Associate Director – Quality Assurance

🕒 June 25

🏖️ New Jersey, Pennsylvania – Remote

🏖️ New Jersey – Remote 🔔 Pennsylvania – Remote

💵 $142.4k - $224.1k / year

⏰ Full Time

🟠 Senior

🔧 QA Engineer (Quality Assurance)

🦅 H1B Visa Sponsor

This company has sponsored H1B visas in the past.

👻 Ghost score 55%

What it means: how likely this posting is sitting open without active hiring.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

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MSD

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1891

🏥 Healthcare

📦 Logistics

🧬 Biotechnology

Healthcare • Logistics • Biotechnology

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

• Represent the DQ&R Quality function on commercial and product/core development teams • Review and approve Design Control and Device Risk Management documentation for regulatory filings, clinical supply, development, design transfer qualification, and post-marketing surveillance • Evaluate deficiencies and assess their impact on compliance status • Develop and revise policies and procedures for DQ&R Quality and supported areas • Monitor industry trends, worldwide regulations, and industry standards • Guide Manufacturing and Research and Development device functions in implementing end-to-end Design Control principles • Participate in design reviews, CAPA reviews, and technical reviews of combination products • Oversee purchasing controls and supplier quality throughout combination product development • Work with external partners to develop products • Review and approve verification and validation test protocols and reports • Provide input to material specifications, drawings, inspection procedures, and manufacturing procedures • Translate customer needs into critical-to-quality and design input/output requirements • Lead and manage Design and Development File deliverables for medical devices • Provide independent compliance support and quality oversight for medical devices and combination products • Develop, document, and maintain technical business solutions • Review and approve medical device and combination product documentation supporting regulatory filings and audits

🎯 Requirements

• 7 years of relevant work experience • Extensive knowledge of medical device regulations, including 21 CFR 820, 21 CFR Part 4, EU MDR, and ISO 13485 • Experience with Design Controls, CAPA, and Purchasing Controls related to 21 CFR 820 • Risk Management experience with ISO 14971/24971 and ICH Q9 • Working knowledge of device development and commercialization, product approval, and/or regulatory inspection experience with medical devices • Ability to work independently within a cross-functional framework • Detailed technical writing and review skills • Ability to work in a matrix organization • Effective written and oral communication skills • Bachelor’s degree in Science, Engineering, or associated fields with 7 years related experience, or Master’s degree with 5 years related experience, or Ph.D. with 3 years related experience • Remediation experience desired • Knowledge of current GMPs for combination products • Lean Six Sigma Green Belt or Black Belt or ASQ certifications preferred • Understanding of GMP, Good Documentation Practices, and project management principles desirable • Lean Six Sigma principles and tools, including DOEs, root cause analysis, and problem-solving methods desired • Experience using root cause analysis and applied statistical techniques • US-based work location; NJ/PA or another US location • Willingness to travel approximately 10% of the time • No visa sponsorship • Valid driving license not required

🏖️ Benefits

• Annual bonus and long-term incentive, if applicable • Medical, dental, and vision healthcare • Other insurance benefits for employee and family • Retirement benefits, including 401(k) • Paid holidays • Vacation • Compassionate days • Sick days • Remote work arrangement