DePuy Synthes Companies of Johnson & Johnson is seeking a Director of Quality to be located in Palm Beach Gardens, FL.
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 of Quality 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. Interfacing with all Departments within DePuy Synthes, the primary manufacturing site as well as J&J Corporate Bodies, Notified Bodies and FDA during plant related activities, Equipment representatives and sub-contractors.
• Perform the role of Management Representative for Anspach Organizaiton: Palm Beach Gardens site.
• Establishes and maintains QS procedures 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 talent pipeline. Ensure the plant has appropriate resources with the right competencies to execute the Quality System.
• Provide active link and partnership between DePuy Synthes sites, franchise partners, regions and corporate functions.
• Partner with the respective management for their sphere of influence to develop and support initiatives and responses to internal issues.
• Execute responses to field actions and coordinates global response with the franchise Quality leadership and corporate functions.
• Ensure the manufacturing plant assesses QS effectively through internal audit and Management review and implements corrective/ preventive, improvement actions as appropriate.
• Ensure the plant address customer feedback and complaints in appropriate and timely manner.
• Ensure implementation of Quality Systems and goals are integrated in a cost effective and productive manner.
• Establish and monitor metrics for the measurement of Quality indicators and Quality Costs to ensure effectiveness and value to the business.
• Lead the staff in the understanding, development and deployment of key strategies, continuous improvement and customer focus.
• Support the plant in the investigation, evaluation and implementation of actions to eliminate root causes of non-conformances.
• This individual has the necessary independence, authority and responsibility to initiate action to prevent nonconformities, 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.
• Be a key member of the Supply Chain and Franchise management team for Palm Beach Gardens’ plant as well as a key partner to the Orberdorf Design and Development team.
• Responsible for the recruitment, supervision, training and development of all QA personnel, approximately 40 QA associates.
• Individual will work closely with R&D and Operations 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.
• Ensure new products are Designed and transferred into routine production effectively with all development documentation completed.
• Ensure active participation and support for all Health & Safety related activities.Qualifications
• A minimum of a Bachelor Degree is required.
• A minimum of 10 years’ experience in a GMP and/or ISO regulated industry
• A minimum of 5 years of direct people management experience
• Medical device experience is strongly preferred
• Experience interfacing with FDA and Regulatory/Notified Body agencies in Audits
• Strong business acumen, interpersonal and performance management skills for a highly global matrix organization and teams with diverse cultures and business practices
• Strong verbal and written communications skills for multi-level stakeholders, including the ability to negotiate win-win solutions to drive standardization
• Ability to interact with, influence, and lead cross-functional, cross-business unit teams
• Strong strategic planning and tactical execution abilities, including strong organization skills
• Experience in Project Management; Risk Management; Cost Accounting Principles; Quality Auditing; Operations Processes; Systems Development & Integration
• This position will be based in Palm Beach Gardens, FL and will require up to 15% travel, including potential international.
• A Bachelor Degree in an Engineering or Science Discipline.
• Medical device industry experience
• 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
United States-Florida-Palm Beach GardensOrganization
Depuy Orthopaedics. Inc. (6029)Job Function