Previous Job
Quality Engineer
Ref No.: 17-00083
Location: Warsaw, Indiana
Position Type:Right to Hire
Start Date: 03/20/2017
This position is expected to support key post market quality efforts within orthopedic business units, including, but not limited to –
o investigation of released product nonconformance's, complaints, post market trend trigger events, and health hazard analysis in collaboration with other functions (product development, manufacturing, personnel with medical expertise, etc.), as well as other activities in the post-market group as needed.
o Develops, modifies, applies and maintains quality standards and protocol for processing materials into partially finished or finished materials product.
o Collaborates with engineering and manufacturing functions to ensure quality standards are in place.
o Devises and implements methods and procedures for inspecting, testing and evaluating the precision and accuracy of products and production equipment.
o Experience with reportability

Principal Duties and Responsibilities
o Formulates procedures, specifications, and standards for Client products and processes.
o Develops and implements corrective/preventive action plans.
o Collects and analyzes data for product evaluation.
o Collects, analyzes, and reports on post market data.
o Performs product issue investigations from initiation, risk evaluation, result reporting, and closure.

Expected Areas of Competence
o Ability to work within a team environment and build relationships outside of the department as well as outside the company (suppliers, regulatory agencies, etc.).
o Ability to deliver, meet deadlines and have results orientation.
o Strong communication skills both orally and in written form to multiple levels of the company.
o Demonstrates characteristics of high potential for future development opportunities.
o Microsoft Office Suite
o Basic knowledge of blueprint reading and geometric dimensioning and tolerancing, familiarity with QSR/ISO regulations, design assurance, FMEA, and product testing methods.
o Education/Experience Requirements
o B.S. in engineering or an alternative Bachelor's degree program with certification as a quality engineer (e.g. CQE).
o 0-3 years of work experience.
o Certified Quality Engineer (CQE) and Medical device, particularly Orthopedic industry, experience preferred.
o Combination of education and experience may be considered (in evaluating experience relative to requirements).
o Bachelors degree in sciences, health care certificates, mechanical or biologic chemistry, or biomedical engineering, or related field and a minimum of 2 years of related experience.