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Job Function: Supply Chain Engineering
Job Sub Function: Quality Engineering
Job Category: People Leader
All Job Posting Locations: Raynham, Massachusetts, United States of America, Ringaskiddy, Cork, Ireland
Job Description:
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.
SECTION 2: DUTIES & RESPONSIBILITIES
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:
Equipment and Process Transfer & Qualification
1. Lead Quality Project planning, including development and execution of Transfer Quality Plan
2. Support Regulatory submissions and inspections as required
3. Support planning & execution of equipment qualification activities
4. Conduct and/or participate in troubleshooting and/or deviation investigation efforts during project execution
5. 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.
Metrology / Inspection
1. Lead inspection planning activities to ensure all Critical to Quality (CtQ) features are verified with appropriate, qualified inspection and test methods.
2. Review/analyze the effectiveness of current metrology equipment / techniques.
3. Conduct technical benchmarking of new technology to develop more effective methods for improving quality impacted by metrology.
4. Develop, interpret and implement appropriate process inspection and control methods consistent with the level of process/product risk
5. Supports cross-site technical development of metrology engineering, quality compliance, quality leadership talents with the right skill sets for new product introductions, and product life cycle management.
6. Support Quality process knowledge transfer activities.
People
1. Provides supervision, mentoring, coaching, performance review, developmental plans, and succession planning for others as assigned (including Quality Engineers and Technicians).
2. Partner with cross-functional partners to ensure completion of activities in alignment with project strategy and timeline.
3. Timely escalation of risks and emerging issues to project leadership.
Comply with all environmental, safety and occupational health policies (i.e., ISO14001 & OSHAS 18001)
Responsible for communicating business related issues or opportunities to next management level.
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. Ensure QA Department comply with Department Spending and deliver Cost improvement Projects (CIP).
Ensure talent development of direct reports, including but not limited to Certifications and Trainings.
Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures.
Performs other duties assigned, as needed.
SECTION 3: EXPERIENCE AND EDUCATION
1. Bachelor’s Degree in Science, BS in Engineering preferred.
2. A minimum 10 years of related experience in a regulated environment.
3. 3+ years of supervisory experience.
4. Experience in the Medical Device industry or medical field.
5. Ability to work cooperatively with coworkers and the public.
SECTION 4: REQUIRED KNOWLEDGE, SKILLS, ABILITIES, CERTIFICATIONS/LICENSES and AFFILIATIONS
1. ASQ Certified Quality Auditor (CQA) preferred, or ISO Certified Lead Auditor preferred.
2. Advanced computer skills and use of software application(s).
3. Strong technical writing skills are required.
4. Leadership and management skills.
5. Interpretation and application of QSR and ISO Standards.
6. Excellent communication and interpersonal relation skills.
7. Statistical and analytical problem solving.
SECTION 7: RESPONSIBILITY FOR OTHERS & INTERNAL INTERACTIONS
1. This position is responsible and will directly manage and supervises Quality Engineers (different levels and pay Grades), Quality Team Leaders, Quality Technicians, and/or non-exempts associates in day to day activities supporting manufacturing lines, operator certification program, incoming and finished goods inspections, laboratory and CME environmental monitoring, all in accordance with applicable regulations.
2. This position reports to Site Quality Lead.
3. Supports internal and external Health Authorities Audits.
Some potential internal interface activities that the position may encounter are (but not limited to):
1. Assists Site Quality Lead in the preparation of the Performance/Potential Appraisals for the Quality Operations related functions.
2. Acts as a designated Site Quality Lead when needed.
3. Actively supports other Plant functions in the implementation of company programs and projects.
4. Support validations as required.
5. Provides support to Plant wide initiatives.
SECTION 8: LOCATION & TRAVEL REQUIREMENTS
1. Location: Cork Ireland or Raynham US
2. Travel: This position has travel requirements between 15-20%
SECTION 9: EXTERNAL INTERACTIONS
1. Interact effectively with business leaders at regional and corporate levels, auditors from notified bodies, government representatives, and other key stakeholders.
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