Quality Engineer - Entry Level
Working with our medical device client, you will be responsible for gathering relevant, factual information and data in order to solve quality related problems. Execute projects according to defined timelines. Work effectively with all departments by developing a team atmosphere. 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 outside experts to implement Quality goals.
Principal Duties and Responsibilities
- Formulates procedures, specifications, and standards for products and processes.
- Executes quality engineering projects according to defined project deliverables and timelines.
- 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.
Expected Areas of Competence
- Ability to think independently and critically in order to identify quality gaps in existing procedures, manufacturing processes and product documentation.
- 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.
- Microsoft Office Suite, expert knowledge of blueprint reading and geometric dimensioning and tolerancing, understanding of QSR/ISO regulations, design assurance, FMEA, and product testing methods, and are able to use optical comparators and CMMs.
- Knowledge of statistics, process control, and process capability
- B.S. in engineering or an alternative Bachelor’s degree program with certification as a quality engineer (e.g. CQE).
- Certification as a quality engineer (e.g. CQE) or the Reliability Engineer Certification (CRE) granted through the American Society of Quality (ASQ) preferred
- Minimum 1-2 years experience in a Quality Engineering role, or an equivalent combination of education and experience.
- Combination of education and experience (internship/co-op) may be considered (in evaluating experience relative to requirements)