Quality Engineering Team Leader

Overview

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 Med Tech, 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

As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

Job Function: Quality

Job Sub Function: Quality Assurance

Job Category: People Leader

Location: Blackpool, Lancashire, United Kingdom

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

Are you passionate about improving and expanding the possibilities of Orthopaedics? Ready to join a team that’s reimagining how we heal? Our Orthopaedics teams help keep more than 6 million people moving each year while delivering clinical and economic value to surgeons and healthcare systems. Our teams build solutions for joint reconstruction; trauma and craniomaxillofacial; sports, extremities, and elective foot and ankle;

spine; and robotics and digital surgery.

Your unique talents will help patients on their journey to wellness. Learn more at

DePuy Synthes is recruiting for a Quality Engineering Team Leader located in Blackpool, Lancashire.

• Lead a team of Quality Engineers accountable for the compliance of all manufacturing processes.
• Lead projects intended to identify and implement process improvements within the area.
• Own the quality activities for all product and process validation at DePuy Synthes, Blackpool. Develop and maintain innovative protocols and procedures and ensure accurate implementation across site. Provide technical expertise for all areas on relevant IQ/OQ/PQ protocol issues.
• Provide the Quality support for New Product Development activities ensuring Quality aspects of process design is addressed. Document and maintain in good order all relevant sections of Device Design History File and DMR as the need arises.
• Develop and utilise QA risk analysis techniques to minimise potential risk during development/ implementation activity. Work with Production and Engineering to develop and implement appropriate process control plans.
• Partner with Supplier Quality, Engineering, and Purchasing to ensure that all Supplier generated products and components meet requirements.

• Minimum educational level of Degree or equivalent in a relevant science or engineering subject area.
• Extensive experience within Quality or Process Engineering.
• Proactive leader, an effective leader of the QE team with relevant experience in all areas within the QE role.
• Ability to communicate & present (in all its forms) and co-operate effectively at all levels across the organization.
• Well-developed interpersonal skills and people development skills.
• Detail focused with excellent time management.
• Work as a team to deliver to a plan, cope with multiple tasks, and react to changing requirements.

• Customer Focus:
  Results & Performance Driven
• Innovative Solutions:
  Big Picture Orientation with Attention to Detail & Intellectual Curiosity.
• Talent Development:
  Collaboration & Teaming & Self-Awareness & Adaptability.

This position requires an in-depth knowledge of both Quality, Compliance and Validation, in alignment with ISO
13485, FDA regulations and the EU Medical Devices Regulation.

Johnson & Johnson announced plans to separate our Orthopaedics business to establish a standalone Orthopaedics company, operating as DePuy Synthes. The process of the planned separation is anticipated to be completed within 18 to 24 months, subject to legal requirements, including consultation with works councils and other employee representative bodies, as may be required, regulatory approvals and other customary conditions and approvals.

Should you accept this position, it is anticipated that, following conclusion of the transaction, you would be an employee of DePuy Synthes and your employment would be governed by DePuy Synthes employment processes, programs, policies, and benefit plans. In that case, details of any planned changes would be provided to you by DePuy Synthes at an appropriate time and subject to any necessary consultation processes.

Required Skills:

Preferred

Skills:

Business Savvy, Compliance Management, Corrective and Preventive Action (CAPA), Cross-Functional Collaboration, Developing Others, Fact-Based Decision Making, Give…