Johnson & Johnson Careers
Staff Quality Operations Engineer
Requisition ID: 5259180628
MegaDyne Medical Products, Inc., a member of the Johnson & Johnson Family of Companies, is hiring a Staff Quality Operations Engineer located in Draper, Utah.
With worldwide sales of over $27 billion, Johnson & Johnson Medical Devices is one of the world’s largest, most innovative surgical companies. The businesses represented in the J&J Medical Device sector are Acclarent, Advanced Sterilization Products, Biosense Webster, DePuySynthes, Ethicon, Mentor, and Sterilmed, MegaDyne, Coherex and Olive Medical.
Thriving with a diverse company culture, celebrating the uniqueness of our employees and committed to inclusion. We are proud to be an equal opportunity employer.
You, the Staff Quality Operations Engineer will be responsible for establishing and improving Quality Assurance practices and procedures. S/he will also be responsible for design and evaluation of Quality Systems sampling plans and inspection methods. S/he will be responsible for reviewing and recommending solutions to quality problems.
• Evaluate and/or design sampling plans and process control plans for lot acceptance and control processes.
• Study the effectiveness of inspection activities.
• Design means for measuring accuracy and documenting of inspection work.
• Evaluate and recommend inspection gauges and test equipment.
• Investigate causes of sporadic defects.
• Provide consultation services to site departments including but to limited to Manufacturing.
• Hire, supervise and train Quality technicians, as applicable.
• Implement process control systems.
• Technical support for component, product and process validations.
• Provide technical support for new product transfer.
• Coordinate training of manufacturing associates as applicable.
• Establish and maintain appropriate documentation as required for Quality Systems activities.
• Investigate identified quality problems.
• Develop systems for new processes as required.
• Coordinate investigations on items returned to the Draper facility for analysis.
• Support CAPA investigations and tasks, to determine root cause and corrective actions needed.
• Maintain trend information on field failures.
• Support manufacturing in analyzing manufacturing product lines to determine how or where, within the manufacturing or inspection process, the root cause of non-conformances or customer complaints exist.
• Execute Statistical Analysis that includes: ANOVA, DOE, Weibull, GR&R, Capability, FMEA, KTA and SPC as required.
• Perform, enhance and validations: for manufacturing processes, gauges, equipment, software and computerized systems as required.
• Prepare written protocols as necessary.
• This role can also execute, as designated, responsibilities related to site leader for NCR/CAPA/Complaints processes. This role includes but is not limited to being responsible to manage NCR and CAPA electronic system and process, serve as liaison for the complaints investigation process, escalations in addition to responsibilities for compiling the Management Review among others.
• Interface with manufacturing area and other support groups to ensure department objectives are met.
• A minimum of a bachelor’s degree is required, preferably in Engineering or Applied Sciences.
• A minimum of six (6) years of business related experience is required.
• Prior quality control experience in a medical device industry is preferred.
• Ability to understand application of regulatory requirements to the business is preferred.
• Ability to analyze and develop quality methods, responsible for writing clear and concise protocols, study reports, and procedures is required.
• Basic project management experience is required.
• Prior supervisory/management experience is preferred.
• Proficiency with PC based systems and Microsoft Toolsets is required.
• Good communication skills to effectively present information both orally and in writing to diverse groups is required.
• Strong organizational skills, time management skills and ability to self-manage in a complex/ time sensitive environment is required.
• Prior experience effectively working through periods of change, ambiguity and complexity is required.
• Experience thriving in a collaborate work environment is required.
• This position is located in Draper, UT and may require up to 10% travel.
MegaDyne Medical Products, Inc. (6250)