Johnson & Johnson Careers
Senior Manager, Quality Operations
Albuquerque, New Mexico
Requisition ID: 9255180809
Johnson & Johnson's Family of Companies is recruiting for an Senior Manager, Quality Operations to be located in Albuquerque, NM to support our Medical Devices business.
Johnson & Johnson Medical Device Companies produce a broad range of innovative products and solutions used primarily by health care professionals in the fields of Johnson & Johnson Medical Devices contains key surgical platforms such as Wound Closure, Orthopedics, Open and Minimally Invasive Stapling, Energy, Biosurgery, Aesthetics, ENT, and Cardiovascular surgical products. As the most comprehensive devices business in the world, Johnson & Johnson Medical Devices is best suited to serve evolving customer needs, train more surgeons to improve standards of care, and treat more patients globally as access expands. Johnson & Johnson Medical Devices is currently $20 billion in World Wide sales. The business is expected to experience solid growth over the next 5 to 7 years.
You, the Senior Manager, Quality Operations (Site Quality Liaison) serves as the on-site Johnson & Johnson Medical Devices (JJMD) representative for the External Strategic Collaborator (ESC). He/she ensures that appropriate communication channels are established and maintained between JJMD and ESC. The Sr. Manager, Quality Operations oversees site activities with potential impact to JJMD product quality, quality management system, and brand integrity. The Sr. Manager, Quality Operations is accountable for ensuring that the ESC has a clear understanding and ability to execute to the JJMD Quality System and the Quality Agreement requirements. Critically, the Sr. Manager, Quality Operations partners with the respective ESC site management team for their sphere of influence to develop and support initiatives and responses to internal quality issues. He/she partners with ESC assessing their Quality System through input to Management Review and Joint Quality Reviews at the ESC and JJMD levels. Further, the Sr. Manager, Quality Operations has the necessary independence, authority and responsibility to communicate quality problems according to the J&J escalation standard and Quality Agreement. The Sr. Manager, Quality Operations is a key member of the JJMD Supply Chain team as well a key partner to the ESC Supply Chain network.
Responsibilities include but are not limited to:
- Oversee execution of the Quality Agreements and Transitional Service Agreements (TSA) between ESC and JJMD.
- Oversee Lot Release Certification and Monitoring Program for JJMD products:
- Establish and maintain training development of lot release activities
- Establish and maintain training development and execution of JJMD quality personnel performing lot release certification and monitoring activities
- Track and analyze lot release certification and monitoring data in order to measure program effectiveness and to identify trends. Report data analysis, including any negative trend, through Management Review and Joint Quality Review.
- Review and approve non-conformances and CAPAs resulting from the lot release certification and monitoring processes, including root cause investigation, product impact assessment, bounding, and applicable corrective action plans.
- Oversees Site JJMD Quality Engineering activities as defined by the Quality Agreement.
- Supervise site JJMD quality organization, including salary and wage associates:
- Evaluate and recommend staffing requirements to ensure maximum utilization of personnel to fulfil department objectives
- Set departmental yearly goals
- Recommend salary increases and promotions for direct reports
- Recruitment and onboarding of new staff
- Conduct performance appraisal, compensation, people development plans, and training curricula
- Approve departmental purchases and personnel company expenses
- Perform team communications
- Promote, terminate, and transfer direct staff, as required
- Collaborate with ESC on escalation decisions as per Quality Agreement
- External audit support for JJMD products and/or quality systems
- Reviews site monthly dashboard and establishes (with ESC) improvement plans to address below target metrics and negative trends.
- Participate of the site Quality System Management Review (QSMR)
- Support Joint Quality Review process
- Support ESC/JJMD Product Focus Teams.
- Provides input into the site Quality Plan & yearly Quality Objectives
- Provide ESC with guidance and connection to JJMD organization towards the resolution of issues and/or improvements related to JJMD Products.
- Serve as a resource by recommending appropriate compliance efforts and proposing improvements to the Quality System.
- Enforces, promotes and observes JJMD Quality System and Quality Agreement requirements.
- Escalate to ESC and JJMD Management issues with potential impact to product quality, regulatory, and/or compliance.
- BS degree in scientific and/or engineering discipline or equivalent
- Requires five (5+) years of related experience in areas such as Quality Operations, Compliance, Quality Systems, Quality Management, Design Quality, etc.
- Minimum of 3 years of supervisory/people management experience is required
- Quality Management experience within J&J and product knowledge is preferred
- Experience with Ethicon Quality Systems is an asset.
- 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.
- Experience in the medical device, pharmaceutical or other highly regulated industry preferred. Knowledge of ISO and/or cGMP regulations is preferred.
- Ability to analyze, balance, and prioritize risk is required
- Must have the following skills: stakeholder management, leadership and management skills, excellent communication and interpersonal relation skills, technical writing, advanced project management skills, and coaching skills.
- Advanced Quality Systems knowledge, interpretation and application of QSR, ISO standards and other relevant global regulations is required.
- The position will require approximately 15% travel both domestically and internationally, depending on the location of the role.
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 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.
United States-New Mexico-Albuquerque
Ethicon Endo Surgery Inc (6041)