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Associate Staff Quality Engineer, Reagents

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: 

Leads efforts to improve the quality system in accordance with applicable regulatory standards.  Ensures products and services are considered state of the art by developing, manufacturing, testing according to the most current industry best practices.  Acts as quality SME for project engineering, internal/external audits, continuous improvement, CAPA investigations, and CAPA actions.  Provides quality engineering support in the areas of deviation management, change control, internal auditing, quality trends, quality costs, training, corrective and preventive actions, process control, customer complaints, calibrations, documentation control to ensure compliance with the FDA and other regulatory requirements. 

 

Primary Duties:

  1. Provide quality subject matter expertise for all areas that require a quality SME including engineering, manufacturing, investigations, audit defense, etc.
  2. Use expert level knowledge of the product and manufacturing process, ensure data driven decisions are utlized to drive science based quality judgements
  3. Lead root cause analysis and other problem-solving activities while recommending process corrective actions
  4. Work cross functionally across global sites and maintains relationships with global departments
  5. Actively maintain knowledge base of current industry best practices and industry trends
  6. Develop and implement statistically valid design of experiments (DoE), capability studies, SPC and trend analysis in support of products and service improvements
  7. Review periodic trend reporting as required (QSMR, Continuous Process Verification), identifies negative trends and recommends appropriate action.
  8. Lead risk assessment activities, reviews/revises existing risk assessments through process feedback, and identifies gaps for risk management activities
  9. Participate in regulatory and agency inspections, audits, and investigations. Acts as quality expert and interacts directly with auditors. 
  10. Provide expert support in site CAPA activities, including analysis of data and trends, nonconforming material, complaints, training effectiveness, and root cause analysis.  Leads the implementation of corrective actions and preventive measures as needed.
  11. Provide quality expert support for continuous improvement projects as needed.
  12. Provide mentorship to less experienced quality engineers

 

Knowledge, Experience, and Skills: 

  1.  Bachelor's Degree in a scientific or engineering field and a minimum of 10 years related experience OR a Master's Degree in a scientific or engineering field with a minimum of 5 years experience.
  1. Medical device or other FDA regulated industry experieience required
  2. Must posses effective written and verbal communication skills.  Must be able to communicate effectively across all levels of management including executive level.
  3. Requires strong computer skills including Microsoft Office Package (Excel, Word, etc.).
  4. Must have a expert knowledge of the interpretation and application of relevant Domestic and International Regulations and Industry Standards (MDSAP, 21CFR820, ISO 13485, QSR, etc.).  ASQ Certification in at least one of the following is desired:  CQE, CSQE, CRE, CQA, CBA, or Six Sigma Green Belt.

 

 

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.

Please be aware that recruitment related scams are on the rise. Fraudulent job postings are being placed on other websites, and individuals posing as bioMérieux Talent Acquisition team members are reaching out via email or text message in an attempt to collect your personal and confidential information. In some cases, these scammers are also conducting bogus interviews prior to extending fraudulent offers of employment. Beware of individuals reaching out using general phone numbers and non-bioMerieux email domains (i.e. Hotmail.com, Gmail.com, Yahoo.com, etc.). If you are concerned that an interview experience or offer of employment might be a scam, please make sure you are searching for the posting on our careers site https://careers.biomerieux.com/ or contact us at [email protected].

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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