Senior Quality Systems Analyst

About the role

The Senior Quality Systems Analyst supports US DePuy Synthes Commercial Quality (CQ), distribution sites, regional functions, and Last Mile field inventory managers. They execute quality system activities, compile and summarize quality data, coordinate document control and training activities, and support compliance activities.

Responsibilities

• Support CQ and business partners on quality systems and compliance activities.
• Compile and summarize quality data for reporting, Data Review Board, and Management Review.
• Cook document control and training activities, including routing, release, assignments, completion monitoring, and records review.
• Maintain quality records, including gap assessments, risk assessments, inspection tools, and related documentation.
• Support nonconformance/CAPA, quality planning, change management, and effectiveness monitoring activities.
• Communicate procedure changes, training requirements, quality expectations, and document updates to cross-functional partners.

Requirements

• Minimum bachelor’s degree required. Preferred degree areas include Engineering, Science, Business, Quality, Regulatory Compliance, or related fields.
• 7 years of relevant work experience in a regulated healthcare, medical device, pharmaceutical, consumer products, distribution, commercial quality, or quality systems environment.
• Experience supporting quality systems, document control, training compliance, quality metrics, audits, nonconformance management, corrective action processes, or related compliance activities.
• Experience using quality system IT platforms such as Windchill, ETQ, DMS, LMS, QEM, Summit, change control systems, ERP systems, warehouse management systems, or related tools preferred.

Qualifications

• Working knowledge of applicable FDA regulations, ISO 13485, ISO 9001, and quality system requirements relevant to commercial distribution and field inventory environments.
• Experience with Microsoft Office, data analysis, and quality system applications.
• Preferred experience with Windchill, ETQ, Summit, ERP or warehouse management systems.
• Preferred data analysis experience includes pivot tables, lookups, Power BI, Tableau, or related visualization tools.
• Preferred experience includes audit preparation, inspection readiness, regulatory responses, or health authority interactions.
• Preferred certifications or training include Lean, Six Sigma, 5S, ASQ, ISO-13485, Good Distribution Practices, supplier quality, or other quality improvement methods.

Skills

• Effective communication and collaboration with cross-functional partners.
• Follow established procedures, complete assigned work accurately and on time, maintain organized records, and escalate issues when needed.
• Apply critical thinking, problem-solving, and root cause analysis to support issue resolution.
• Demonstrate working knowledge of standard quality system requirements and documentation practices.

Pay

The anticipated base pay range for this position is: $94,000.00 - $151,800.00

Benefits

• Consolidated Retirement Plan (pension)
• Savings Plan (401(k))
• 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
• 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