Sr Quality & Compliance Specialist
About The Position
Johnson & Johnson is currently recruiting for a Senior Quality & Compliance Specialist! This role can be performed fully remote throughout the US. Remote work may be considered on a case-by-case basis and if approved by the business. Position Summary: The Senior Commercial Quality Specialist is responsible for the development, execution and oversight of Quality and Compliance (Q&C) programs for the orthopedic last mile operations network within the United States. This may include internal and external orthopedic last mile Field Inventory operations, Loaner Sites, and Distribution Centers (DC) supporting delivery of Field Inventory & surgical loaner sets to orthopedic customers across the US. This position resides in the DePuy Synthes Commercial Quality Major Markets Organization. This position collaborates with and serves as a liaison between Quality, Supply Chain, Deliver, Sales and Commercial partners on distribution and commercial quality related matters to drive timely resolution of quality related issues. This position identifies and supports implementation of improvement opportunities consistent with DePuy Synthes business objectives and applicable regulations. The Senior Quality and Compliance Specialist initiates and supports proposals and programs designed to ensure effective and consistent processes with established standards by performing the following duties personally or through work stream groups.
Requirements
- A minimum of a Bachelors or equivalent University degree is required.
- 6-7 years of relevant work experience in a regulated healthcare, medical device, pharmaceutical, consumer products, distribution, commercial quality, or quality systems environment.
- Working knowledge of applicable FDA regulations CFR 820, ISO 13485, ISO 9001, and quality system requirements relevant to medical devices, commercial distribution and field inventory environments.
- Experience supporting quality systems, document control, training compliance, quality metrics, audits, nonconformance management, corrective action processes, or related compliance activities.
- Communicate and collaborate effectively 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, good documentation practices, technical writing, Nonconformance, CAPA .
- Use Microsoft Office, data analysis and quality system applications
Nice To Haves
- 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.
- Preferred experience with Windchill, ETQ, Summit, ERP or warehouse management systems.
- 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.
Responsibilities
- Define, implement, and validate quality requirements and systems to meet departmental strategies.
- Serve as single point of contact for assigned operations.
- Host and lead audits, inspections, investigations, and remediation activities.
- Ensure the Quality program maintains regulatory compliance.
- Provide quality support for existing and new distribution processes and go to market models.
- Development, implementation and review of standard operating procedures.
- Establish and maintain relationships with orthopedic last mile operations and Franchise customers to solve problems and meet changing competitive and regulatory environments.
- Be a change agent.
- Execute and improve systems/processes in the following areas: Inspection readiness, Process changes, Validation, Calibration and Preventive Maintenance systems, as applicable, Delivery service issues.
- Nonconformance investigation and corrective action plan development, implementation and effectiveness monitoring.
- Coaching and mentoring other functional areas in the areas of ISO and cGMP requirements as needed.
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 period10 days
- Volunteer Leave – 32 hours per calendar year
- Military Spouse Time-Off – 80 hours per calendar year
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What This Job Offers
Job Type
Full-time
Career Level
Senior
