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SECTION 1: JOB SUMMARY

Under the direction of the Director of Quality Projects and with the objective of maintaining high quality standards for the product manufacturing process and in compliance with regulatory requirements, provides leadership, technical support and direction to Plant Operations, Technical Operations and Quality Assurance. Directly supervises Quality Engineers (different levels/pay grades), Quality Team Leaders, Quality Technicians and/or non-exempts associates in day to day activities supporting manufacturing transfers, operator certification program, incoming and finished goods inspections; all in accordance with applicable regulations. Provide support and expertise on problem solving, process improvements and in the usage of quality tools.

EQUIPMENT AND PROCESS TRANSFER & QUALIFICATION

• Lead Quality Project planning, including development and execution of Transfer Quality Plan
• Support Regulatory submissions and inspections as required
• Support planning & execution of equipment qualification activities
• Conduct and/or participate in troubleshooting and/or deviation investigation efforts during project execution
• Document, justify, review or analyze whether a proposed change to a process will not enhance the risk level in some way beyond capability of current controls or whether change will result in potential non-compliance to a required standard.

SECTION 3: EXPERIENCE AND EDUCATION

• Bachelor’s Degree in Science, BS in Engineering preferred.
• A minimum 10 years of related experience in a regulated environment.
• 3+ years of supervisory experience.
• Experience in the Medical Device industry or medical field.
• Ability to work cooperatively with coworkers and the public.

SECTION 4: REQUIRED KNOWLEDGE, SKILLS, ABILITIES, CERTIFICATIONS/LICENSES AND AFFILIATIONS

• ASQ Certified Quality Auditor (CQA) preferred, or ISO Certified Lead Auditor preferred.
• Advanced computer skills and use of software application(s).
• Strong technical writing skills are required.
• Leadership and management skills.
• Interpretation and application of QSR and ISO Standards.
• Excellent communication and interpersonal relation skills.
• Statistical and analytical problem solving.

SECTION 8: LOCATION & TRAVEL REQUIREMENTS

• Location: Cork Ireland or Raynham US
• Travel: This position has travel requirements between 15-20%

Under the direction of the Director of Quality Projects and in alignment with all federal, state, and local laws and Johnson & Johnson corporate guidelines, your responsibilities will include: