JOB DESCRIPTION:
We are seeking a Quality Engineer I to ensure products and processes meet established quality requirements through audits, inspections, testing, and data analysis. The role works closely with internal teams, suppliers, and external partners to support quality objectives.
Key Responsibilities
- Develop and implement quality procedures, specifications, and standards.
- Support corrective and preventive action (CAPA) activities.
- Collect and analyze data for gauge and product evaluation.
- Support new product quality activities, including identifying required personnel, gauges, materials, and procedures.
- Work with suppliers to ensure quality requirements and necessary information are met.
- Perform audits, inspections, testing, and quality investigations.
Required Qualifications
- Bachelor’s degree in Engineering or related field; CQE certification is a plus.
- Basic knowledge of blueprint reading and GD&T.
- Understanding of QSR/ISO regulations, Design Assurance, FMEA, and product testing.
- Experience or familiarity with optical comparators and CMMs.
- Proficiency with Microsoft Office Suite.
- Strong communication, teamwork, problem-solving, and organizational skills.
Preferred Qualifications
- Certified Quality Engineer (CQE).
- Medical device industry experience, particularly orthopedic products.
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