Quality Management Representative/Quality 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 (FDA-Quality System Regulation, Canadian-Medical Device Registration, IVD Directive / Regulation and other applicable country specific regulations) and applicable quality standards (MDSAP, ISO-9001, ISO-13485, 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:

• Establish, maintain and improve reports of Quality data to assist continuous improvement and assess the effectiveness of the facilities Quality system.
• Develop and implement Quality training plans that provide necessary organizational knowledge to achieve company objectives.
• 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.
• Ensures products and services are developed, manufactured, tested, and delivered according to established procedures meeting Quality requirements.
• Serve as the Management Representative for the SLC-Murray 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 bioMérieux, 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.
• Lead the development and implementation of Quality practices with regard to validation activities at the SLC-Murray site to ensure compliance with the requirements of the Quality System Regulation & Standards.
• Quality Engineer for Rapid Fire project(s).
• 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 SLC-Murray site. This include steams to develop and validate regulatory strategy, standardize processes at North America sites as well as implement corporate Quality system processes.

Experience & Skills:

• Demonstrated competence in the selection and use of Quality Engineering tools, techniques, and processes.
• 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.
• A minimum of 12 years of relevant industry experience required.
• Knowledge and good understanding of regulatory requirements, guidance's and processes in the field of IVDs/MDs
• Minimum four (4) years managing people across multiple Quality and/or RA disciplines.
• 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.
• Ability to work in an entrepreneurial environment
• 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.