North America CQSS QMS Analyst

Johnson & Johnson Innovative Medicine • Mooresville, IN

17h • $79,000 - $142,000 • Hybrid

About The Position

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.

Requirements

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

Nice To Haves

• Advanced degree 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.
• ASQ or other quality‑related certifications preferred but not required.

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.

Benefits

• Vacation –120 hours per calendar year
• Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado –48 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year
• Holiday pay, including Floating Holidays –13 days per calendar year
• Work, Personal and Family Time - up to 40 hours per calendar year
• Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child
• Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
• Caregiver Leave – 80 hours in a 52-week rolling period
• Volunteer Leave – 32 hours per calendar year
• Military Spouse Time-Off – 80 hours per calendar year

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level