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Quality Engineer

System One
North Brunswick, NJ
  • Posted: August 08, 2022
  • Full-Time

Title: Quality Engineer

Location: North Brunswick, NJ

Schedule: Monday - Friday (8am-5pm)

Type: Direct Hire

Start date: ASAP

Responsibilities:

+ Read and interpret standards in the areas sterilization, bioburden, endotoxins, and relevant product testing for development and modification of procedures and protocols

+ Oversee supplier management program including supplier audits, methods to ensure compliance with regulatory and company requirements, supplier qualification, and supplier performance monitoring

+ Own and/or support root cause determinations and execution of corrective actions per Non-Conforming Material Reports (NCMR's) and Corrective Actions & Preventive Actions (CAPA's)

+ Facilitate environmental monitoring and ensure compliance to applicable standards and company procedures. Understands and executes risk management practices in relation to environmental monitoring and bioburden and relevant excursion

+ Prepare and execute validations, technical studies, test method validations and other studies / reports as required. This includes preparation of protocols, establishment of test methodology and acceptance criteria, training personnel, execution, data analysis, investigation, and writing final reports. Analyze and report quality system data, as needed, to the Quality and Manufacturing teams

+ Applies statistical process control (SPC) methods for analyzing data to evaluate the current process and process changes

+ Utilize statistical techniques and six sigma tools to analyze processes to drive continuous improvement and/or identify performance changes.

Requirements:

+ Bachelor's Degree in Microbiology, Biology, Biomedical Engineer, or equivalent field from an accredited four year college or university

+ 2-6 years of equivalent experience in a related field, preferably in Medical Device

+ Functional understanding of medical device standards ISO 13485, ISO 11138-7, and ISO 14971

+ Experience in using MS Word, Excel, Power Point and Outlook

+ Strong oral and written communication skills

Joule, a System One division is a leader in specialized workforce solutions and integrated services. With more than 6,000 employees and roughly 50 offices throughout the U.S. we provide scientific, clinical, engineering, energy, IT, legal and administrative staffing services. For more than 40 years, we have delivered workforce solutions and integrated services to clients nationally.

System One, and its subsidiaries including Joule, 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.

System One

Address

North Brunswick, NJ
08902 USA

Industry

Manufacturing

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