Aprilia, Latina, Italy, Italy
Hybrid
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Job Function:
QualityJob Sub Function:
Customer/Commercial QualityJob Category:
ProfessionalAll Job Posting Locations:
Aprilia, Latina, ItalyJob Description:
DePuy Synthes is recruiting for a CQ Specialist QMS/Complaints IT, located in Aprilia, Latina.
Job Overview
The Commercial Quality Specialist, QMS/Complaints IT supports quality management system (QMS) and complaint‑handling activities for commercial operations, with a specific focus on IT‑enabled processes and systems. This role helps ensure compliant, efficient, and accurate handling of complaints and post‑market data in line with regulatory requirements and internal quality standards. The position plays an important role in safeguarding patient safety, strengthening data integrity, and supporting business continuity by partnering closely with Quality, Regulatory Affairs, IT, and Commercial teams.
Key Responsibilities
Support commercial quality activities related to QMS and complaint‑handling processes, including IT‑enabled systems and tools.
Ensure compliant and timely handling of complaints, including documentation, system entries, and coordination of investigations.
Support post‑market surveillance and vigilance activities, including adverse event reporting and field action support as required.
Partner with IT, Quality, and Regulatory Affairs teams to support maintenance, improvement, and validation of complaint‑handling and QMS systems.
Support implementation and adherence to global and local QMS procedures, work instructions, and data governance requirements.
Participate in internal audits, external audits, and health authority inspections related to QMS and complaint systems.
Monitor quality trends, metrics, and system performance related to complaints and QMS data and support corrective and preventive actions.
Maintain accurate quality documentation, reports, and system records related to commercial quality activities.
Qualifications
Education:
Bachelor’s degree in Quality, Engineering, Life Sciences, Regulatory Affairs, Information Systems, or a related discipline (required).
Advanced degree in a scientific, quality, regulatory, or IT‑related field (preferred).
Experience and Skills:
Required:
Typically 2-4 years of experience in Quality, Regulatory, Compliance, or QMS roles within a regulated industry.
Experience supporting complaint‑handling processes and QMS activities.
Foundational understanding of quality system requirements and regulatory expectations for commercial operations.
Experience working with IT‑enabled quality or complaint management systems.
Strong attention to detail, documentation, and data accuracy.
Preferred:
Experience in medical devices, healthcare, or other highly regulated industries.
Familiarity with EU MDR and German regulatory requirements.
Experience supporting audits, inspections, or health authority interactions.
Experience working in a multinational or matrixed organization.
Quality or Regulatory certifications (e.g., ASQ, RAC).
Effective communication and cross‑functional collaboration skills.
Other:
Language: English required; German preferred.
Travel: Limited; occasional domestic or regional travel.
Certifications: Quality or Regulatory certifications 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:
€39,800.00 - €64,055.00
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.
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