Senior Quality & Compliance Specialist

This is a fully remote position, open to applicants in Pennsylvania.

📋 Description

• Develop, implement, and manage Quality and Compliance programs for the orthopedic last-mile operations network across the United States.

• Assist both internal and external orthopedic last-mile Field Inventory operations, Loaner Sites, and Distribution Centers.

• Work in partnership with Quality, Supply Chain, Delivery, Sales, and Commercial teams on distribution and commercial quality issues.

• Facilitate prompt resolution of quality-related challenges and support the execution of improvement initiatives.

• Establish, implement, and verify quality requirements and systems.

• Act as the primary point of contact for designated operations.

• Organize and conduct audits, inspections, investigations, and remediation efforts.

• Ensure the Quality program adheres to regulatory compliance standards.

• Provide quality assistance for both existing and new distribution processes and go-to-market strategies.

• Create, implement, and assess standard operating procedures.

• Build and maintain relationships with orthopedic last-mile operations and Franchise clients.

• Implement and enhance inspection readiness, process modifications, validation, calibration, preventive maintenance, and delivery service issue protocols.

• Explore nonconformances and create, execute, and monitor corrective action plans for effectiveness.

• Mentor and coach functional areas on ISO and cGMP standards.

⛳️ Requirements

• A minimum of a Bachelor's degree or equivalent University qualification is essential.

• 6–7 years of pertinent work experience in regulated healthcare, medical device, pharmaceutical, consumer products, distribution, commercial quality, or quality systems sectors.

• Familiarity with FDA regulations CFR 820, ISO 13485, ISO 9001, and quality system requirements applicable to medical devices, commercial distribution, and field inventory settings.

• Experience in supporting quality systems, document control, training compliance, quality metrics, audits, nonconformance management, corrective action processes, or related compliance functions.

• Proficiency in using quality system IT platforms like Windchill, ETQ, DMS, LMS, QEM, Summit, change control systems, ERP systems, warehouse management systems, or similar tools is preferred.

• Capability to communicate and collaborate effectively with cross-functional teams.

• Ability to adhere to established procedures, complete assigned tasks accurately and timely, maintain organized records, and escalate issues when necessary.

• Strong critical thinking, problem-solving, and root cause analysis abilities.

• Working knowledge of standard quality system requirements, good documentation practices, technical writing, nonconformance, and CAPA.

• Proficiency in Microsoft Office, data analysis, and quality system applications.

• Preferred experience with Windchill, ETQ, Summit, ERP, or warehouse management systems.

• Preferred familiarity with audit preparation, inspection readiness, regulatory responses, or interactions with health authorities.

• Preferred certifications or training in Lean, Six Sigma, 5S, ASQ, ISO 13485, Good Distribution Practices, supplier quality, or other quality enhancement methods.

• Willingness to travel domestically and internationally up to 25% of the time.

🏝️ Benefits

• Retirement plan (pension).

• Savings plan (401(k)).

• Vacation – 120 hours per calendar year.

• Sick time – 40 hours per calendar year; 48 hours for employees living in Colorado; 56 hours for employees living in Washington.

• 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.

• Employee benefits outlined at https://www.careers.jnj.com/employee-benefits.