Johnson & Johnson Careers
Quality Systems Manager
Requisition ID: 0740180828
Johnson & Johnson’s Cardiovascular & Specialty Solutions (CSS) Group within Medical Devices is recruiting for a Quality Systems 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 Systems Manager is to manage quality systems (e.g. Internal Audits, Supplier Quality, Management Review, Field Actions, CAPA, Nonconformance, Document Change Control/Records Management, Training). Lead the continuous improvement of quality systems to facilitate business and quality objectives. Ensure appropriate metrics are defined and measured to enable monitoring/continuous improvement and promote alignment between local and shared processes and ensures appropriate risk management strategies are integral to the process.
• Ensure maintenance and implementation of requirements for quality processes, including operational oversight and continuous improvement for proactive quality management. Oversee quality system processes such as CAPA, internal audits, distribution controls, etc.
• Maintain and improve quality system documentation, i.e. policies and procedures to ensure ongoing compliance with quality system standards and requirements as well as current company and industry practices
• Facilitate and implement changes and improvements to the quality system to ensure the effective and efficient operation of the quality system.
• Functional knowledge of ISO (International Organization for Standardization), other applicable International regulatory regulations and Good Manufacturing Practices (GMP) per Code of Federal Regulations, Part 820, Part 11
• Provide leadership & support to J&J process excellence initiatives including Six-sigma, design excellence & lean thinking
• Support external audits from regulatory bodies and act as consultant in determining efficient and effective methods for meeting regulations
• Develop training materials and conduct quality system training on key subsystems
• Collect and analyze data from quality processes and generate regular reports
• Manage team, conduct performance assessments, co-create development plans with direct reports and provide feedback as appropriate
• Establish and maintain successful cross-functional relations with R&D, Engineering, Manufacturing, Marketing, Quality, and Regulatory Affairs departments
• A BS or BA in business, applied sciences, quality or engineering is required.
• An advanced degree & certifications- CQE (Quality Engineer Certification), CQA (Quality Auditor Certification is preferred.
• A minimum of 4 years of supervisory experience is required.
• A minimum of 6 years of industry experience with a minimum of 4 years’ experience in an ISO 13485 or GMP manufacturing environment, preferably in medical devices is required.
• Strong working knowledge of Quality System regulations and industry trends including ISO CFR regulations is required.
• Managing people and projects which lead to positive, tangible business results is required.
• Auditing for compliance to ISO standards for QMS, FDA QSR and CMDR is preferred.
• Experience with computer system implementations is required. Specific experience with Minitab, ETQ or Track-wise is preferred.
• Ability to negotiate, influence and lead without directs line authority is required, as is the ability to lead an organization through continuous improvement and change
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)