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, and cross‑functional teams. The position offers the opportunity to directly impact product 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. 

• Assist with 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 tracking follow‑up actions. 

• Support inspection readiness activities and ensure timely closure of audit observations and commitments. 

• Collaborate with cross‑functional partners to ensure consistent application of QMS requirements across the organization. 

• Contribute to quality system training materials and support training compliance activities. 

Qualifications 

Education 

• Bachelor’s degree , preferably in Engineering, Life Sciences, Quality, or a related technical discipline. 

• Advanced degree preferred. 

Experience and Skills 

Required: 

• Approximately 2–4 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 a cross‑functional environment. 

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: English proficiency . 

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

• Certifications: ASQ or other quality‑related certifications preferred but not . 

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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