year plus relocation assistance.
You will be responsible for the development, implementation and administration of quality specific, test methodologies, and plans for product and process within manufacturing environment.
* Medical Device / FDA regulated environment experience required - preferably high volume, automated manufacturing related.
* May supervise up to 10 direct reports.
* Must have expert level of experience and understanding of FDA regulations and ISO 13485, MDD and CMDR.
* Will participate in internal audits, supplier audits, and essessments by external parties.
* Will perform product risk assessment, failure mode effects analysis (FMEA) and statistical analysis of various process parameters and/or test results of both finished products and subassembly products.
* Must be willing to become a Certified Quality Engineer (CQE) within the first year of employment.Company sponsored if certification if not already obtained.)
MINIMUM REQUIREMENTS:
Education:
* Bachelor's degree from an accredited college or university required in a technical field, Engineering preferred.
Experience:
* Years experiend working within an FDA regulated industry in a Quality Assurance function.
Preferred Skills/Qualifications:
* Supervisory experience.
* Certified Quality Engineer (CQE) or Certified Quality Auditor (CQA) credential desired. Six Sigma or Lean training desired.
Position is currently open available, priority to fill need as there is possibly an additional Quality Engineering opening.
