Johnson & Johnson's Cardiovascular & Specialty Solutions (CSS) Group within Medical Devices is recruiting for a Quality Engineering Manager for Sterilmed located in Plymouth, MN. Less than 10% domestic travel is required.
The CSS Group serves a diverse base of customers in Ear, Nose and Throat (ENT), Infection Prevention, Electrophysiology (EP), Surgical and Non-Surgical Aesthetics, Neurovascular, and Reprocessing. The CSS Group is committed to delivering innovative products, solutions and programs to address unmet customer and patient needs around the world. Our customers and the patients they treat are our first priority and these values are reflected in Our Credo, which guides our daily decisions and actions. Our relentless commitment to Quality and the principles that define us in Our Credo have helped us achieve significant milestones and continues to help us deliver significant growth year after year.
The Quality Engineering Manager defines, leads and implements state-of-the-art quality engineering focus and improvements in design and development of products, and in transfer and steady state phases of manufacturing operations.
Other responsibilities include:
Providing review and approval for the release of new products ensuring quality requirements are met, including design verification and validation, process validation, stability testing, risk management, design transfer and design review.
Lead alignment discussions with NPD (New Product Development) Leadership Teams to gain organizational consensus on quality strategies to enable the best clinical outcomes for our customers and the robust commercialization of new products.
Manage Quality Engineers working on the NPD teams to execute quality engineering objectives (eg. Quality plans, validation strategies, testing strategy, etc.) in support of product development projects.
Lead design and implementation of world-class quality systems to support NPD with focus on business results including detection of defects at earliest phase of product design, customer satisfaction, reduced cycle time and cost of goods sold.
Provide Quality Systems monitoring for NPD teams, including regulatory, product stewardship and external standards trends. Set appropriate strategies and recommendations to assure compliance and assist in resourcing the execution of the strategies.
Experience with joint product development and/or working with external design house vendors during medical device new product development preferred.
Provide leadership in design and implementation of world-class quality systems to support the entire product life cycle with focus on business results including reduced cycle time, and lower COGS (Cost of Goods Sold), prevention, detection of defects at earliest phase of product design, continuous improvement and customer satisfaction.
Provide leadership, technical expertise and improvements in design, development and deployment of Quality and Reliability Engineering (tools and systems), ISO, FDA (Food and Drug Administration) and MDD (Medical Device Directive) based quality systems, SOQ and developing business metrics and analytical problem solving through sound statistical application.
Provide leadership and support to J&J process excellence initiatives including Six-sigma, design excellence and lean thinking.
Process Excellence (DMAIIC, DMADVV, and Lean).
Influencing bringing cross-functional and cross level people to consensus.
Risk Management (ISO 14971)
A Bachelor's degree in a Science, Technical or Engineering related field, is required.
Professional experience of 8 years in a related industry is required.
A minimum of 8 years of experience in Quality Engineering is required.
Experience understanding corrective and preventive action systems (CAPA), statistical analysis techniques, GMP, QSR, ISO 13485 requirements and auditing of suppliers is required.
Basic project management tools are required.
Understands specification drawings and departmental procedures. Understands Six Sigma tools, preferably Green Belt certified or higher, is required.
Experience working under minimum supervision and takes self-directed action is required.
Ability to develop and implement quality standards, understands business principles is required.
Ability to lead and influence others above direct authority is preferred.
ASQ certified in Quality Engineering is preferred.
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.
Sterilmed, Inc. (6215)
Johnson & Johnson