Johnson & Johnson Careers
Quality Manager, Operations
Requisition ID: 8054180726
MegaDyne Medical Products, Inc., a member of the Johnson & Johnson Family of Companies, is hiring a Quality Manager, Operations 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.
You the Quality Manager, Operations will, plans, coordinates and directs quality improvement programs to ensure continuity of quality supply. Know and follow EES policies and procedures; ensure that direct reports know and follow EES policies and procedures related to work activities performed in area of responsibility. Complete training in area of responsibility and ensure that direct reports are trained in area of responsibility within allowed time-period. Training is required for changes in existing policies and procedures, for new assignments and for implementation of new policies and procedures. Complete required periodic re-training and ensure that required periodic re-training takes place for direct reports in areas such as safety and environmental.
- Set standards for safe behavior. Recognize and reward safe behavior in others. Ensure that direct reports employ safe practices. Enforce safety policies & procedures. Evaluate staff member’s safety performance and ensure that safety is a part of each direct report’s GPMS. Provide resources (time and money) necessary to maintain safety process. Ensure safety structure is in place in form of working committees and department coordinators
- Plans, coordinates, and directs quality assurance programs to ensure continuous production of products consistent with established standards by performing designated duties personally or through subordinates.
- Responsible for ensuring that the quality management system is effectively defined, documented, implemented, and maintained and reporting its performance to top management.
- May also have responsibility for electronic systems by performing designated duties personally or through subordinates
- Establishes and maintains objectives, programs, procedures and controls to support the quality policy and mission.
- Ensure that product quality and functionality requirements are met.
- Supports / approves validations and related strategies.
- Responsible for compliance with all corporate regulatory, human resource programs, policies, procedures, safety/environmental systems and regulations governed by local and international agencies and authorities.
- Oversee capital related projects and monitor controllable spending for the department.
- Lead or participate in regulatory agency interaction: FDA (Food & Drug Administration), TUV, J&J CQA during audits or other information inquiries.
- Support projects and new product introductions by establishing key checkpoints for new products and processes.
- Provide for associate development by setting standards, managing expectations & coordinating training programs.
- Evaluate and recommend staffing requirements to ensure maximum utilization of personnel to fulfill department objectives.
- Assist with problem solving, decision-making & conflict resolution through coaching & counseling.
- Partner with cross-functional leaders to meet goals and objectives including support to Plant Wide Initiatives.
- Assure that EES and it’s internal manufacturing facilities, component suppliers & external manufacturers have strong, capable quality systems & are in compliance with government & corporate regulations.
- Lead efforts to increase the proficiency (skills and knowledge) of the organization through attainment of PE, and professional certifications.
- Assist w/Managing the Management Review process
- Lead Plant/Organizational initiatives driving business performance.
- Ensures compliance with Environmental Management System (EMS) responsibilities.
- A Bachelor’s degree and a minimum of 8 years of related work experience is required.
- Quality management and in leadership experience is preferred.
- Prior Supervisory experience is preferred.
- An advanced degree is preferred.
- Experience in a medical device, pharmaceutical or FDA regulated industry is preferred.
- CQE (Quality Engineer Certification), CQA (Quality Auditor Certification), CQM (Quality Manager Certification), Certified ISO (International Organization for Standardization) auditor is preferred.
- GMP/ISO knowledge is required.
- Knowledge or completion of Process Excellence Six Sigma, Lean, and/or Design Excellence courses or a comparable process for problem solving/ decision making is preferred.
- Green or Black Belt Certification is preferred.
- Strong organizational skills, time management skills and ability to self-manage in a complex/ time sensitive environment is required.
- Experience thriving in a collaborative work environment is required.
- This position will be located in Draper, Utah and may require up to 20% domestic and/or international travel.
Johnson & Johnson Family of Companies are equal opportunity employers, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.
MegaDyne Medical Products, Inc. (6250)