MedTech Quality Engineer

3 weeks ago

Vandalia, United States Johnson Electric Group Full time

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Quality Engineer/Medical-Onsite

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locations

United States, Vandalia

time type

Full time

posted on

Posted Yesterday

job requisition id

R00022158

Come Innovate Motion with us The Quality Engineer for Vandalia, OH., will support all aspects of the Quality Assurance (QA) program within the Quality Management System (QMS). The QE reports to the Q&R Manager. This position will lead all customer and third-party quality audits. Participate in Design Project Teams as a QE/QA Representative to ensure that input requirements (internal, external, and customer) are clearly defined, risk assessment is performed, output meets input requirements, and objective evidence clearly supports conclusions. Perform quality related design control activities as assigned by Design Project Team. Partner with production during Design Transfer phase to ensure that products and processes meet all quality requirements. Your responsibilities will be: ·

Lead QE function within new product teams to ensure customer and regulatory requirements are met along the product development cycle. ·

Develop and implement quality system per ISO13485 and customer requirements. Create production, calibration, inspection, and maintenance procedures as required. ·

Use Failure Modes Effects Analysis (FMEA), Fault Tree Analysis (FTA), Fish Bone Diagram, Risk Analysis, or other appropriate quality tools to define and manage risk or identify root cause of failure. ·

Lead the resolution of quality issues related to non-conformance reports, customer complaints, regulatory actions, etc. Support CAPA investigations and related corrective and preventive actions. ·

Assist in development, review and approval of process and equipment

validation/qualifications

(IQ, OQ, PQ). Develop, review and improve inspection plans, standard work sheet and product drawings. ·

Lead continuous improvement activities. Support Kaizen activities and re-work/scrap reduction. Our Requirement: ·

Bachelor ‘s Degree in Engineering or Physics ·

Minimum of 4 years’ experience as a QE (or equivalent) in the medical device or automotive industry Preferred Qualifications: ·

Current ASQ CQE or CQE in progress ·

E

xperience in the practical application of statistical process control, quality techniques and FDA Quality System Regulation and ISO 13485 or equivalent · What We offer: JE offers talented employee’s exceptional opportunities to learn and grow professionally with rewarding careers. We offer a competitive benefits package including medical, dental, prescription plan, vision, disability coverage, life insurance coverage, 401K match, and holiday/vacation benefits. Come join our global, inclusive & diverse team

Our purpose is to improve the quality of life of everyone we touch through our innovative motion systems. We are a truly global team bound together by our shared values. Our culture is built on the diversity, knowledge, skills, creativity, and talents that each employee brings to the company. Our people are our company’s most valuable asset. We are committed to providing an inclusive, diverse and equitable workplace where employees of different backgrounds feel valued and respected, regardless of their age, gender, race, ethnicity or religious background. We are committed to inspiring our employees to grow, act with ownership and find fulfilment and meaning in the work they do.

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