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Job Function
Quality
Job Sub Function
Quality Assurance
Job Category
People Leader
All Job Posting Locations:
Blackpool, Lancashire, United Kingdom
Job Description
About Orthopaedics
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.
As a Quality Engineering Team Leader, You Will Be
Part of the Quality team reporting into the Site Quality Lead (UK), the leader's 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 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 Feedback, Human-Centered Design, Inclusive Leadership, ISO 9001, Leadership, Quality Control (QC), Quality Management Systems (QMS), Quality Standards, Risk Assessments, Standard Operating Procedure (SOP), Team Management