DePuy Synthes Commercial Quality Specialist| Johnson & Johnson| MedTech
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Job Summary
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:
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 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 product complaints and Field actions in a flawless and compliant way within the Marketing/Local Operating Company (LOC)
Ability to work alone but also work effectively as part of a team
Dealing with complaint escalation prior to further escalations establishing the details and investigating next steps
Management & SME of UK/Ireland Product complaints
Take responsibility for and effectively manage the Field Action processes
Work independently to resolve quality issues locally or where applicable with appropriate escalation
Responsible for the initiation of a Field Actions in LOC including EMEA initial communication calls & taking the lead and arranging LOC stakeholder calls.
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.
Participate in quality/compliance/regulatory project for the complaints and field action process
Responsible for data management within the MHRA MORE portal as required
Ensure working to quality requirements at all times
Support & Participate on site audits (e.g. from regulatory bodies)
Participate / Execute the quality training program for the complaints & Field action process - induction and refresher training where appropriate to the cross functional partners
Identify & Assist with non conformance investigations quality issues and escalation adverse events
Assist with establishing corrective & preventive actions to mitigate potential or actual non conformances
Key Responsibilities
Manage and serve as SME for product complaints in the UK and Ireland.
Lead and coordinate Field Action activities and communications.
Investigate and resolve quality issues with appropriate escalation.
Support quality management system (QMS) compliance and continuous improvement initiatives.
Ensure adherence to quality regulatory and compliance requirements.
Manage data within the MHRA MORE portal.
Support audits inspections training CAPAs non-conformance investigations and adverse event escalations.
Collaborate closely with Sales Customer Service and Distribution/Returns teams.
Required Experience
12 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.
Product complaints and field action management.
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.
Managing product complaints and recalls/field actions.
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 WritingRequired Experience:
IC
About Company
About Johnson & Johnson A t Johnson & Johnson, we believe good health is the foundation of vibrant lives, thriving communities and forward progress. That’s why for more than 130 years, we have aimed to keep people well at every age and every stage of life. Today, as the world’s larges ... View more
