North America CQSS QMS Analyst

The North America CQSS/QMS Analyst supports the effectiveness and continuous improvement of the Quality Management System (QMS) within DePuy Synthes. This role plays a critical part in ensuring compliance with applicable quality system regulations and internal standards while partnering closely with Quality Regulatory Affairs andcrossfunctionalteams. The position offers the opportunity to directlyimpactproduct quality patient safety and regulatory readiness across the North America region by supporting audits metrics and quality system processes.

Key Responsibilities

• Support the maintenance execution and continuous improvement of the Quality Management System (QMS) in alignment with internal procedures and external regulatory requirements.

• Assistwith quality system processes including document control change management CAPA internal audits and management review activities.

• Compile analyze and trend quality data and metrics to support compliance monitoring and leadership reporting.

• Participate in internal supplier and regulatory audits by preparing documentation responding to requests and trackingfollowupactions.

• Supportinspectionreadiness activities and ensuretimelyclosure of audit observations and commitments.

• Collaborate withcrossfunctionalpartners to ensure consistent application of QMS requirements across the organization.

• Contribute toquality system training materials and support training compliance activities.

Qualifications

Education

• Bachelors degree preferably in Engineering Life Sciences Quality or a related technical discipline.

• Advanced degree preferred.

Experience and Skills

Required:

• Approximately 24 years of experience in Quality Compliance or Quality Systems within a regulated environment (medical device pharmaceutical or similar).

• Working knowledge of Quality Management Systems and applicable regulations and standards (e.g. FDA QSR ISO 13485).

• Experience supporting audits inspections or quality system assessments.

• Ability to manage multiple priorities and work effectively in acrossfunctionalenvironment.

Preferred:

• Experience in the medical device industry or orthopedics sector.

• Familiarity with electronic QMS (eQMS) tools and document management systems.

• Experience with CAPA change control and management review processes.

• Prior involvement in regulatory authority inspections or notified body audits.

• Continuous improvement or risk management experience.

• Strong analytical skills with the ability to interpret quality data and metrics.

• Effective written and verbal communication skills.

Other:

• Language: Englishproficiency.

• Travel: Limited; up to 10% domestic travel may be.

• Certifications: ASQ or otherqualityrelatedcertifications preferred but not.

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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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