Quality Engineering Team Leader

At Johnson & Johnsonwe believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented treated and curedwhere treatments are smarter and less invasive andsolutions are 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 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:

Job Sub Function:

Job Category:

All Job Posting Locations:

Job Description:

About Orthopaedics

Fuelled by innovation at the intersection of biology and technology were 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 thats 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 Synthes is recruiting for a Quality Engineering Team Leader located in Blackpool Lancashire.

As a Quality Engineering Team Leader you will be:

Part of the Quality team reporting into the Site Quality Lead (UK) the leaders responsibilities are critical to maintaining site validation activities to maintain a ready state of compliance and providing daily support to the operations team.

The responsibilities and the impact YOU will have:

• 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.

We would love to hear from YOU if you have the following essential 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.

Preferred:

• 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 ISO13485 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 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: