Associate Quality Engineer
About The Position
About MedTech Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments. Your unique talents will help patients on their journey to wellness. Learn more at https://www.jnj.com/medtech At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com/. This is a field-based role available in all cities within Cincinnati. While specific cities are listed in the Locations section for reference, please note that they are examples only and do not limit your application. We invite candidates from any location to apply. We are searching for the best talent for Associate Quality Engineer. Purpose: This position will support Lifecycle Engineering within the Quality organization, based in Cincinnati, OH The role of a quality engineer at Ethicon is to apply the principles of engineering, mathematics, statistics, organizational excellence, and risk management to help the company achieve two major objectives in support of the J&J Credo: Meet and exceed the expectations of our customers Achieve and maintain compliance with regulatory expectations Provides overall quality assurance leadership in the management of select contract manufacturing sites engaged in the production of Johnson and Johnson products. Conducts audits to good manufacturing practices, international organization for standardization and any other applicable standards. Provides quality engineering and quality design services to manufacturing and production engineering groups. Develops quality concepts, designs and details for machines, tools, fixtures, and products.
Requirements
- Graduates with STEM (Science, Engineering, Technology, and Math) degrees.
- Non-STEM graduates with follow-on technical training or experience will also be considered. Appropriate relevant advanced degrees are preferred.
- Generally requires no minimum work experience. Experience in a regulated industry or veterans with leadership experience will be given preference.
- Experience in regulated medical, biopharmaceutical, or pharmaceutical industry may be preferred or required depending on the job level. This would be experience in: 21 CFR 820, 21 CFR 210 / 211 / 606, Medical Device Directive (MDD), EU Regulation 2017 / 745 (MDR, ICH Q8, ICH Q10, and / or ISO 13485 as applicable to the business need. Efforts would support regulatory submittals of PMA, BLA, 510(k) or maintenance of such regulated product.
Nice To Haves
- Healthcare Quality
- Quality Compliance
- Quality Engineering
- Quality Improvement
Responsibilities
- Supports established contract manufacturing sites via conducting audits, driving compliance and quality improvement initiatives.
- Assists in the resolution of process and product nonconformance events.
- Collects and escalates product or process complaints.
- Prepares audits of all quality system categories to assess compliance to process excellence standards.
- Implements basic measurement systems to monitor effectiveness of quality and reliability systems to identify, bracket, correct and prevent defects, demonstrating continuous improvement to management.
- Assists in technical issues for manufacturing processes that are to be transferred to satellite facilities.
- Uses analytical/statistical techniques and may use finite element analysis to assist product testing.
- Assists with various hands-on testing for design verification and test method developments.
- Supports engineering tasks, and conducts basic scientific research on new products, technology concepts, and product development. May draw/assist with quality aspects of preliminary sketches and preparing/reviewing layout and detail drawings.
- Drafts engineering documentation related to assigned projects, such as technical reports, work instructions and method and process validation.
- Performs basic algebraic and geometric formulas and standard engineering data to support design configuration.
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
