We are looking for a Quality Assurance Specialist to join our team and oversee the quality of all products and services that our organization produces. Quality Assurance Specialist responsibilities include developing quality standards, conducting tests and identifying issues in the production of our products or services.
Job Description
Write and review of SOPs and other quality assiuance related technical data forms and quality documents
proper maintenance of control documents in Quality Assurance
Control documents to differents departments
Review validation protocols for GMP compliance
Assist in carrying out internal quality audits on company systems and documentations
perform investigations on non-conformances and customer complaint close out and corrective actions
Audit on-going vendors, systems and documents to assure quality assurance compliance with regard to all internal procedures as well as regulatory guidelines
Provide GCP/ QA support and avdvice to internal and external clients
Ensure the timely and effective follow up to all identified or assigned quality issues
Maintains and demonstrates understanding of global standards, regulation and regulatory bodies to include but not limited to ISO13485, 21FR; part 820 AIMD
Assist in the maintenance ogf Quality Management System under direction of Director, Quality Assurance
Participate in Mock inspections for FDA inspection preparation
Preferred Qualifications
- Strong organizational, problem-solving, and analytical skills
- Ability to manage multiple tasks at once
- Proven leadership ability
- Strong interpersonal skills
- Good judgment and ability to make decisions in a timely manner
- Strong regard for quality assurance according to company standards
- Good knowledge about industry products and processes
- Basic mathematical arithmetic
- Excellent oral and communication skills
- Excellent presentation and reporting skills
- Good team player who can work efficiently with minimal supervision