Sr Quality & Compliance Specialist

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Quality

Quality Assurance

Professional

Remote (US), West Chester, Pennsylvania, United States of America

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.

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.

• 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.

• 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.

A minimum of a Bachelors or equivalent University degree is required.

• 6-7years 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.
• 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.

• Communicate and collaborate effectively with cross-functional partners.
• Follow established procedures, complete…