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Associate Director of Quality Assurance - Manufacturing QA Systems

Location: Salt Lake City, UT, United States
Position Type: All
Job Function: Quality

Description

At BioFire Diagnostics, LLC. we make the world a healthier place by providing molecular solutions that lessen the time to medical results and empower healthcare professionals to make better diagnostic decisions. At BioFire Diagnostics, LLC. we make the world a healthier place by providing molecular solutions that lessen the time to medical results and empower healthcare professionals to make better diagnostic decisions. 

We are proud to be part of the bioMérieux family and the 5,000+ team members across 12 sites and subsidiaries in North America committed to our mission to help save lives around the globe through the power of diagnostics. 

Come be a part of our team and our mission as an Associate Director of Quality Assurance - Manufacturing QA Systems!

Position Summary

Responsible for the day to day management of specific processes and personnel related to the BioFire Diagnostics (BFDX) Quality Assurance Systems.

Specific responsibilities include management of the managers and team members in the Manufacturing QA Systems, which include CAPA, Management Review, Audits, and QMS Projects.

In addition to managing these processes and people, the Associate Director may perform Internal and Supplier Audits with the goal of ensuring that the audit program stays on schedule and is External Audit ready.  The position will also include day to day activities involving review/approval of Change Orders, complaints, NCRs and CAPAs related to Audit findings.  Responsible for overall maintenance of Quality system and generation of Quality System reports.

Responsible for identifying and analyzing trends in productivity, quality, and customer service.  Reports QMS metrics and issues to Senior QA managers and Executive Management.  Relies on extensive experience and judgment to plan and accomplish goals. Leads and directs the work of others. A wide degree of creativity and latitude is expected. 

 

Principle Job Duties and Responsibilities

Perform all work in compliance with company policy and within the guidelines of BFDX’s Quality System.

Generic supervisory duties, including:  Delegate duties and assure understanding of same; measure and appraise performance against job duties, objectives and projects; assist in skills/career development; provide motivating work environment and accurate feedback on performance; recommend/approve merit increases, promotions, hires and terminations. Review and approval of timekeeping records and paid time off (PTO).

Assist with the development and implementation of new Quality System processes and policies.

Maintain Quality System data and prepare reports working with the Quality Director and other key stakeholders in the prompt resolution of significant quality issues.

Oversee general training including GMP and ISO requirements

Assist internal auditors with preparation of audit plans and review of findings

Review of external audit findings with relevant cross-functional teams; aid in determining corrections, corrective actions, and root cause investigations.

Develop and maintain department budget

Participate in external audits (eg. FDA, Notified Body)

CAPA System

Oversee company CAPA system to ensure ongoing compliance to QMS requirements

Monitor CAPA program, including tools and administration of the process

QMS Projects

Lead a team of Project Manager(s) and Project Coordinator(s) to implement QMS improvement projects

Management Review

Manage Quality Analyst to develop and report relevant QMS KPI’s to senior level and executive management.

Audits

Manage Internal, External, and Supplier Audit Readiness program to ensure continued QMS compliance to regulatory requirements.

Manage communication between Notified Body and manufacturer

Manage external audit related logistics

 

Principle Decisions

  1. Compliance of routine activities with company policy and procedures and regulatory requirements, including: release of product to stock from Quarantine or Stop/Ship; approval of documentation changes (Change Orders) with assurance that all appropriate functions have reviewed and approved the change; failure investigations are thorough and reviewed by appropriate expertise.
  2. Referral of non-routine and complex issues to higher authority and/or functional experts.
  3. Determination of out-of-compliance product and situations, including appropriate notification and follow-up

 

Supplemental Data

Knowledge of a broad range of biological, chemical, Engineering, tooling, and statistical principles, methods and practices is required to facilitate appropriate decision making and recognition when additional expertise is needed to solve problems.

Position requires an in-depth knowledge of regulatory requirements for manufacturers of medical devices and applicable contractual requirements affecting BioFire’s Quality System.

 

Travel Requirements:

Position will require between 5-10% domestic travel targeted towards attending relevant Quality and Regulatory trainings. Minimal international travel may be required for attending relevant conferences or trainings.

Position may require between 20-30% domestic and international travel to perform supplier QMS audits.

Position may require between 5-10% domestic and/or international travel to meet with tooling/measurement system manufacturer.

 

Qualifications

Training and Education

Requires a BS degree (science or engineering major).  Appropriate college level classes and/or extensive experience in QA field for the Engineering and/or Medical Device industry can substitute for a degree.

Certification in Quality Management Systems for FDA – CFR, ISO 13485, and ISO 9001 preferred. Upon hire, candidate will be required to complete certification courses for listed standards

Lead Auditor or Biomedical Auditor Certification preferred. Upon hire, candidate will be required to complete certification courses for auditing.

Minimum 2 years of Project Management experience

Minimum 1 year of auditing experience for Medical Device or In Vitro Diagnostic manufacturer

 

Experience

Minimum 5 years of experience in device or pharmaceutical or biotechnology QA.

Minimum 3 years’ work experience in Quality Management Systems for FDA – 21 CFR 820, ISO 13485, and ISO 9001

MDSAP experience a plus, but not required

Knowledge of In Vitro Diagnostic Regulation a plus, but not required

Minimum 3 years’ direct management of individuals/teams

 

Skills

Knowledge of quality principles applicable to in vitro diagnostic products, including FDA QSR (eg. 21 CFR 820), ISO 13485

Ability to quickly differentiate between issues that can be resolved at this level and those that should be referred to the Director of QA/RC or higher authority.

Investigative skills required to perform trend analyses and failure investigations.

Tactical management and people skills are required and applied in the supervision of employees and negotiation with BioFire employees in other departments.

Demonstrate high proficiency in following MS Office applications: Word, Excel, and PowerPoint

Demonstrate basic proficiency in following MS Office applications: Outlook, Visio

 

Physical Requirements

Must be able to sit or stand for moderate amounts of time and look at computer monitors for an extended amount of time with or without accommodation.

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