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Associate Director, QA/QC Instruments

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Location: Saint Louis, United States
Position Type: Unfixed Term
Job Function: Quality

A family-owned company, bioMérieux has grown to become a world leader in the field of in vitro diagnostics. For almost 60 years and across the world, we have imagined and developed innovative diagnostics solutions to improve public health. Today, our teams are spread across 44 countries and serve 160 countries with the support of a large distribution network. This includes our SLC site, formerly known as BioFire Diagnostics.

 

 

Position Summary

As an Associate Director of our Instruments Quality Team, you will be responsible for leading the efforts to continuously improve the manufacturing of products and services provided in accordance with government regulations (FDA-Quality System Regulation, Canadian-Medical Device Registration, IVD Directive and other applicable country specific regulations) and applicable standards (ISO-9001: 2000 & ISO 13485, etc.), and enhance stakeholder value.  You will ensure products and services are developed, manufactured, tested and delivered according to established procedures that will assure that they meet all quality requirements, both functionally and from a compliance standpoint. You wil have the authority and responsility to perform as the facility Management Representative. 

 

 

Primary Duties:

 

  1. Serve as the Management Representative (or backup 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.
  2. 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.
  3. Support the execution of the North America Management Review and Internal Audit Program and implementation of the Corporate Quality Manual, Directives and processes.
  4. Assist and develop the implementation of Corrective and Preventive Action programs including necessary procedures, records, manuals, and trend reports.  These programs lead to process, product and service improvements.
  5. Ensure that written procedures are maintained to define the specifications and procedural requirements affecting product quality, and that effective change controls are maintained to ensure that any changes are thoroughly reviewed and appropriate, including review for their potential to affect validations or regulatory requirements.
  6. Ensure the development and implementation of inspection and operational procedures.
  7. Establish and adhere to departmental operating budget, guidelines and practices.
  1. Maximize the utilization of resources in a way that ensures the quality of received materials and finished goods while meeting budgetary goals.
  2. Monitor and control the timlieness and efficiency of QC functions.
  3. Provide methods to communicate the quality status of materials and processes to internal customers, management, and external suppliers.
  4. Ensure that department operation and practices comply with OSHA, material handling, and facility safety requirements.
  5. Review and approve validation protocols and final reports, as needed.
  6. Ensure the nonconforming material systems are effectively implemented and maintained.
  7. 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.  Monitor and maintain the department personnel and material resources to meet departmental commitments.
  8. 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 quality objectives.
  9. Develop and implement Quality and compliance training programs that provide necessary organizational knowledge to achieve company and regulatory objectives including compliance
  10. Establish, maintain and improve reports of quality data such as 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.
  11. Responsible for disposition of product, and ensures released product meets specifications and quality requirements

 

Knowledge, Experience and Skills:

  1. Requires Bachelors Degree with twelve (12) years industry experience in a related industry. 
  2. Must have experience and demonstrated ability to lead teams.  Five (5)+ years experience managing large groups is highly preferred.
  3. Must have excellent interpersonal skills, with the ability to effectively communicate written and orally.
  4. Experience in directly managing regulatory audits by FDA and ISO.  Competence in the selection and use of Quality Engineering Tools and Techniques. 
  5. Expert knowledge in the interpretation and application of relevant Domestic and International Regulations and Industry Standards (e.g. ISO, QSR, UL, CSA, VDE, etc.)
  6. 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.

bioMérieux welcomes applications from all individuals, regardless of race, national origin, gender, age, physical characteristics, social origin, disability, union membership, religion, family status, pregnancy, sexual orientation, gender identity, gender expression or any unlawful criterion under applicable law. We are committed to treating all applicants fairly and avoiding discrimination.

BioMérieux Inc. and its affiliates are Equal Opportunity/Affirmative Action Employers. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, protected veteran or disabled status, or genetic information. Please be advised that the receipt of satisfactory responses to reference requests and the provision of satisfactory proof of an applicant’s identity and legal authorization to work in the United States are required of all new hires. Any misrepresentation, falsification, or material omission may result in the failure to receive an offer, the retraction of an offer, or if already hired, dismissal. If you are a qualified individual with a disability, you may request a reasonable accommodation in BioMérieux’s or its affiliates’ application process by contacting us via telephone at (385) 770-1132, by email at [email protected], or by dialing 711 for access to Telecommunications Relay Services (TRS).

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