Quality Engineer – Medical Devices (CAPA & SPC)
Top Echelon Software
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Benefits offered by this job
Job summary
Top Echelon Software seeks a Quality Engineer for a medical manufacturing environment in Sault Ste. Marie, MI.
The role focuses on ensuring product quality, process capability, and regulatory compliance within a highly regulated manufacturing setting. The successful candidate will develop and maintain quality systems, lead continuous improvement projects, and collaborate with manufacturing, engineering, suppliers, and customers to uphold top quality standards.
Qualifications
- Bachelor's degree in engineering required.
- 3 years of quality engineering experience in manufacturing preferred.
- Experience with multiple types of precision measuring equipment.
Responsibilities
- Support manufacturing operations with quality activities.
- Develop inspection plans for new and existing products.
- Lead CAPA and MRB activities.
- Develop PFMEA and Control Plans.
- Support process validation and product validation activities.
- Perform process capability studies and SPC analyses.
- Develop and maintain SPC programs and measurement systems.
- Conduct Gage R&R and Measurement System Analysis.
- Improve inspection methods and quality procedures.
- Program and support inspection equipment.
- Conduct vendor audits and supplier quality activities.
- Support internal and external customer audits.
- Develop and update work instructions and quality documentation.
- Train employees on quality procedures and inspection standards.
- Collaborate with suppliers and customers to standardize inspection processes.
Skills
Education
Job description
Top Echelon Software seeks a Quality Engineer for a medical manufacturing environment in Sault Ste. Marie, MI.
The role focuses on ensuring product quality, process capability, and regulatory compliance within a highly regulated manufacturing setting. The successful candidate will develop and maintain quality systems, lead continuous improvement projects, and collaborate with manufacturing, engineering, suppliers, and customers to uphold top quality standards.
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