Quality Management RepresentativeQuality Engineer

Position Summary:

This position leads the Salt Lake City Murray facility efforts to develop implement and continually improve Quality Systems to ensure customer requirements are implemented into company products and services provided. Ensures operational compliance with applicable government regulations (FDAQuality System Regulation CanadianMedical Device Registration IVD Directive / Regulation and other applicable country specific regulations) and applicable quality standards (MDSAP ISO9001 ISO13485 etc. and enhances stakeholder value. Responsible to provide expert guidance to all levels (regarding tools techniques management systems) for Quality assurance Quality control compliance and continuous Quality improvement. Ensures products and services are developed manufactured tested and delivered according to established procedures meeting Quality requirements. Position is also responsible to organize lead and develop the operations of Quality.

Responsibilities:

• Serve as the Management Representative for the SLCMurray facility and provide the facility with QMS expertise. Lead assessments of the Quality systems for compliance ensuring such assessments are conducted in accordance with established policies and procedures to maximize their benefit to bioMrieux Inc.
• Responsible to develop plan and lead the implementation of the Quality System for the Site. Once implemented to manage and continuously improve the QMS. Ensure that written procedures are maintained to define the specifications and procedural requirements affecting product Quality and that effective change controls for processes & equipment are maintained to assure that any changes are thoroughly reviewed and shown to be appropriate including review for their potential to affect validations or regulatory submissions.
• Ensures products and services are developed manufactured tested and delivered according to established procedures meeting Quality requirements.
• Facilitate teams to accomplish the deliverables milestones and objectives meeting the plans and schedules ensuring that any changes to the plans are communicated and agreed to by the teams and project sponsors for the SLCMurray site. This include steams to develop and validate regulatory strategy standardize processes at North America sites as well as implement corporate Quality system processes.
• Lead the development and implementation of Quality practices with regard to validation activities at the SLCMurray site to ensure compliance with the requirements of the Quality System Regulation & Standards.
• Develop and implement Quality training plans that provide necessary organizational knowledge to achieve company objectives.
• Establish maintain and improve reports of Quality data to assist continuous improvement and assess the effectiveness of the facilities Quality system.
• Subject matter expert in regard to Design Control to own/use Quality Standards Product Development Process Product Risk Management Product Manufacturing and Control Technology Transfer and any other Product/System Life Cycle initiatives.
• Quality Engineer for Rapid Fire project(s).

Experience & Skills:

• A minimum of 12 years of relevant industry experience required.
• Must have experience leading Quality systems at a high level in a relevant regulated environment including experience directly managing regulatory audits by FDA and ISO.
• Demonstrated competence in the selection and use of Quality Engineering tools techniques and processes.
• Expert knowledge in the interpretation and application of relevant Domestic and International Regulations and Industry Standards(e.g. ISO QSR MDSAP etc..
• Certified Quality Engineering (CQE) Certified Quality Auditor (CQA) or Six Sigma Black Belt desired.
• Minimum four 4 years managing people across multiple Quality and/or RA disciplines.
• Must possess the ability to coordinate and communicate across departments and throughout all levels of the organization to ensure cooperation and alignment in Quality objectives.
• Knowledge and good understanding of regulatory requirements guidances and processes in the field of IVDs/MDs
• Ability to work in an entrepreneurial environment