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Global Quality System Expert

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Location: Salt Lake City, 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.

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.
Come and join a family-owned global company with a long-term vision, and a human-centered culture.

 

 

 

The Global Product Development Process Expert reports operationally to the Director,  Global Quality, Product Development and Lifecycle Management. 

 

The role supports the Global Pre-Market Quality organization to ensure adherence to Quality System regulatory requirements and applicable standards. 

 

Strong interpersonal and communication skills, and quality experience is required to closely partner with stakeholders within bioMerieux to drive continuous improvement initiatives specifically related to the Product Development Process, and interfaces with the Product Risk Management and Post-Market Surveillance System Processes.  Main functional stakeholders include R&D Units, Programs, Global Customer Service, and Manufacturing site Quality. The position is responsible for providing compliant and pragmatic processes and solutions to support these Processes.  

 

 

What will be your responsibilities at bioMérieux?

 

The Global Product Development Process Expert is responsible for the following primary activities:

 

  • Global technical expert for design controls, compliance, and continuous quality improvement in R&D Product Development Process
  • Influence and help with the design control understanding and PDP implementation for minimum and valuable effort
  • Develop and apply design control audit strategy
  • Support operational premarket quality for appropriate application of design control/Product development processes, methodology (risk management, scalability, V&V, etc) and continuous improvement actions
  • Link with operational premarket quality in order to ensure feedback and global approach to PDP application are taken into account in progress plans
  • Participate to governance definition in partnership with the Global Director Quality Design Control
  • Participate to standard watch strategy and to implementation of new standards in PDP
  • Act as super expert in the training creation, ensuring training needs are fulfilled and messages are aligned with PDP and Design Control.
  • Facilitate as requested project group meetings for PDP implementation
  • Support internal and external audits / inspections, and Lead global assessments as needed for Product Development processes
  • Partner with R&D Function Leaders/Managers to ensure functional excellence
  • Align Product Development Quality objectives with global Quality objectives

 

Who are you?

 

  • Bachelor’s degree in a technical or life science (e.g., biology) area desired,
  • You have more than 10 years of experience mostly in In-vitro Diagnostic industry or related industry (Pharmaceutical industry, medical devices for example),
  • You have more than 5 years of Quality experience desired particularly in design control,
  • You have a strong leadership and communication skills,
  • You have the ability to multitask and provide direction/guidance by providing logical and least burdensome approach to fix quality issues and assist in the implementation of the needed improvements,
  • You have an open minded leadership able to understand differences between sites and work openly with all bioMérieux R&D countries (Think globally but with capability of local implementation),
  • You have a strong experience in participation in the management of regulatory and certification audits,
  • You are an expert knowledge in the interpretation and application of relevant Domestic and International Regulations and Industry Standards.

​​​​​​​

The Quality Expert will maintain a Global perspective, understanding the regulatory context and integrate political, economic, social, technical, and cultural environments when driving solutions and/or improvements.

 

 

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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