Progressive Medical Device Manufacturer is looking for a Quality Engineer

　　Position Overview:

　　· Work with Manufacturing to ensure quality and compliance of finished products.

　　· Responsible for yields, scrap reductions, and process improvements working with manufacturing and production.

　　· Lead CAPA process to get to true root cause and ensure timely completion.

　　· Investigate and document customer complaints.

　　· Assist with improvement projects to reduce defects and increase reliability.

　　· Assist with new product development and introduction.

　　· Assist with supplier management and SCAR (supplier corrective action request) process.

　　· Assist with training and documentation.

　　· Monitor and improve health of QMS.

　　· Assist with internal, supplier, and regulatory audits when required.

　　Education, Experience, Skills, and Abilities:

　　· Bachelors degree in Engineering, Life Science or equivalent

　　· At least 2 years of experience in relevant position

　　· Medical device industry and FDA experience preferred

　　· Manufacturing experience and knowledge a must

　　· Knowledge of quality systems & working with policies (ISO 9001, ISO 13485, 21CFR820, MDR)

　　· Product and process audit skills

　　· Knowledge and experience in standards and regulatory requirements

　　· Supplier evaluation process skills

　　· ERP systems and MS Office knowledge

　　· Good documentation, communication, and interpersonal relationship skills

　　· Solid problem-solving, organizational, analytical, and critical thinking skills

　　· Excellent attention to detail

　　· Social and effective communication skills

　　· Planning and organizing skills

　　· Self-Management skills

　　· Ability to build productive internal/external working relationships

　　Team environment, very stable company, full benefits including 401K, room for advancement

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　　System One, and its subsidiaries including Joulé, ALTA IT Services, CM Access, TPGS, and MOUNTAIN, LTD., are leaders in delivering workforce solutions and integrated services across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible full-time employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.

　　System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.