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 Highridge Medical to implement Highridge Medical's Quality goals.
Principal Duties and Responsibilities:
Formulates procedures, specifications, and standards for Highridge Medical products and processes.
Develops and implements corrective/preventative action plans.
Collects and analyzes data for gauge and product evaluation.
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 to Highridge Medical.
This is not an exhaustive list of duties or functions and may not necessarily comprise all of the "essential functions" for purposes of the ADA.
Expected Areas of Competence (i.e., knowledge, skills, and abilities)
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.
Education/Experience Requirements
B.S. in engineering or an alternative Bachelor's degree program with certification as a quality engineer (e.g. CQE).
3-5 years of work experience.
Certified Quality Engineer (CQE) and medical device, particularly Orthopedic industry, experience preferred
Combination of education and experience may be considered (in evaluating experience relative to requirements).