Transportation & Temp Control EMEA

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:

Quality

Job Sub Function:

Customer/Commercial Quality

Job Category:

Professional

All Job Posting Locations:

Leeds West Yorkshire United Kingdom

Job Description:

DePuy Synthes is recruiting for aTransportation & Temp Control - EMEAlocatedin Leeds West Yorkshire United Kingdom or Ringaskiddy Ireland or Zug Switzerland or Umkirch Germany.

Please note that this role is available across multiple countries and may be posted under different requisition numbers to comply with local requirements. While you are welcome to apply to any or all of the postings we recommend focusing on the specific country(s) that align with your preferred location(s):

St. Anthonys Road Leeds UK - Requisition Number:R-084917

Loughbeg Ringaskiddy or Umkirch Germany - Requisition Number: R-087017

Zug Switzerland - Requisition Number: R-087019

Remember whether you apply to one or all of these requisition numbers your applications will be considered as a single submission.

TheTransportation & Temp Control - EMEAsupports the execution and continuous improvement of regionalCommercialQuality and Safety Surveillance (CQSS) activities across the EMEA region. This role plays a critical part in ensuring compliance with applicable quality system requirements supportingpostmarketsurveillance and vigilance processes and partneringcrossfunctionallytomaintainpatient safety and regulatory readiness. This is an opportunity to contribute directly to product quality regulatory compliance and patient outcomes within a leadingorthopedicsorganization.

Key Responsibilities

• Support EMEA CQSS activities includingpostmarketsurveillance quality system compliance and safety reporting processes in alignment with global and regional requirements.

• Assistin the execution and maintenance of quality system documentation including procedures work instructions and records related to CQSS activities.

• Participate in complaint handling vigilance and trend analysis activities to support identification and escalation of quality and safety issues.

• Support internal and external audits inspections and regulatory inquiries by preparing documentation and responding to information requests.

• Collaborate withcrossfunctionalpartners (e.g. Regulatory Affairs Medical Safety Operations) to supporttimelyinvestigation and resolution of quality and compliance issues.

• Contribute to continuous improvement initiatives byidentifyingopportunities to enhance CQSS processes tools and reporting.

• Maintainaccuratetracking and reporting of CQSS metrics to support management review and regulatory compliance.

Qualifications

Education

• Bachelors degreein a scientific engineering healthcare or related discipline.

• Advanced degree in Quality Regulatory Life Sciences or a related field preferred.

Experience and Skills

Required:

• Typically requires 24 years of relevant work experience in Quality Compliance Regulatory Affairs or a related function within a regulated industry (e.g. medical devices pharmaceuticals).

• Working knowledge of quality systems and compliance requirements (e.g. ISO 13485postmarketsurveillance vigilance).

• Experience supporting investigations documentation and quality recordsin accordance withestablished procedures.

• Strong attention to detail with the ability to manage multiple priorities in a regulated environment.

Preferred:

• Experience supportingEMEAbasedquality vigilance or regulatory activities within the medical device industry.

• Familiarity with EU MDR/IVDRpostmarketsurveillance and safety reporting requirements.

• Experienceparticipatingin audits or health authority inspections.

• Proficiencywith quality systems databases and reporting tools.

• Effective written and verbal communication skills with the ability to collaborate across functions and regions.

Other:

• Languages:Proficiencyin English;additionalEMEA language skills are a plus.

• Travel: Limited regional travel may be(generally upto 10%).

• Certifications: Quality or Regulatory certifications (e.g. ASQ ISO Lead Auditor) preferred but not.

For more information on how we support the whole health of our employees throughout their wellnesscareerand life journey please visit.

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 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.

Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race color religion sex sexual orientation gender identity age national origin disability protected veteran status or other characteristics protected by federal state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.

Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants needs. If you are an individual with a disability and would like to request an accommodation external applicants please contact us via internal employees contact AskGS to be directed to your accommodation resource.

#LI-Hybrid

#DePuySynthesCareers

Required Skills:

Preferred Skills:

Audit Management Business Behavior Coaching Compliance Management Continuous Improvement Data Analysis Detail-Oriented Goal Attainment Internal Controls Issue Escalation Problem Solving Process Oriented Quality Control (QC) Quality Management Systems (QMS) Quality Standards Regulatory Environment

Required Experience:

Contract

Employment Type : Full-Time
Experience: years
Vacancy: 1