Sr Director, Microbiology Product Quality
Hazelwood, MO, US
10 days ago
Company: bioMerieux
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Description
Position Summary:
We are looking for a Sr. Director, Product Quality who will evolve within the Quality department and will report to the Senior VP of Pre and Post Market Quality within a team of 12 co-workers. Through the use of strategic thinking, study design expertise, and an ability to navigate and align stakeholders, the Sr. Director will facilitate cross functional approaches to address identified product trends/issues and investigate to ensure proper reporting to executive management and regulatory agencies, continual assessment of benefit-risk ratios and product safety/effectiveness, as well as providing feedback for future development needs.
Primary Responsibilities
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 BioFire Diagnostics’ 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).
Description
Position Summary:
We are looking for a Sr. Director, Product Quality who will evolve within the Quality department and will report to the Senior VP of Pre and Post Market Quality within a team of 12 co-workers. Through the use of strategic thinking, study design expertise, and an ability to navigate and align stakeholders, the Sr. Director will facilitate cross functional approaches to address identified product trends/issues and investigate to ensure proper reporting to executive management and regulatory agencies, continual assessment of benefit-risk ratios and product safety/effectiveness, as well as providing feedback for future development needs.
Primary Responsibilities
- Accountable for the quality level of the product range throughout product lifecycle management starting with the support of the development of the product, approval of the product risk analysis files, management of vigilance and field actions activities.
- Responsible for issuing the post market quality reports defining if the product is still state of the art and if any support post launch is needed.
- Provide visibility on the quality level of the product range to the top management and propose action to maintain it at the right level for our customers and patients.
- Responsible for keeping up with bioMerieux's growing market and product lines, and the ever-evolving global quality landscape.
- Ensure adherence to policies and drive implementation of the all quality processes especially product risk files, Product Development Process, assessment for potential adverse events, field actions and Post Market Surveillance, as well as compliance with Corporate and external requirements (e.g. applicable standards and regulations, Distributors management).
- Oversee the direction and development of the product quality team
- Bachelor's degree in Science or Engineering
- 10+ years in quality vigilance/field actions, design control, or equivalent
- 5+ years leading projects and directly managing other employees.
- Medical Device/IVD industry preferred
- Excellent verbal and written communication skills.
- Demonstrate success in supporting both growth and product support projects, including complex projects involving ambiguity, in a rapidly changing regulatory and quality environment.
- Comprehensive knowledge of regulations applicable to medical device/IVD industry with an expertise on vigilance, field actions and design control ones. Must be able to interpret regulatory and quality requirements (QSR, IVDR, ISO 13485 / ISO9001 and/or local GMPs if appropriate). Experience in participation in the management of regulatory audits (i.e. ISO 9001, 13485, FDA, etc.); Knowledge in the interpretation and application of relevant Domestic and International Regulations and Industry Standards (e.g. ISO, QSR, UL, CSA, VDE, etc.).
- Ability to inspire, motivate, and build the confidence of teams to reach goals, consistently pushing self and others to achieve results.
- Ability to influence peers, higher leaders and external expert or regulatory bodies.
- Must demonstrate strong leadership skills
- Ability to analyze and use data to drive decisions and process improvements. Familiar with product profiles and technology, company organization and processes will be a plus.
- Ability to travel as needed
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 BioFire Diagnostics’ 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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