Lead the St. Louis facility efforts to develop, implement, and continually improve systems to ensure customer requirements are implemented into company products and services provided. Ensure operational compliance with government regulations (FDA-Quality System Regulation, Canadian-Medical Device Registration, IVD Directive and other applicable country specific regulations) and applicable standards (MDSAP, ISO-9001, ISO-13485, etc.), and enhances stakeholder value. 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. Responsible to organize, staff, lead, and develop the operations of the Quality Department.
- Serve as the Management Representative for the St. Louis facility and lead assessments of the Quality systems for compliance (e.g. customers, FDA, ISO Registrars, MDSAP), ensuring such assessments are conducted in accordance with established policies and procedures to maximize their benefit to bioMérieux, Inc.
- 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.
- 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.
- 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 as well as implement corporate Quality system processes.
- Lead the development and implementation of Quality practices with regard to validation activities at the St. Louis site to ensure compliance with the requirements of the Quality System Regulation, ISO-9001, ISO13485, MDSAP, 21 CFR Part 11, and the Directive on In Vitro Diagnostic Medical Devices (IVD).
- Recruit, direct, and develop employees who will function well within our culture. Evaluate, coach, and engage employees to ensure job satisfaction. Encourage staff to take initiative, be proactive, and to strive to improve their work and the processes that shape their work.
- 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.
Studies and Experience:
- Master's Degree with a minimum of 12 years of relevant industry experience required.
- A Bachelors Degree with a minimum 15 years relevant industry experience leading Quality systems will be considered in lieu of the Masters Degree requirement.
- Minimum four (4) years managing people across multiple Quality disciplines.
- 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.
Skills and Qualifications:
- 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.
- 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.