Associate Director – Quality Assurance

🔥 0 minutes ago

🏖️ New Jersey, Pennsylvania – Remote

🏖️ New Jersey – Remote 🔔 Pennsylvania – Remote

💵 $142.4k - $224.1k / year

⏰ Full Time

🟠 Senior

🔧 QA Engineer (Quality Assurance)

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MSD

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1891

🧬 Biotechnology

💊 Pharmaceuticals

⚕️ Healthcare Insurance

Biotechnology • Pharmaceuticals • Healthcare Insurance

MSD is a leading biopharmaceutical company known as Merck & Co. , Inc. in the United States, Canada, and Puerto Rico, and as MSD globally. The company focuses on scientific innovation to deliver medicines and vaccines for various health challenges, including oncology, vaccines, infectious diseases, and cardio-metabolic diseases. MSD operates multiple divisions, including Human Health, Animal Health, and Research & Development. With approximately 75,000 employees worldwide and a significant investment in research and development, MSD is committed to improving global health through its scientific advancements. Additionally, the company places a strong emphasis on diversity, inclusion, and corporate responsibility. MSD’s operations extend worldwide, offering opportunities in numerous regions and promoting diversity and innovation in all aspects of its business.

📋 Description

• Reporting to the Senior Director of Device Quality and Regulatory (DQ&R), the Associate Director Quality Engineering & Quality Assurance is responsible for independent compliance support of Medical Devices including the device constituent part of Combination Products. • Interact with cross functional teams working with all levels of employees. • Develop, document, and maintain technical business solutions, reviewing and approving medical device/combination product documentation to support regulatory filings and audits of data, policies, procedures, and systems to ensure compliance with Medical Device (21CFR 820s) and Combination Product current Good Manufacturing ruling (21CFR part 4), Device Risk Management (ISO 14971) and other worldwide regulations and company requirements. • Provide Device quality engineering and quality assurance support and leadership to ensure successful quality oversight of prospective medical devices and medical device combination products.

🎯 Requirements

• 7 years of relevant work experience • Extensive knowledge of applicable medical device regulations (21CFR820, 21CFR Part 4, EU MDR, ISO 13485) • Experience with Design Controls / CAPA / Purchasing Controls as it related to 21CFR820 • Risk Management experience (ISO 14971/24971, ICH Q9) • Effective communication skills and working knowledge of device development and commercialization, product approval, and/or regulatory inspection experience with medical devices. • A Bachelor’s degree in (Science or Engineering or associated fields) with a minimum of 7 years related experience OR a Master’s degree (Science or Engineering or associated fields) and 5 years related experience or a Ph.D. (Science or Engineering or associated fields) and 3 years of related experience

🏖️ Benefits

• medical, dental, vision healthcare and other insurance benefits (for employee and family) • retirement benefits, including 401(k) • paid holidays • vacation • compassionate and sick days