Modis is seeking a Quality Engineer in Warsaw, IN for 6-month contract for a leading biomedical company.
Responsible for assuring products conform to established requirements and standards through appropriate audit, inspection, and test activities. Interacts with many different functional departments, suppliers, and experts outside of company to implement Quality goals. Medical Device and/or Pharmaceutical experience highly preferred.
· Formulates procedures, specifications, and standards for products and processes.
· Develops and implements corrective/preventative action plans (CAPA).
· Reviews and/or assists in the execution of equipment and process Validations (IQ/OQ/PQ)
· Collects and analyzes data for trending purposes.
· Identifies critical personnel, gauges, procedures, and materials needed for the completion of new products.
· Ensures that suppliers have necessary information and facilities to deliver quality products.
· Knowledge and Understanding of Medical Device and/or Pharmaceutical regulations
· Ability to work within a team environment and build relationships outside of the department as well as outside the company (suppliers, regulatory agencies, etc.).
· Ability to deliver, meet deadlines and have results orientation.
· Able to communicate both orally and in written form to multiple levels of the company.
· Demonstrates characteristics of high potential for future development opportunities.
· Microsoft Office Suite
· Basic knowledge of blueprint reading and geometric dimensioning and tolerancing, basic understanding of QSR/ISO regulations, design assurance, FMEA, and product testing methods, and are able to use optical comparators and CMMs.
· B.S. in engineering or an alternative Bachelor’s degree program plus 3 years experience in a Quality Engineering role, or an equivalent combination of education and experience.
· Certified Quality Engineer (CQE) preferred.
· Medical Device and/or Pharmaceutical experience preferred.