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Quality Engineer

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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:

Responsible for the implementation and maintenance of effective Design Controls in accordance with FDA Quality Systems Regulation, ISO 9001, ISO 13485, and other applicable country specific regulations.    Participates on quality improvement teams for quality assurance, compliance, and continuous improvement. Ensures products and services are developed and tested according to established procedures that will assure they meet quality requirements.

 

Responsibilities:

  • Assist in the documentation of quality systems and programs in the areas of training, change management, validation, design controls, CAPA, etc. to ensure compliance with FDA and regulatory requirements.
  • Quality Engineering Support for Design Control Process – Implement project risk management planning as needed.  Facilitate and participate in design reviews, develop quality engineering deliverables and assure Design History File (DHF) is updated as necessary.
  • Serve as contact for assigned project(s) and provide coaching / mentoring to project managers and/or project team regarding the product development process, design control (e.g. risk assessment), etc.
  • Review and provide feedback on product documentation to support the product development process.
  • Serve as a chairperson or committee member for technical or specialty design review(s) during product development or serve as chairperson for change management process.
  • Provide input to quality training programs as requested, and assist in providing training for Design Controls.

 

Studies and Experience:

  • Requires a minimum of three (3) years experience in a related industry regulated by FDA and/or ISO.
  • Requires demonstrated competence in the selection and use of Quality Engineering tools, techniques, and processes.
  • Must possess 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 (CBA), or Six Sigma Black Belt.
  • Requires effective written and oral communication skills to interact across all levels of the organzation.
  • Must have experience in and knowledge of Microsoft Office Package (Word, Excel, etc.).

 

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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