Quality Engineer I
We’re looking for a Quality Engineer I to support product and process quality within a regulated manufacturing environment. This is an entry-level engineering opportunity focused on ensuring products meet established quality requirements through inspection, testing, data analysis, and collaboration with internal teams and suppliers.
What You’ll Be Doing
- Develop procedures, specifications, and standards for products and manufacturing processes.
- Develop and implement Corrective and Preventive Action (CAPA) plans.
- Collect and analyze data for gauge and product evaluations .
- Support quality activities associated with new product development and introduction.
- Identify the personnel, gauges, procedures, and materials required to support new products.
- Partner with suppliers to ensure they have the information and capabilities needed to deliver quality products.
- Collaborate with cross-functional teams, suppliers, and regulatory stakeholders to support quality objectives.
- Support activities involving FMEA, design assurance, product testing, inspection, and quality compliance .
What We’re Looking For
- Bachelor’s degree in Engineering , or an alternative bachelor’s degree with Quality Engineer certification.
- Basic understanding of QSR and ISO regulations .
- Knowledge of FMEA, design assurance, and product testing methods .
- Basic knowledge of blueprint reading and GD&T .
- Experience or familiarity with CMMs and optical comparators .
- Strong communication, teamwork, organization, and problem-solving skills.
- Ability to work effectively with internal teams as well as external suppliers.
- Certified Quality Engineer (CQE) preferred.
- Medical device experience, particularly within the orthopedic industry, preferred .
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