Associate Director, Quality Engineering

Position Summary:

Responsible for the day-to-day management of specific processes and personnel related to the bioMerieux Quality Assurance System. Specific responsibilities include management of the Quality Engineering managers and team members for Manufacturing QA Reagents.

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, validations, NCRs and CAPAs related to Audit findings.  Responsible for overall maintenance of the 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 Top 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.  

Primary Duties:

·       Perform all work in compliance with company policy and within the guidelines of its 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) 

Other Duties:

·       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.

·       Referral of non-routine and complex issues to higher authority and/or functional experts.

·       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 bioMerieux’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.

Qualifications:

Training and Education

·       Requires a BS degree (science or engineering major).   

·       Certification in Quality Management Systems for FDA – CFR, ISO 13485, and ISO 9001 preferred.

Experience

·       Minimum 8 years of Engineering, Scientific or Investigative experience in a regulated industry.

·       Minimum 5 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

Knowledge, Skill, and Abilities

·       Knowledge of quality principles applicable to in vitro diagnostic products, including FDA QSR (e.g. 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.