Senior Quality and Compliance Specialist

Job not on LinkedIn

🔥 12 minutes ago

🔔 Pennsylvania – Remote

🔔 Pennsylvania – Remote

💵 $94k - $151.8k / year

⏰ Full Time

🟠 Senior

🚔 Compliance

🦅 H1B Visa Sponsor

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Johnson & Johnson

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1886

🏥 Healthcare

⚕️ Healthcare Insurance

💊 Pharmaceuticals

Healthcare • Healthcare Insurance • Pharmaceuticals

Johnson & Johnson is a multinational corporation focused on innovating across multiple sectors of healthcare and medicine. With a commitment to redefining healthcare, the company merges science and technology to address complex diseases through its divisions in innovative medicine and medical technology. Its areas of focus include oncology, immunology, neuroscience, and specialty ophthalmology, as well as interventional solutions and orthopaedics. J&J is dedicated to advancing global health equity and environmental sustainability while fostering innovation, diversity, and inclusion in the workplace. The company strives to provide solutions that connect health and care for providers, patients, and communities worldwide.

📋 Description

• Develop, execute, and oversee Quality and Compliance programs for the orthopedic last mile operations network within the United States • Support internal and external orthopedic last mile Field Inventory operations, Loaner Sites, and Distribution Centers delivering field inventory and surgical loaner sets • Collaborate with Quality, Supply Chain, Delivery, Sales, and Commercial partners on distribution and commercial quality matters • Drive timely resolution of quality-related issues and support improvement opportunities aligned with business objectives and regulations • Define, implement, and validate quality requirements and systems • Serve as the 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 • Develop, implement, and review standard operating procedures • Maintain relationships with orthopedic last mile operations and Franchise customers • Execute and improve inspection readiness, process changes, validation, calibration, preventive maintenance, and delivery service issue systems/processes • Investigate nonconformances and develop, implement, and monitor corrective action plans for effectiveness • Coach and mentor other functional areas on ISO and cGMP requirements

🎯 Requirements

• A minimum of a Bachelor’s 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 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 assigned work accurately and on time, maintain organized records, and escalate issues when needed • Apply critical thinking, problem-solving, and root cause analysis • Working knowledge of quality system requirements, good documentation practices, technical writing, Nonconformance, and CAPA • Proficiency with Microsoft Office, data analysis, and quality system applications • Preferred experience with Windchill, ETQ, Summit, ERP, or warehouse management systems • Preferred experience with audit preparation, inspection readiness, regulatory responses, or health authority interactions • Preferred certifications or training in Lean, Six Sigma, 5S, ASQ, ISO-13485, Good Distribution Practices, supplier quality, or other quality improvement methods

🏖️ 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 residing in Colorado; 56 hours for employees residing 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 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 • Inclusive interview process and disability accommodations • Up to 25% domestic and international travel may be required