Overview
Associate Director, Quality Assurance – Remote Jobs in Rahway, New Jersey, USA at MSD
Employer
***** Medical Devices and Combination Products
Why consider this job *****
Salary up to $219,700
Bonus eligibility and long-term incentives available
Comprehensive health care and insurance benefits for employees and their families
Retirement benefits, paid holidays, vacation, and sick days
Opportunity for career advancement and growth within a leading organization
Hybrid work model allowing flexibility with remote work options
What to Expect (Job Responsibilities):
Provide compliance support for medical devices and combination products, ensuring adherence to regulatory requirements
Review and approve documentation for regulatory filings, clinical supply, and post-marketing surveillance
Contribute to policy and procedure development for quality assurance in medical devices
Participate in design reviews and provide guidance on Design Control principles
Collaborate with external partners to develop and validate medical device products
What is Required (Qualifications):
Bachelor’s degree in Science, Engineering, or related fields with a minimum of 7 years of relevant experience, or a Master’s degree with 5 years, or a Ph.D. with 3 years of related experience
Extensive knowledge of medical device regulations (21
CFR
820, 21
CFR Part 4, EU MDR, ISO 13485)
Experience with Design Controls and Risk Management processes
Strong communication skills and ability to work independently in a cross-functional environment
Proficiency in technical writing and documentation review
How to Stand Out (Preferred Qualifications):
Experience with remediation in medical device compliance
Knowledge of Good Manufacturing Practices for combination products
Familiarity with Lean Six Sigma principles and tools
Certification as a Lean Six Sigma Green Belt or Black Belt
Experience in applied statistical techniques and root cause analysis
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Title: Associate Director, Quality Assurance – Remote
Company: MSD
Location: Rahway, New Jersey, USA
Category: Healthcare, Quality Assurance – QA/QC
