JOB TITLE: Manager Quality Assurance & Quality Control
Division & Business Unit: bioMerieux, Inc.
Location: Portland OR
Immediate supervisor title: Sr. Manager, PPM QA/QC

1. PRIMARY PURPOSE AND OVERALL OBJECTIVE OF THE JOB

To lead the bioMérieux facility efforts to develop, implement and continually improve systems to ensure customer requirements are implemented into company products and services provided, operational compliance with government regulations (FDA-Quality System Regulation, Canadian-Medical Device Registration, IVD Directive and other applicable country specific regulations) and applicable standards (ISO-9001 & ISO 13485, etc.), and enhance stakeholder value. Ensures products (including services) are developed, manufactured, tested and delivered according to established procedures that will assure that they meet all quality requirements.

2. CONTEXT OF THE JOB AND MAJOR CHALLENGES

Designs and manages quality programs to facilitate continual improvement actions. Ensures organizational compliance with governmental regulations and applicable standards in concert with function executives and managers. Selects programs, organizes deployment, and creates educational materials for continuous quality improvement and compliance activities. Determines compliance status of operating departments and recommends corrective/improvement actions.

3. DIMENSIONS OF THE JOB

The majority of interaction is with middle and upper management across all company divisions. This position is the primary contact for external inquiries (e.g. FDA, ISO Registrar, and customers) regarding the facility quality system. The position directly affects the efficiency and effectiveness, and hence, the profitability of the overall business.

4. MAIN ACCOUNTABILITIES

1. Serve as the Management Representative 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.
2. Responsible for the execution of the Quality System Management Review process to determine the effectiveness of the site quality system.
3. Responsible for the development, maintenance and implementation of the Complaint Investigation, CAPA and Audit Processes.
4. Ensure all activities of the Quality Control departments are executed in a timely manner including inspection, laboratory testing, document review, lot release, environmental monitoring and product stability program.
5. 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.
6. Identify the key personnel needed to address opportunities, establish resources appropriate to the projects, and determine actions that will be followed to accomplish the established objectives.
7. 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.
8. Develop and implement Quality and compliance training programs that provide necessary organizational knowledge to achieve company and regulatory objectives including compliance.
9. 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.

5. KNOWLEDGE AND EXPERIENCE

1. Bachelors Degree with 10+ years industry experience or equivalent experience in related industry.
2. Masters Degree preferred.
3. Minimum of 5 years managerial experience.
4. Ability to effective communicate written and orally.
5. Experience in directly managing regulatory audits by FDA and ISO. Competence in the selection and use of Quality Engineering Tools and Techniques.
6. Expert knowledge in the interpretation and application of relevant Domestic and International Regulations and Industry Standards (e.g. ISO, QSR, UL, CSA, VDE, etc.)
7. Certified Quality Engineering (CQE), Certified Quality Auditor (CQA), CBA (Certified Biomedical Auditor), CMQ/OE (Certified Manager of Quality / Operational Excellence) or Six Sigma Black Belt desired.