CQ Specialist QMS/Compliants

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Job Function:
Quality

Job Sub Function:
Customer/Commercial Quality

Job Category:
Professional

All Job Posting Locations:
Prague, Czechia, Warsaw, Masovian, Poland

Job Description:

DePuy Synthes is recruiting for a CQ Specialist QMS/Compliants, located in Warsaw Poland.

Job Overview

The CQ Specialist, QMS / Complaints plays a critical role within QARA International by supporting the effectiveness and compliance of the Quality Management System (QMS), focusing on    end ‑ to ‑ end   handling of product complaints, vigilance, field action/recall and supporting the execution of other QMS elements. This role directly supports patient safety, regulatory compliance, and continuous improvement across DePuy Synthes’ international markets. The position offers strong exposure to global and local quality processes,   cross ‑ functional   collaboration, and regulated medical device environments.

Key Responsibilities

- Support the execution and maintenance of the Quality Management System (QMS) in alignment with internal procedures and applicable global regulations.

- Process, document, and track product complaints   in accordance with   regulatory and internal requirements, ensuring   timely   and   accurate   resolution.

- Support complaint investigation activities, including data collection, trend analysis, documentation of findings, and follow-up of required actions.

- Support regulatory reporting activities related to complaints, adverse events, and vigilance requirements, as applicable.

- Support Field Actions, Recalls, and other post-market quality activities by   maintaining   documentation, tracking actions, and supporting execution   in accordance with   internal and regulatory requirements.

- Maintain   accurate   quality records and ensure data integrity within quality systems and databases.

- Support the execution of other QMS elements and quality processes as assigned,   in accordance with   company procedures.

- Participate in audits, inspections, and internal assessments by preparing documentation and supporting responses.

- Analyze   complaint   and quality data to   identify   trends, gaps, potential risks, and opportunities for continuous improvement within complaint and QMS processes.

- Collaborate with cross-functional partners, including Manufacturing, R&D, Regulatory Affairs, and Customer Service, to support quality outcomes and effective issue resolution.

- Contribute to continuous improvement initiatives that strengthen QMS effectiveness, regulatory compliance, patient safety, and product quality.

Qualifications

Education

- Bachelor’s degree   required   in a scientific, engineering, quality, or related discipline.

- Advanced degree in Quality, Regulatory, or Life Sciences preferred.

Experience and Skills

Required:

- Typically   0–2 years of professional experience in Quality, Regulatory, Compliance, or a regulated industry environment.

- Foundational knowledge of Quality Management Systems and controlled documentation.

- Strong attention to detail and ability to manage quality records accurately.

- Ability to analyze data,   identify   trends, and support   root ‑ cause   activities at a basic level.

- Effective written and verbal communication skills.

Preferred:

- Experience supporting medical device or pharmaceutical complaint handling processes.

- Familiarity with global quality and regulatory standards (e.g., ISO 13485, FDA QSR, EU MDR).

- Experience working with electronic QMS or complaint management systems.

- Experience in an international or matrixed organization.

Other:

- Languages:   Proficiency   in English   required ; Polish   required   for local operations.

- Travel: Minimal travel   anticipated   ( generally < 10%, international as needed).

- Certifications: Quality or Regulatory certifications (e.g., ASQ)   preferred   but not   required .

For more information on how we support the whole health of our employees throughout their wellness,   career   and life journey, please visit   www.careers.jnj.com .

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.

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 https://www.jnj.com/contact-us/careers, internal employees contact AskGS to be directed to your accommodation resource.

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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

The anticipated base pay range for this position is:
zł121,000.00 - zł194,350.00

Benefits:

In addition to base pay, we offer the following benefits*: an annual bonus with set target (% of pay) depending on pay grade / location, where the actual amount is based on the employees’ and companies’ performance of the previous calendar year, or sales commissions. Moreover, we offer vacation days, parental leave for a minimum of 12 weeks, bereavement leave, caregiver leave, volunteer leave, well-being reimbursement, programs for financial, physical and mental health. We also offer service anniversary and recognition awards, and subject to the terms of their respective plans, employees - and in some location’s eligible dependents - can participate in several insurance plans. For more information, visit Employee benefits | Supporting well-being & career growth | Johnson & Johnson Careers.

*This is for informative purposes only. Amounts and actual benefits may vary by location and are subject to change.