Director of Quality Assurance and Regulatory Affairs Jobs in Lynnwood, WA
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.
- Bothell, WA (5 miles from Lynnwood, WA)
- 24 days ago
- Bothell, WA (5 miles from Lynnwood, WA)
- 24 days ago
Director, Regulatory Affairs Location US-WA-Bothell ID 2025-1489 Category Quality Assurance/Regulatory Affairs Position Type Full Time Work Model Onsite Company Overview Verathon is a global...
Chemistry/Physics Lab Manager - Instruction And Classroom Support Technician 4
- Lynnwood, WA
- 45+ days ago
- Lynnwood, WA
- 45+ days ago
Edmonds College is committed to diversity, equity and inclusion. The college values its talented, diverse workforce and seeks to attract, hire, and support employees who consistently and actively...
Chemistry/Physics Lab Manager - Instruction & Classroom Support Technician 4 (C)
- Lynnwood, WA
- 45+ days ago
- Lynnwood, WA
- 45+ days ago
Position Overview Edmonds College is committed to diversity, equity and inclusion. The college values its talented, diverse workforce and seeks to attract, hire, and support employees who...
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Director of Quality Assurance and Regulatory Affairss in Lynnwood, WA 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
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- GxP
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- Institutional Review Board
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- Medical Device Sales
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- FDA Regulations
- Corrective Actions & Preventive Actions
- Good Manufacturing Practices
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- Diagnostic
- Masters In Education
- Engineering
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- Written Communication
- Quality Assurance
- Collaboration
- Documentation
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- Research Skills
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