QA MANAGER- Healthcare

Company Description

Small company, the Quality team is made up of the manager and one associate, we need someone very good with rolling up their sleeves.

Job Description

The successful candidate will be responsible for maintaining the quality systems strategy and providing coordination and direction of existing quality programs to ensure production of products, services, and processes are consistent with established standards.

Essential Duties: 
• Developing and overseeing execution of companies audit plans/strategies. 
• Process and evaluate audit findings to monitor overall compliance and to identify quality related trends/issues, areas of business and/or regulatory risk, and training needs 
• Provide consultation on regulatory compliance issues 
• Ensure performance and quality of products and services conform to established company and regulatory standards. 
• Host external regulatory agency and notified body assessments and inspections (example: FDA, ISO). Review and participate in issues and/or decisions related to assessments. 
• Serve as the site management representative, providing updates to the company and the VP of Bioservices regarding status of the quality system, compliance status and performance relating to quality. 
• Maintain the biological and chemical waste management programs to ensure compliance to Local, State and DOT regulations. 
• Act as a customer interface during on-site audits, conference calls and other standard means of communication.

Qualifications

MUST HAVES:  
• BS in Physical, Biological Sciences, or technical/scientific discipline required 
• Experience with ISO 9001/13485 
• Experience with validation 
• Experience guiding or managing the CAPA and NCR process 
• Experience in a pharmaceutical or life sciences organization 
• Experience leading FDA/ISO audits 
• Experience in GMP environment 
• CLIA experience helpful
• 5-8 years (8 years maximum) experience as a Quality Professional in a regulated medical device, in vitro diagnostics, or life science industry. 
• 5 years previous supervisory experience, preferably in Quality Systems or Quality Assurance. 
• American Society for Quality certification desirable. 
• In-depth knowledge and application of regulations, guidelines and industry practices and the ability to interpret the regulations/guidelines 
• Ability to effectively present information to management, regulatory agencies and other departments. 
• Experience interpreting and complying with cGMP, CLIA, IVDD or MDD, working 
• Excellent interpersonal, communication, analytical, managerial, and organizational skills. 
• Strong attention to detail in composing and proofing materials, establishing priorities, scheduling and meeting deadlines.

Additional Information