Commercial Quality Compliance Specialist

Job not on LinkedIn

🔥 0 minutes ago

🍂 Massachusetts, Pennsylvania – Remote

🍂 Massachusetts – Remote 🔔 Pennsylvania – Remote

💵 $79k - $127.7k / year

⏰ Full Time

🟢 Junior

🟡 Mid-level

🚔 Compliance

🦅 H1B Visa Sponsor

This company has sponsored H1B visas in the past.

👻 Ghost score 0%

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Johnson & Johnson

WebsiteLinkedInAll Job Openings

10,000+ employees

🏥 Healthcare

💊 Pharmaceuticals

🧬 Biotechnology

Healthcare • Pharmaceuticals • Biotechnology

<Johnson & Johnson> is a global healthcare company that researches, develops, manufactures and markets pharmaceuticals, medical devices and consumer health products. The company focuses on innovative medicines and therapies across oncology, immunology, neuroscience and cardiopulmonary areas, and develops MedTech solutions in cardiovascular, orthopaedics, surgery and vision. Johnson & Johnson also engages in health & wellness education, large-scale manufacturing, investor activities and global social-impact initiatives.

📋 Description

• Develop, execute, and oversee Quality and Compliance programs for DePuy Synthes Sales Inc. • Support Distribution Centers, Loaner Distribution Points, and Field Inventory Managers in the United States • Focus on “last mile” delivery of surgical loaner sets supporting orthopedic customers across the US • Serve as liaison with Franchise Quality, Sales, Commercial Operations, and Supply Chain partners • Drive timely resolution of commercial and distribution quality-related issues • Identify and support implementation of fit-for-purpose quality and compliance improvements • Align improvements with business objectives, Quality Standards, applicable regulations, and customer experience

🎯 Requirements

• Bachelor Degree in regulatory compliance, science, or engineering with at least 2 years of experience in a regulated healthcare industry, OR Associate degree with minimum of 5 years of experience in a regulated healthcare industry • Knowledge of applicable FDA regulations and ISO-13485 standards • Self-directed, with flexibility to work independently and on teams • Ability to collaborate and communicate concepts in an easily understood way • Proven time and project management skills • Strong problem solving, root cause analysis, and analytical experience • Proven experience in a regulated healthcare industry • Experience in a fast-paced, complex operation • Supplier quality management experience preferred • Experience interacting with Health Authority or notified body preferred • Supplier Quality experience preferred

🏖️ Benefits

• Consolidated retirement plan (pension) • Savings plan (401(k)) • Long-term incentive program • Vacation – 120 hours per calendar year • Sick time – 40 hours per calendar year; 48 hours for Colorado employees; 56 hours for Washington employees • 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