Job description

Requirements

  • Entry level
  • No Education
  • Salary to negotiate
  • Warsaw

Description

The Medical Devices segment produces a broad range of innovative products used primarily by health care professionals in the fields of orthopaedics, neurovascular, surgery, vision care, diabetes care, infection prevention, cardiovascular disease, sports medicine, and aesthetics. This segment is comprised of our Global Medical Solutions, Global Orthopaedics and Global Surgery Groups.
 
Quality Assurance Leader
Location: Warsaw, Poland
Contract: Permanent
Ref no. 1805700292W
 
We are looking for a Quality Assurance Leader who will be part of Quality team in cross-sector Distribution Center in Poland within CEE region of Deliver organization. Distribution Center is responsible for distribution of medicinal products/medical devices. Other processes within Distributions Center: repack-relabel of products, decontamination of Instruments sets. The role may have specific country responsibilities within processes for products distributed in Poland and e.g. Baltics.
 
Main responsibilities:
Support compliance to all applicable quality standards & regulatory requirements, attending the timely and effective deployment of J&J Standards requirement
Supervise GxP Documentation: updating, distribution, archiving and accepting/approval process including gap assessment and  implementation of corporate quality standards or law requirements
Activities in scope of Quality Management System including corrective and preventive actions (CAPA) process, deviations, complaints, document management, change control, training management, validation/qualification, quality planning and quality KPI reporting and other quality processes based on Quality Management System requirements
Improvement of Quality System in line with J&J/MD strategies & initiatives
Perform quality investigation, root cause analysis, define and track corrective & preventive actions and mitigation/remediation plans for deviations & internal /external audits (notified Bodies, Health Authorities etc.), JJRC audits
Attend an Audit Program playing role of auditor or auditee for an assigned area
Attend Field Actions and Complaints management and coordinating with Customer Service, Business Quality J&J Franchise requirements (as applicable)
Participation in activities in scope of supplier qualification program including establishing Quality Agreements with suppliers
Support Training program with respect to Quality System elements, including training to organization on Quality relevant topics
Attend Quality processes within Quality Management according to principles in the country’s organization & drive continuous improvement
Coordinate quality project according to quality goals with performance monitoring and effective communication within organization
Demonstrate Leadership behaviors expected by J&J Credo and Leadership Principals
Maintain current knowledge of regulatory changes through industry publications, seminars, trainings
Additional travel within EMEA may be required occasionally.


Qualifications
Qualifications:
Bachelors or Master’s degree in Bioscience, Engineering or Business or equivalent field coupled with relevant business experience in Quality leadership roles
3+ years working experience in function with assigned responsibility in quality/regulatory area
Experienced in Internal/external audits
Track record of leading projects
Change management experience and influencing and interpersonal skills
Experience working in a global or regional context would be desired
Strong collaboration skills and ability to build partnerships internally and externally
Advanced level in written and oral English communication skills are required
Ability to effectively present information to internal/external partners including Management level
High Quality System knowledge and understanding of Regulatory Compliance requirements for relevant market, business partnership meaning within organization
We Offer:
An opportunity to be part of a global market leader
A dynamic and inspiring working environment
Many opportunities to work on challenging projects and assignments
Possibilities for further personal as well as professional development
Many employee benefits
 


Primary Location
Poland-Mazowieckie-Warsaw-
Organization
Johnson & Johnson (Poland) Sp. z.o.o. (7815)
Job Function
Validation
Requisition ID
1805700292W

About the company

If you’re thinking about taking your career to a place where you can be seen for the talent you bring to your work, where you’ll have a chance to be the driver of your own career, and where others share your passion for caring and success, then we invite you to explore Johnson & Johnson. BE VITAL in your career and make a unique mark. Join the approximately 129,000 men and women who work within our companies and touch the lives of more than a billion people around the world every day.

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