Johnson & Johnson Careers
Staff Quality Engineer
Requisition ID: 0961180830
The Ethicon Surgical Care business a member of Johnson & Johnson's Family of Companies, is currently recruiting for a Staff Quality Engineer located in Draper, Utah.
You, the Staff Quality Engineer will be responsible for support and leadership of Quality Engineering activities in New Product Development and Life Cycle Engineering for our Megadyne products within our Energy platform.
Responsibilities include but are not limited to:
- Provide leadership in design & implementation of world-class quality engineering to support entire product life cycle with focus on quality engineering activities such as reliability, risk management, analytics/statistical techniques, requirements management, verification & validation, and design control across the lifecycle of the product. Activities would drive prevention, detection of defects at earliest phase of product design, continuous improvement & customer satisfaction.
- Provide leadership, technical expertise to ensure conformance to ISO, FDA (Food & Drug Administration) & MDD (Medical Devices Directive) based quality systems. Support global product registration needs by acting as liaison for technical questions in the areas of product testing as it pertains to design control and compliance to external standard, such as the IEC 60601 series of standards.
- Provide review and approval for the release of new products ensuring quality requirements are met provide leadership & support to J&J process excellence initiatives including Six-sigma, design excellence & lean thinking.
- Direct development & consistent application of quality policies & procedures in product design & development, secondary development & transfer operations.
- Act as technical liaison, as needed, between product development, manufacturing, external manufacturers & suppliers.
- A minimum of a bachelor’s degree is required, a degree concentration in Engineering, Life Science, Physical Science or a related field is preferred; an advanced degree is an asset.
- A minimum of 6-8 years of experience of related work experience is required. Experience in the medical device industry is strongly preferred. Experience with medical electrical-mechanical systems an asset.
- Experience in statistical methods, and data analysis required. Knowledge of Good Manufacturing Practices (GMPs) and ISO policy and procedures is preferred. Knowledge of FDA requirements for design control of medical devices, particularly with verification and validation of software for medical electrical equipment, an asset.
- Experience driving risk management discussions, particularly as it relates to cascading identified product issues/hazards into potential user harms.
- Demonstrated Project management skills, such as supporting multiple projects simultaneously are required.
- Reliability test method development, planning, and execution an asset.
- Experience with medical electrical safety standards (such as the IEC 60601 series of standards) preferred.
- An ASQ certification (CQE, CQM, CRE or CQA) is an asset. Six Sigma (Green Belt, Black Belt, etc.) or Process Excellence certification is an asset.
- This position will be located in Draper, Utah and will have up to 20% travel both domestic and international.
Do you strive to join an outstanding team that is dynamic and ever-changing? Is career growth and opportunity appealing to you? Apply to this opportunity today.
Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
MegaDyne Medical Products, Inc. (6250)