Description
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 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 humanity. Learn more at jnj.com.
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:
QualityJob Sub Function:
Customer/Commercial QualityJob Category:
ProfessionalAll Job Posting Locations:
Leeds, West Yorkshire, United KingdomJob Description:
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.
DePuy Synthes is recruiting for a Commercial Quality Specialist - UK/ Ireland located in Leeds, United Kingdom.
Responsible for the execution of Commercial Quality related processes for training, change control, document control and other QMS elements in a flawless and compliant way within the UK / Ireland Local Operating Company (LOC) and Managed Service (JJMS)
Key Responsibilities
Ensure compliance to all applicable quality standards & regulatory requirements in the UK/Ireland LOCs and JJMS.
· Support documentation of the Quality Management System (QMS) processes in the document management system and assist other departments to ensure documents are maintained.
· Support training activities – including maintenance & implementation of the training matrix, development and issuance of training metrics on a regular basis
Own, track and conduct non-conformances and CAPA investigations and document in the appropriate systems using approved tools.
Ability to work alone but part of a virtual team. Work independently to resolve quality issues locally or where applicable with appropriate escalation
Manage & lead change control activities as applicable
Support Monthly metric generation & collate data for Quality Management Review
Act as records coordinator for UK / Irl LOC
Assist in driving continuous improvements, simplification & standardization within the QMS
Execute a culture of compliance and good customer service/feedback.
Ensure compliance with the procedures and processes.
Support & Participate on site audits (e.g. from regulatory bodies)
Collaborate closely with Sales, Customer Service, and Distribution/Returns teams.
Required Experience
1–2 years' experience in Quality, Regulatory, or Compliance within a regulated environment.
Understanding of quality systems and regulatory requirements.
Strong attention to detail and documentation skills.
Excellent written and verbal English communication.
Ability to work independently and cross-functionally.
Strong computer skills (Excel, Word, PowerPoint, Outlook, and business systems).
Customer-focused with strong relationship-building skills.
Preferred Experience
Medical devices, healthcare, pharmaceuticals, or other regulated industries.
Audit, inspection, or regulatory assessment support.
Experience in a multinational or matrix organization.
Exposure to health authority or notified body inspections.
Ideal Candidate Profile
This role would suit someone with early-career quality or regulatory experience who enjoys:
Investigating issues and solving problems.
Working with compliance processes.
Collaborating with multiple stakeholders while maintaining high attention to detail.
Required Skills:
Preferred Skills:
Business Behavior, Compliance Management, Continuous Improvement, Data Analysis, Data Compilation, Detail-Oriented, Execution Focus, Goal Attainment, Internal Controls, Issue Escalation, Process Oriented, Quality Control (QC), Quality Management Systems (QMS), Quality Standards, Regulatory Environment, Report Writing