Tampa, Florida
Associate Manager of Quality Systems and Regulatory Affairs Job Opening in Tampa, Florida - Sri Trang USA is a global leader in the manufacture and supply of natural rubber and a broad range of hand protection products sold to healthcare providers in hospitals, clinics and many other professional settings. Exciting expansion is underway in the development of other product line offerings in the infection prevention category to strengthen our market share and the value we bring to clinicians and healthcare staff across the U.S.
Associate Manager of Quality Systems and Regulatory Affairs
Manages quality assurance programs and inspection of product lines. Reviews and interprets established policies and procedures and formulates recommendations for revisions as necessary. Position requires advanced decision making experience and skills.
ESSENTIAL FUNCTIONS AND RESPONSIBILITIES
Evaluate systems, analyze data, evaluate products and establish control procedures
Inspect and audit products and provide reports and recommendations for improvements, change as deemed appropriate
Interpret, manage, and maintain CGSB, Food and Drug Administration (FDA), 510(k) submissions, US Customs matters, including product detentions, and the C-TPAT program
Develop and manage standard operation procedures (SOP)
Communicate and establish rapport with outside agencies
Assist in the evaluation process of potential vendors
Review, process, and monitor complaints
JOB
Bachelor?s degree in life sciences, engineering or related field
At least 3 years of quality assurance experience in the medical device industry
Experience working with the FDA, American Society for Testing and Materials (ASTM), 510(k) submissions, and 483s
Must have experience developing and maintaining SOPs
Ability to identify and assess business risks and develop a regulatory strategy
Ability to build relationships with other areas of the business, outside clients, and regulatory agencies
Proficient with Microsoft Suite including Excel, PowerPoint, Word, and Outlook
Must be detail oriented
Must have a valid passport and ability to travel overseas quarterly
Sri Trang USA offers fantastic benefits including 100% employer paid medical, dental, life insurance, LTD, STD, 401k with employer matching and employer-funded flexible spending account.
Job Type: Full-time
Required education:
Bachelor's
Required experience:
Quality Assurance: 3 years
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