Manager, Quality Systems - Tuscon, AZ | Biospace
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Manager, Quality Systems

HTG Molecular Diagnostics

Location:
Tuscon, AZ
Posted Date:
7/27/2017
Position Type:
Full time
Job Code:
Salary:
Required Education:
Bachelors Degree
Areas of Expertise Desired:
Manager, Quality,

Job Description


Headquartered in Tucson, Arizona, HTG’s mission is to empower precision medicine at the local level. In 2013, the company commercialized its HTG Edge instrument platform and a portfolio of RNA assays that leverage HTG’s proprietary nuclease protection chemistry. HTG’s product offerings have since expanded to include its HTG EdgeSeq product line, which automates sample and targeted library preparation for next-generation sequencing. Additional information is available at www.htgmolecular.com.

HTG is committed to bringing the highest level of simplicity and automation to molecular diagnostics by leveraging proprietary nuclease protection assays and coupling it to next generation sequencing. Our pipeline includes gene expression and mutation based assays in low multiplex using a microarray format and in high multiplex as a front end to Next Gen Sequencing.

Job Location: Tucson, Arizona

Essential Duties

•   Responsible for the maintenance and improvement of key Quality systems and processes.  The incumbent will work in a multidisciplinary environment requiring a broad range of experience, analytical, communications and interpersonal skills.
•   Responsible for implementing new programs, applicable regulatory and statutory requirements, and defining quality requirements for production and development activities.
•   Ensures that all Quality requirements and deliverables are met during the design and production/process control processes
•   Interface with Development and Manufacturing Operations to ensure that design transfer of new products is in accordance with approved data.
•   Plays a major role in the maintenance of an ISO 13485:2003 and QSR Compliant Quality Management System, assisting the VP of Regulatory Affairs and Quality Systems in establishing, implementing and maintaining the quality management system in line with HTG’s strategic goals.
•   Works with Manufacturing Operations, Commercial Operations, and Development for establishment and monitoring of Quality System performance metrics against Quality Objectives for Management Review
•   Root cause analysis and implementation of corrective action for Quality System process related concerns.
•   Responsible for leading risk analysis activities associated with new development programs and ongoing risk management for products in production.
•   Assist in the root cause analysis of complaints and/or audit findings and any associated corrective and preventive action(s).
•   Works with R & D and outside testing facilities to ensure that new products meet both domestic and appropriately identified international standards.
•   Conduct audits, including closing out audit findings, creating audits finding reports and approval of proper corrective and preventive actions.
•   Ensure timely resolution of product quality investigations and associated corrective actions.
•   Assist in the preparation of technical files and declarations of conformity to various international directives to support product commercialization.
•   Represent Quality on development project core teams

Immediate Goals and Objectives

•   Lead the effort to obtain PMA registration to the Tucson facility
•   Drive process improvement throughout the entire Quality System
•   Lead the effort to implement electronic records / signatures
•   Lead the implementation of Quality Key Performance Indicators for Management Review

Requirements


Minimum Qualifications

Education:

•   Bachelor’s degree in a life science or engineering discipline required; graduate degree preferred.
•   Command of an appropriate set of mathematical, statistical and scientific problem solving knowledge to bring to bear on issues encountered.

Experience:

•   Minimum of 12 years’ experience in an FDA regulated environment.
•   Minimum of 10 years’ experience with quality responsibility in IVD environment demonstrating advancement with increasing management responsibility; molecular IVD preferred.
•   Experience managing people successfully.
•   ASQ Certified Engineer, Certified Reliability Engineer, certified Biomedical Auditor or Certified Internal Auditor, and strong QA design experience are all desirable.
•   Knowledge of FDA Quality System Regulations and ISO 13485 is required.  European In Vitro Diagnostic Regulation (IVDR, formally IVDD) knowledge and experience is desirable.