Director of Quality Assurance and Regulatory Affairs Jobs in Milpitas, CA
A Director of Quality Assurance and Regulatory Affairs in the biotechnology industry is essentially responsible for developing and implementing systems that ensure products meet quality standards and regulatory requirements. This includes conducting internal audits, leading investigations into quality issues, liaising with regulatory bodies, and overseeing the submission of regulatory documents. They are also responsible for ensuring compliance with regulatory requirements and standards such as ISO, FDA, and EMEA. They play a crucial role in maintaining the company's reputation and ensuring customer satisfaction by ensuring that products are safe, reliable, and meet both customer and regulatory requirements.
Key skills for this role include strong analytical and problem-solving skills, excellent communication skills, and a strong knowledge of the biotechnology industry and its associated regulations. They should also have strong leadership skills, as they will often be leading teams and coordinating with other departments. Important certifications may include Certified Quality Auditor (CQA), Certified Quality Engineer (CQE), Regulatory Affairs Certification (RAC), or Certified Quality Manager (CQM). Prior to becoming a Director of Quality Assurance and Regulatory Affairs, an individual may have roles such as Quality Assurance Manager, Regulatory Affairs Specialist, or Senior Quality Engineer within the industry.
Summary Responsible for quality of assigned BD Biosciences (BDB) New Product Development (NPD) medical devices products to ensure business objectives are met with regards to on time delivery of...
- Palo Alto, CA (18 miles from Milpitas, CA)
- 16 days ago
- Palo Alto, CA (18 miles from Milpitas, CA)
- 16 days ago
Lab Manager Ford Motor Company - 4.1 Palo Alto, CA Job Details Estimated: $79.8K - $108K a year 23 hours ago Benefits Paid parental leave Paid holidays Visa sponsorship Health insurance Dental...
- Palo Alto, CA (19 miles from Milpitas, CA)
- 19 days ago
- Palo Alto, CA (19 miles from Milpitas, CA)
- 19 days ago
We are the movers of the world and the makers of the future. We get up every day, roll up our sleeves and build a better world -- together. At Ford, were all a part of something bigger than...
Director, Regulatory Affairs - Job ID: DRA
- Palo Alto, CA (18 miles from Milpitas, CA)
- 22 days ago
- Palo Alto, CA (18 miles from Milpitas, CA)
- 22 days ago
Director, Regulatory Affairs - Job ID: DRA Ascendis Pharma - 4.8 Palo Alto, CA Job Details Full-time $225,000 - $240,000 a year 15 hours ago Benefits Paid parental leave Health savings account...
- Santa Clara, CA (8 miles from Milpitas, CA)
- 30+ days ago
- Santa Clara, CA (8 miles from Milpitas, CA)
- 30+ days ago
NVIDIA Silicon Solutions Group is seeking an engineering Lab Manager to join our team! In this role, you will manage hardware engineering labs, being responsible for all lab operations to support...
Research Coordinator & Lab Manager @ 50% FTE (Remote Opportunity)
- Stanford, CA (19 miles from Milpitas, CA)
- 45+ days ago
- Stanford, CA (19 miles from Milpitas, CA)
- 45+ days ago
Stanford University is seeking a Research Coordinator & Lab Manager working remotely and required to go on-site 1 day or less per week. This position will perform duties related to data quality...
Regulatory Affairs Manager Vascular (on-site)
- Santa Clara, CA (8 miles from Milpitas, CA)
- 60+ days ago
- Santa Clara, CA (8 miles from Milpitas, CA)
- 60+ days ago
Preferred Qualifications Bachelor's degree in science (biology, chemistry, microbiology, immunology, medical technology, pharmacy, pharmacology), math, engineering, or medical fields....
- Stanford, CA (19 miles from Milpitas, CA)
- 90+ days ago
- Stanford, CA (19 miles from Milpitas, CA)
- 90+ days ago
At least one year of research experience in molecular biology and cell culture, and proficiency in animal necropsy, tissue dissociation, flow cytometry, immunocytochemistry, tissue cryo-sectioning and...
Director / Senior Director, Regulatory Affairs
- Redwood City, CA (23 miles from Milpitas, CA)
- 90+ days ago
- Redwood City, CA (23 miles from Milpitas, CA)
- 90+ days ago
About Soleno Therapeutics Inc Soleno Therapeutics, Inc., based in Redwood City, California, is a clinical-stage biopharmaceutical company developing novel therapeutics for the treatment of rare...
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Director of Quality Assurance and Regulatory Affairss in Milpitas, CA offer the following education backgroundQualifications / Skill Sets
The following top skills are often required or desired to land a Director of Quality Assurance and Regulatory Affairs position
- Mentoring
- Electrical Engineering
- Affirmative Action
- Quality Systems
- ISO Certified
- Implementation
- Hazardous Materials
- Quality Management
- Document Control
- Coaching
- Inspections
- ISO 13485
- Quality Management Systems
- Control Systems
- Batch Record Review
- GxP
- TrackWise
- Institutional Review Board
- Spectrophotometer
- Gene Therapy
- ICH Guidelines
- Lab Safety
- Molecular Biology
- Genotyping
- Drug Development
- Biology
- Biochemistry
- Microbiology
- Biotechnology
- Good Laboratory Practice
- Laboratory Management
- Medical Device Sales
- Equipment Calibration
- FDA Regulations
- Corrective Actions & Preventive Actions
- Good Manufacturing Practices
- Research and Development
- Process Development
- Diagnostic
- Masters In Education
- Engineering
- Strategy Development
- Auditing
- Written Communication
- Quality Assurance
- Collaboration
- Documentation
- Inventory Management
- Regulations
- Project Management
- Problem Solving
- Research Skills
- Staff Supervision
- Organization
- Scheduling
- Leadership
- Communication Skills
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