Product and Process Risk Associate Staff at Biomerieux, Inc in St. Louis, Missouri

Posted in Other 24 days ago.

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Job Description:

World leader in the field of in vitro diagnostics for over 55 years, bioMérieux conceives, develops, produces and markets diagnostics solutions (systems, reagents, software and services) intended for clinical and industrial applications, which determine the origin of a disease or a contamination to improve the health of patients and insure consumer safety.

bioMérieux is present in 43 countries and services more than 160 countries with the support of a large network of distributors. Its corporate headquarters are located in Marcy l'Etoile, near Lyon, in France.

Joining bioMérieux, is choosing to join an innovative company with a long term vision, committed to the service of public health and carried out with a humanistic corporate culture.

We look for candidates whose motivation is to invest in themselves, in the projects of the future, and to participate in a collective adventure led by a pioneering spirit.

We have the commitment to offer our collaborators a working environment which encourages team spirit, with priority given to training and development with international career opportunities.

Our Group offers numerous possibilities: so come and join the 11,200 bioMérieux employees who have already identified with these values!

Support lifecycle risk management for IVD medical device products and manufacturing processes. Responsible for periodic review of risk management files to conform with the latest state-of-the-art and assumptions of risk in conformance with ISO 14971. Leads establishment and maintenance of semi-quantitative probability criteria and application to risk during product and process lifecycle. Supports the organization's risk management goals, strategies and processes.

  • Performs assessment of appropriate risk information to support on-going Post Market Surveillance and Periodic Safety Update Reports in conformance with IVDR and ISO 14971.

  • Owns process risk assessments as needed and performs periodic review to ensure effectiveness of risk mitigation activities.

  • Facilitates risk assessment meetings, documentation of the process and decisions, and follow up of actions. Develops functional area process risk assessments in compliance with MDSAP requirements.

  • Support quality improvement initiatives related to risk management of product and process including but not limited to CAPA investigation and actions, Nonconforming material investigations, input on risk for field actions and customer complaints, maintenance of the risk management file index.

  • Update risk management summary reports as needed.

  • Perform similar device review with the support of subject matter experts in compliance with ISO 14971 and internal procedures.

  • Develop working relationships with key business partners across the firm.

  • Other duties as assigned.


Qualifications:

Required:
  • Minimum 5 years of experience in medical devices, in vitro diagnostics, pharmaceuticals, biotechnology or related industry is required with direct ISO 14971 Risk Management experience.
  • Requires working knowledge of selection and use of Quality Engineering tools, statistical analysis techniques, data trending or manufacturing process.
  • Demonstrated experience developing risk assessments (FMEA, FMECA, product safety risk, etc.) to drive improvements and/or maintain processes.
  • Requires knowledge of the interpretation and application of relevant Domestic and International Regulations and Industry Standards (e.g. ISO, QSR, IVDR, MDSAP, etc.).
  • One of the following certifications is desired for this role: Certified Quality Engineering (CQE), Certified Quality Auditor (CQA), Certified Software Quality Engineer (CSQE), Certified Reliability Engineering (CRE), Certified Biomedical Auditor (BCA), or Six Sigma Black Belt.
  • Requires effective written and oral communication skills to interact across all levels of the organization.
  • Must possess High level of attention to detail, highly motivated and organized.
  • Must have experience in and knowledge of Microsoft Office Package (Word, Excel, etc.)


  • bioMérieux is an Equal Opportunity, Affirmative Action Employer. M/F/Vet/Disability/Sexual Orientation/Gender Identity/GINA