CQ Specialist QMSComplaints IT
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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:
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 managementsystem(QMS) and complainthandling activities for commercial operations with a specific focus on ITenabled processes and systems. This role helps ensure compliant efficient andaccuratehandling of complaints and postmarket data in line with regulatory requirements and internal quality standards. The position playsan important rolein 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 complainthandling processes including ITenabled systems and tools.
Ensure compliant andtimelyhandling of complaints including documentation system entries and coordination of investigations.
Support postmarket surveillance and vigilance activities including adverse event reporting and field action support as.
Partner with IT Quality and Regulatory Affairs teams to support maintenance improvement and validation of complainthandling 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.
Maintainaccuratequality documentation reports and system records related to commercial quality activities.
Qualifications
Education:
Bachelors degree in Quality Engineering Life Sciences Regulatory Affairs Information Systems ora relateddiscipline (required).
Advanced degree in a scientific quality regulatory or ITrelated field (preferred).
Experience and Skills:
Required:
Typically2-4 years of experience in Quality Regulatory Compliance or QMS roles within a regulated industry.
Experience supporting complainthandling processes and QMS activities.
Foundational understanding of quality system requirements and regulatory expectations for commercial operations.
Experience working with ITenabled 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 crossfunctional collaboration skills.
Other:
Language: English; German preferred.
Travel:Limited; occasional domesticor regionaltravel.
Certifications: Quality or Regulatory certifications preferred but not.
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.
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.
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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 EnvironmentThe anticipated base pay range for this position is:
39800.00 - 64055.00Benefits:
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 locations 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.
Required 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
