Quality Manager in Indianapolis

MiraVista Diagnostics is actively seeking a Quality Manager in Indianapolis with prior experience in medical device or pharmaceutical environments. The primary responsibility for this position is supporting a new quality management system (QMS) with a scope that provides for the launch of new in vitro diagnostic products.  The Quality Manager (Quality Assurance Manager) will lead and execute projects ranging from quality procedure development to process characterization and implementation of process improvements.

If you’re interested in joining the MiraVista team, please apply for this position using the form on our online Career Center:  http://www.miravistalabs.com/quality-manager-indianapolis/ or email your resume to pbenrubi@miravistalabs.com.

Job Description for Quality Manager

The Quality Manager (Quality Assurance Manager) position requires an individual with extensive knowledge in quality systems and methodologies that can implement and maintain an FDA regulated QMS that complies with ISO 13485 as well as CMS/CLIA standards.  This individual will be responsible for quality assurance activities for the IVD kit production process and associated upstream inputs. Responsibilities for the Quality Manager include:

  • Lead efforts to maintain the QMS compliance and mechanisms for system improvements as the product profile increases in number and international involvement
  • Maintain the QMS supporting the ISO 13485 certification
  • Ensure the site’s process procedures, flow diagrams, FMEAs, and control plans are developed and maintained in accordance to site procedures and governing regulations
  • Maintain metrics and methods for monitoring the effectiveness of the quality system to support compliance and add value
  • Utilize QA methodologies to standardize processes and to link product characteristics, process influences, and control strategies
  • Assess complaint, audit, and process data to determine corrective or preventive actions
  • Provide guidance on equipment, process, software, and test method validation requirements and design control activities for product and process development projects
  • Oversee Quality Management Review, internal audits, and material review meetings
  • Manage and facilitate audits (internal, supplier, 3rd party, CMO)
  • Manage the quality staff and budget as well as ensure individual development activities for self and direct reports that will provide upward or lateral mobility

Qualifications for the Quality Manager

  • 8-12 years of experience in a cGMP facility preferred
  • Prior IVD experience is highly desirable
  • Proven ability to facilitate commercialization of FDA regulated product
  • Minimum of 8 years in medical device or pharmaceuticals with at least 5 years working with production processes and quality systems
  • Bachelor’s degree in a science or engineering discipline. Other educational experience will be considered in conjunction with work experience
  • Proven understanding of external regulations, particularly with regards to 21 CFR Part 820 and ISO 13485
  • Strong oral and written communication skills and adept at establishing interpersonal relationships
  • Proven ability to work in a team environment, balancing compliance risk with business need.
  • Open minded and collaborative
  • Detail oriented
  • Exposure to international regulations and incorporation into the QMS

 

 

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