Johnson & Johnson Medical Devices, (J&J MD), a division of the Johnson & Johnson Family of Companies, is recruiting for a Source Quality Senior Manager Direct Materials located in Suzhou, China
The Johnson & Johnson Medical Devices sector represents more than 60 manufacturing sites and 26,000 employees who plan, source, manufacture and deliver high-quality and cost-effective medical products to our customers around the globe each day. The organization supports a multitude of product platforms, technologies, new products and delivery systems.
Reporting to the Senior Director, Source Quality (Direct Materials), the Source Quality Senior Manager has primary responsibility to provide global supplier quality assurance expertise, direction and guidance in the development, implementation and continuous improvement of Source Quality programs associated with the management of external manufacturers. This position will provide Source Quality support in line with established J&J MD, industry and regulatory standards (e.g. QSR, ISO, EN, and Medical Device Directive (MDD) requirements). The Source Quality Senior Manager will develop and monitor QA systems to ensure that all Direct Materials meet their quality objectives with regards to supplier, process and product controls.
The Senior Manager of Source Quality will:
• Be responsible for the overall quality activities, including purchasing controls, associated with external manufacturers
• Lead development, continuous improvement and implementation of purchasing control processes for responsible external manufacturers that meet regulatory requirements and align with J&J MD standards.
• Recruit, develop and manage a high performing source quality team to achieve the group’s objectives
• Provide people leadership to a group of Source Quality professionals focused on developing people, both technical and people-based skills, and ensuring that those competencies match both the quality and business needs. Promotes diversity. Accountable for ensuring goals and objectives are met.
• Holds self and people accountable for results achieved through Credo Values and Leadership Imperatives. Removes barriers to people development. Models and fosters people development. Actively champions and supports people development to expand their capabilities, skills, knowledge and enable movement of talent.
• Provide Source Quality Engineering support to external manufacturers including inspection technique, product non-conformances, verification/validation activities, CAPA and change management.
• Ensure effective and timely investigation and closure of all CAPA’s, Non Conformances, complaints, product issues.
• Lead Source Quality input to site management reviews and product/process escalations.
• Supports third party assessments at both External Manufacturers and sub-tier suppliers.
• Provide Quality Leadership in support of External Manufacturing Outsourcing programs and product transfers
• Partner with site Management teams to meet site Source Quality related objectives
• Provide Source Quality input to and attend quality/business reviews as required
• Responsible for ensuring the supplier audit schedule is achieved
• Drive a standardised approach by chairing supplier management meetings, supplier performance monitoring and joint supplier collaboration sessions.
• Maintain and control the approved supplier list for responsible sites.
• Maintain and control company SOPs in support of initial supplier approval and continuous supplier evaluation and in compliance with J&J MD Source Quality requirements
• Maintain supplier management documentation and records to ensure they are complete and current
• Promote continuous improvement and Process Excellence activities within the Source Quality Management group
• Work to ensure supplier quality engineering resources are prioritized in support of business and quality aims
• Actively drive all defined Direct Materials Quality Systems goals and objectives.
• Design and validate Quality System processes where appropriate
• Participate in design evaluations where appropriate
• Resolve problems and 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 and 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 8 years progressive experience in a regulated industry like Medical Devices, Pharma and/or Consumer is required. A minimum of 4 years experience in a managerial capacity is required. Previous work experience with Suppliers is required. 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 is located in Suzhou, China and will require up to 40% travel, including some international.
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Johnson & Johnson Medical Suzhou Ltd. (7054)