Quality Assurance Supervisor

Lab Pros, Inc.

Quality Assurance

August 15, 2014

The Quality Assurance Supervisor is responsible for managing an operational Quality System to include all programs, procedures and processes which ensure organizational compliance with regulatory requirements. The position will execute the quality system in a team based environment with Manufacturing, Packaging, Materials, Engineering, and Research & Development to ensure all quality, production, and development goals are met.

Specific Responsibilities

  • Maintain company compliance with Quality System regulations in accordance to 21 CFR 820, ISO 13485, CMDR and MDD requirements by evaluating current procedures and practices  
  • Coordinate closely with Manufacturing, Quality Control, Engineering and Facilities to meet customer requirements
  • Oversee and participate in batch record review and coordination of intermediate and finished product releases
  • Responsible for the hiring, training, development and evaluation of QA personnel
  • Manage the Supplier Audit Program; implement systems to measure and track supplier quality
  • Conduct periodic internal audits and oversees internal audit program, recommend corrective action and work with appropriate department to implement required corrective action
  • Active participant in audits performed by customers and regulatory agencies
  • Responsible for Document Control processes, procedures and storage
  • Manage the internal training program to include documentation and evaluation of training effectiveness
  • Prepare and deliver periodic reporting on quality performance in accordance with company policy and external regulatory requirements
  • Perform statistical analysis to analyze trends and improve process control
  • Perform GAP analyses of in-house practices versus relevant regulations, standards and industry practices
  • Participate in project teams as assigned

Requirements:

  • Bachelors Degree in the life sciences or related engineering field A minimum of 10 years experience within Quality Assurance with a demonstrated knowledge of cGMP/QSR
  • Experience working in a high volume commercial manufacturing operation is preferred
  • Demonstrated knowledge of regulatory requirements under FDA, ISO 13485:2003, MDD is required
  • A minimum of 3 years of supervisory experience 
  • Excellent verbal and written communication skills
  • Project Management experience is preferred

 

 

 

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