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.
Reporting to the DePuy Synthes Supplier Quality Director, the Supplier Quality Manager has primary responsibility to provide Supplier Quality Assurance expertise, direction and guidance to the DePuy Synthes manufacturing plants in Cork, Blackpool and Leeds and for supplier control processes within these sites.
This position provides supplier quality support in line with established DePuy Synthes, J&J and regulatory standards. The Supplier Quality Manager will develop and monitor QA systems to ensure that the company meets its quality objectives with regard to supplier controls.
The Supplier Quality Manager responsibilities will include;
• Lead development, continuous improvement and implementation of supplier control processes within responsible Quality System’s that meet regulatory requirements and align with J&J standards.
• Recruit, develop and manage the DePuy Synthes supplier quality team to ensure a high performing team to achieve the groups objectives
• Provide Quality Engineering support to suppliers including inspection technique support, product non-conformances, verification/validation activities, CAPA and change management.
• Ensure effective and timely investigation and closure of all CAPA’s, Supplier Non Conformances, complaints, product issues.
• Lead Supplier Quality input to site management reviews
• Partner with Business R&D and Design Quality to ensure new product sourcing and supplier controls are implemented in line with business and J&J requirements
• Supports third party assessments at both DePuy Synthes and suppliers.
Provide Quality Leadership in support of supplier and External Manufacturing Outsourcing programs and product transfers to suppliers
Partner with site Management teams to meet site SQ related objectives
Provide SQ input to and attend supplier business reviews as required
Responsible for ensuring the supplier audit schedule is achieved
Drive a standardised approach by leading the Supplier Management Committee meetings for responsible sites
Maintain and control the list of approved suppliers for sites within responsible sites
Maintain and control company SOPs in support of initial supplier approval and continuous supplier evaluation and in compliance with MD&D Supplier quality requirements
Maintain supplier management documentation and records to ensure they are complete and current
Promote continuous improvement and Process Excellence activities within the DePuy Synthes Supplier Quality Management group
Work to ensure supplier engineering resources are prioritised in support of business and quality aims
Actively drive all defined Supplier and External Manufacturing Quality Systems goals and objectives.
Design and validate Quality System processes where appropriate
Participate in design evaluations where appropriate
Resolve problems & eliminate constraints to ensure project and supply targets are met.
Generate Quality metrics on supplier performance and establish measures to monitor quality
Maintain standards of housekeeping & GMP requirements
Represent the Supply Process Quality Assurance function as required by management
Ensure that all Health, Safety and Environmental requirements are fulfilled.
Maintain detailed and accurate records of all activities
• A minimum of a Bachelor’s degree in engineering/scientific or associated relevant technical / engineering discipline is required.
• An Advanced degree in engineering/scientific or discipline is preferred.
• A minimum of 5 years progressive quality, engineering or operations experience in a regulated industry is required.
• A minimum of 2 year’s experience in a managerial capacity is preferred.
• Previous work experience with Suppliers is preferred.
• Demonstrated knowledge of business impact of compliance issues and risk management is required.
• Experience in leadership roles involving project management, problem solving and technical projects is required.
• This individual is required to possess high performing skills in negotiating and influencing decision makers, decision making skills, communication skills, judgement, tact and leadership skills.
• This position can be located at a DePuy Synthes site in Cork, Leeds or Blackpool and will require up to 40% travel.
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