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Position Summary:

Designs and manages quality programs to develop, implement, and continually improve systems to ensure customer requirements and implemented into Company products and services. Leads operations compliance with government regulations (FDA, Canadian Medical Device Registration, MDSAP, IVD Directive and other applicable regulations) and all other applicable standards (ISO, etc.). Leads a team by providing coaching, feedback, guidance, and training to employees, ensuring engaged and skilled staff.

Primary Responsibilities:

• Serve as the backup Management Representative, when management rep is unavailable, for the manufacturing facility and lead assessments of the quality systems for compliance (e.g. customers, FDA, ISO Registrars), and ensure that such assessments are conducted in accordance with established policies and procedures to maximize their benefit to bioMérieux, Inc.

• Lead or 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 St. Louis site. This includes teams to standardize processes at North America sites to ensure the North America ISO 9000 & 13485 registration is maintained.

• Lead or support the execution of the site Quality Management Review and Internal Audit Program and implementation of the Corporate Quality Manual, Directives and processes.

• Develop and maintain the Corrective and Preventive Action programs including necessary procedures, records, manuals, and trend reports. These programs lead to process, product and service improvements.

• Develop and maintain the customer complaint trending and complaint investigation processes including necessary procedures, records, and reports. Assure the timely response and closure of complaint investigations. Provide oversight of complaint records.

• Recruit and develop employees who will function well within our corporate culture. Evaluate and direct employees to ensure job satisfaction and improvement. Encourage staff to take initiative, to be proactive, and to strive to improve their work and the processes that shape their work.

• Configuration control and management of all documentation and data required to manufacture products produced and distributed from the St. Louis, MO. This includes the Device Master Indexes and the assignment and maintenance of Part Numbers and Bill Of Materials (BOM) in SAP. Assure that this documentation meets the requirements of 21CFRPart 820 Quality System Regulation, In-Vitro Diagnostic Directive and other country specific language requirements.

• Develop and implement Quality and compliance training programs that provide necessary organizational knowledge to achieve company and regulatory objectives including compliance

• Establish, maintain and improve reports of quality data such as customer satisfaction, business level quality, and functional area quality indicators to assist the continuous improvement of quality and analyze them to assess the effectiveness of both the company quality system. This data is included in regular reports to senior executives for the Quality System Management Reviews.

• Manage STL and San Jose risk assessments.

• Manage site compliance projects as needed

• Adhere to/Manage the department budget.

  Education, Skills, & Experience:

• Requires a Bachelors Degree in scientific field, Masters Degree preferred.

• Requires a minimum eight (8) years progressively responsible quality systems experience in a relevant industry (such as medical device). Specific qualifying experience includes understanding and implementation of ISO and CFR regulations.

• Requires a minimum of 5 years experience managing quality teams and leading people.

• Certification in one of the following is desired: CQE, CQA, CBA, CMQ/OE, or Six Sigma Black Belt.

• Requires strong computer skills including Microsoft Office Package (Excel, Word, etc.).

• Must have a expert knowledge in the interpretation and application of relevant Domestic and International Regulations and Industry Standards (ISO, QSR, UL, CSA, VDE, etc.).

• Must possess strong interpersonal, written and oral communication skills.

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