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

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About MedTech

Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments.

Your unique talents will help patients on their journey to wellness. Learn more at https: //www.jnj.com/medtech

We are searching for the best talent for Supplier Quality Manager.

Purpose:

The Supplier Quality Manager has primary responsibility to provide Supplier Quality Assurance expertise, direction and guidance to the manufacturing businesses, and for supplier control processes within Costa Rica site. This position provides supplier quality support in line with established MD& D and regulatory standards, ensuring purchased finished goods, direct and indirect materials or services are compliant. The Supplier Quality Manager will develop and monitor QA systems to ensure that the company meets its quality objectives with regard to supplier controls.

You will be responsible for:

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

The Supplier Quality Manager will:

• 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 source 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 Source 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 J& J MedTech Costa Rica site 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.
• 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 J& J MedTech Costa Rica SQ Management group.
• Work to ensure supplier engineering resources are prioritized 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.
• Prepares Supplier Quality Agreements at the direction of the Director/Senior Manager
• Leads/assists in the maintenance of the supplier quality relationship (proactive quality reviews, risk-sensing modeling, follow-up on corrective actions, metrics development/improvements, etc.)
• Understands or anticipates the customer’s needs and adds value by providing specific metric information tailored to the particular business environment
• Proactively identifies unmet business needs and takes actions to identify internal/ external customer requirements and translates them into actions with appropriate prioritization and organizational communication
• 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.
  • 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.
  • 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.

Qualifications / Requirements:

Experience and education

• 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 years experience in a managerial capacity is preferred.
• Previous work experience with Suppliers is preferred.

Required knowledge, skills, abilities, certifications/licenses and affiliations

• General Understanding of regulatory compliance requirements (QSR, MDD, ISO 9001, ISO13485, ISO 14971 and other international standards) 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.

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