Job Description:

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com

DePuy Synthes TECA (Trauma, Extremities, Craniomaxillofacial, Animal Heath) has significant supplier base in EU. This Manager Supplier Quality has primary responsibility to provide Supplier Quality Assurance expertise, direction, and guidance to the DePuy Synthes (DPS) sites and products within the TECA business in the EU. This position provides supplier quality support for direct and indirect suppliers for the sites in line with established DePuy Synthes, MedTech and regulatory standards. Additionally, the position ensures supplier quality oversight for external manufacturers of TECA products. The Manager, Quality Source will develop and monitor QA systems to ensure that the company meets its quality objectives with regard to supplier controls.

duties & responsibilities

In accordance with all applicable federal, state and local laws/regulations and Corporate Johnson & Johnson, procedures and guidelines, this position:

The Supplier Quality Manager will:

• Be responsible for the overall supplier control processes within the DPS Quality Systems
• Lead development, continuous improvement and implementation of supplier control processes for the DPS quality system 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
• 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 the Management teams to meet SQ related objectives
• Provide SQ input to and attend supplier business reviews as required
• Responsible for ensuring the supplier audit schedule is achieved
• Maintain and control the list of approved suppliers for sites within the DPS Quality System
• Maintain and DPS quality system SOPs in support of initial supplier approval and continuous supplier evaluation and in compliance with MedTech and DPS 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 prioritized in support of business and quality aims
• Actively drive all defined Supplier 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 Supplier Quality function as required by management
• Ensure that all Health, Safety and Environmental requirements are fulfilled.
• Maintain detailed and accurate records of all activities

additionally:

• Responsible for communicating business related issues or opportunities to next management level
• Responsible for following all Company guidelines related to Health, Safety and Environmental practices as applicable.
• For those who supervise or manage a staff, responsible for ensuring that subordinates follow all Company guidelines related to Health, Safety and Environmental practices and that all resources needed to do so are available and in good condition, if applicable
• Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures
• Performs other duties assigned as needed

experience and education

Experience:

• A minimum of 8 years progressive Quality, Engineering and/or Operations experience in a regulated industry is required.
• Previous work experience with Suppliers.
• Demonstrated knowledge of business impact of compliance issues and risk management.
• Experience in leadership roles involving project management, problem solving and technical projects.
• This individual is expected to possess high performing skills in negotiating and influencing decision makers, decision making skills, communication skills, judgement, tact and leadership skills.

Education Requirements:

• University/Bachelor’s degree or equivalent in Engineering/Scientific or associated relevant Technical / Engineering discipline is required.
• An Advanced degree in engineering/scientific or discipline is preferred.

REQUIRED KNOWLEDGE, SKILLS, ABILITIES, CERTIFICATIONS/LICENSES and AFFILIATIONS

Interpersonal skills/ characteristics:

• Project Management experience, to include resource management, FTE demand, risk analysis, cost optimization.
• A minimum of three (3) years of people management experience.
• A minimum ten (10) years of relevant experience in medical devices, pharmaceutical industry.
• Experience in Supply Chain and/or R&D.
• Experience with Six Sigma/Process Excellence tools, training and certification.

Required Skills: