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Director, Quality Operations
Requisition ID: 4752180301
DePuy Synthes Companies of Johnson & Johnson is seeking a Director, Quality Operations to be located in Monument, CO.
DePuy Synthes Companies of Johnson & Johnson is the largest, most innovative and comprehensive orthopaedic and neurological business in the world. DePuy Synthes Companies will offer an unparalleled breadth and depth of products, services and programs in the areas of joint reconstruction, trauma, spine, sports medicine, neurological, craniomaxillofacial, power tools and biomaterials. Building on the legacy and strengths of two great companies, we are creating one organization that will be agile and better equipped in today's evolving health care environment. With a focus on activating insights to develop innovative, comprehensive solutions, we are inspired to advance patient care in greater ways than either company could accomplish on its own.
The Director, Quality Operations will ensure the appropriate Quality Operation Leadership is available at all times and skills and competencies are consistent with present and future needs, verifying that Quality Systems are in place to maintain the required compliance level across the manufacturing site, and driving Quality System efficient execution and reduce risk of non-conforming product.
You will work with all Departments within DePuy Synthes, the primary manufacturing site and associated satellite facility’s as well as J&J Corporate Bodies, Notified Bodies and FDA during plant related activities, Equipment representatives and sub-contractors.
The Director, Quality Operations establishes and maintains QS procedures and controls ensuring that performance and quality of the product conforms to established company and regulatory standards. Develops and disseminates strategy for talent attraction, development and retention to enhance the Quality Operation talent pipeline. You will ensure the plant has appropriate resources with the right competencies to execute the Quality System. You'll “champion” cross site and franchise assignments to further Global Quality Leadership development. The Director, Quality Operations will provide active link and partnership between DePuy Synthes sites, franchise partners, regions and corporate functions. He/she will partner with the respective management for their sphere of influence to develop and support initiatives and responses to internal issues. You will foster resource leverage across plants and regions, ensures alignment or harmonization where required and/or appropriate. He/she will execute responses to field actions and coordinates global response with the franchise Quality leadership and corporate functions.
The Director, Quality Operations will ensure the manufacturing plant assesses QS effectively through internal audit and Management review and implements corrective/ preventive, improvement actions as appropriate. We need you to ensure the plant addresses customer feedback and complaints in appropriate and timely manner. You will ensure implementation of Quality Systems and goals are integrated in a cost effective and productive manner. The Director, Quality Operations will establish and monitor metrics for the measurement of Quality indicators and Quality Costs to ensure effectiveness and value to the business. You'll lead the staff in the understanding, development and deployment of key strategies, continuous improvement and customer focus. The Director, Quality Operations will support the plant in the investigation, evaluation and implementation of actions to eliminate root causes of non-conformances. You'll have the necessary independence, authority and responsibility to initiate action to prevent nonconformities, enact remediation plans, identify and document quality problems, initiate, recommend, provide and verify solutions to quality problems and direct or control further processing and delivery of nonconforming product.
The Director, Quality Operations shall perform the role of Management Representative for DePuy Synthes Operations plant, including satellite sites. Act as a key member of the Supply Chain management team for Monument plant. You will be responsible for the recruitment, supervision, training and development of all QA personnel (approximately 65 employees in QA and support of approximate 300 operations employees). You will maintain quality standards and procedures for processing materials into partially finished or finished material or product (machining, inspection, receiving inspection raw and semi-finished product, labelling, laser etch identification, cleaning, packaging, labelling, sterile pack , including responsibility for validation, calibration and metrology activities.
The Director, Quality Operations ensures accurate maintenance of applicable device history files. He/she will oversee the implementation and execution of inspections prior to the processing of raw materials/components, the monitoring of environmental conditions, the validation of all manufacturing and clean/control rooms processes prior to sterilization (as applicable), and the timely management reporting of internal/external quality results with conclusions for all required corrective actions. You will work closely with Operations at manufacturing site and satellite plants in a team based environment to insure process and product compliance with all relevant quality standards, including the formal certification of operations personnel to perform quality related inspection/audit activities. The Director, Quality Operations will ensure new products are transferred into routine production effectively with all development documentation completed. He/she will be responsible for the disposition of products or materials that do not meet standards and specifications. You will ensure active participation and support for all Health & Safety related activities. Also, he/she will ensure that all Health & Safety requirements are fulfilled in accordance with the responsibilities defined in the Company Safety Statement, as well as actively promote Health & Safety within the department and ensure Health & Safety is a goal for all direct reports.
The Director, Quality Operations is responsible for ensuring a systematic control of documents for the manufacturing site, as well as ensuring document control of all HSE procedures. He/she will ensure audits are conducted in accordance with requirements of ISO 13485, FDA QSR 21 CFR Part 820 or other recognized regulatory standards for all markets in which our products are sold. The Director, Quality Operations will be the Management Representative for the DePuy Synthes manufacturing site and satellite manufacturing plants. You will review and investigation of complaints for product manufactured at manufacturing plant and Quality System Activities within facility. He/she will provide Resolution of Quality issues within the manufacturing site, and associated satellite facilities.
- A minimum of a Bachelor Degree is required.
- A Bachelor Degree in and Engineering or Science Discipline is preferred.
- A minimum of 10 years’ experience in a GMP and/or ISO regulated industry is required.
- Medical device industry experience is preferred.
- A minimum of 5 years of direct people management experience is required.
- Experience in Project Management; Risk Management; Budget management; Quality Auditing; Operations Processes; Systems Development & Integration are required.
- Strong business acumen, interpersonal and performance management skills for a highly global matrix organization and teams with diverse cultures and business practices is required.
- Strong verbal and written communications skills for multi-level stakeholders, including the ability to negotiate win-win solutions to drive standardization are required.
- Ability to interact with, influence, and lead cross-functional, cross-business unit teams is required.
- Strong strategic planning and tactical execution abilities, including strong organization skills is required.
- The ability to take initiative regarding innovative approaches to problem solving in a fast-paced, changing business environment is required.
- Process Excellence and Lean experience desired.
This position will be based in Monument, CO and will require up to 10% travel, including potential international.
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 areequal opportunity employers, and all qualifiedapplicants will receive consideration for employmentwithout regard to race, color, religion,sex, sexual orientation, gender identity, geneticinformation, national origin, protected veteranstatus, disability status, or any othercharacteristic protected by law.
Depuy Orthopaedics. Inc. (6029)