Senior Quality Engineer
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:
As a Senior Technical Quality Engineer, you will be responsible for managing processes and leading projects to maintain and improve the quality system in accordance with applicable regulatory standards. Ensure products and services are developed, manufactured, tested and delivered according to the established procedures. Provide quality engineering support in the areas of project engineering, deviation management, change control, internal auditing, quality trending, continuous improvement, training, corrective and preventive actions, process control, calibrations, and documentation control. Perform all duties using safety conscious practices.
Primary Duties:
- Provide quality engineering support to manufacturing, maintenance, calibration, facilities, and project engineering departments.
- Conduct root cause analysis, leads process corrective actions and other problem-solving activities.
- Develop and implement statistically valid design of experiments (DoE), capability studies, SPC and trend analysis in support of products and service improvements
- Provide periodic trend reporting as required (QSMR, Continuous Process Verification).
- Conduct risk assessments, reviews/revises existing risk assessments through process feedback, and acts as quality representative for risk management activities
- Use data to perform statistical analysis and recommend process / product changes to improve product quality
- Provide quality support and approval signatures for Validations, Qualifications, Engineering/Scientific Studies and Technical Assessments as required.
- Support Change Control Processes through assessment of system changes and execution of activities as needed. Support CAPA, investigations, NCs, Waivers as QA function. Review Bill of Material (BOMs), Assembly Procedures, Standard Operating Procedures, Drawings, and Component Specifications.
- Perform periodic reviews on equipment and processes as needed
- Review and approve calibration exception investigations, change controls, and first article inspections. Participate in QA oversight activities for production, IND, MES, calibration, maintenance, and facilities.
- Participate in regulatory and agency inspections, audits, and investigations. Also participates in the site Internal audit and compliance review programs.
- Participate in site CAPA activities, including analysis of data and trends, nonconforming material, complaints, training effectiveness, and root cause analysis. Coordinates the implementation of corrective actions and preventive measures as needed.
13. Support continuous improvement projects as needed.
Position Requirements:
Bachelor's Degree in a scientific field
5+ years of experience in a lab, validation and/or quality role.
Medical device or other FDA regulated industry experience preferred
- Must possess effective written and verbal communication skills.
- Requires strong computer skills including Microsoft Office Package (Excel, Word, etc.).
- Must have a working knowledge of the interpretation and application of relevant Domestic and International Regulations and Industry Standards (MDSAP, 21CFR820, ISO 13485, QSR, etc.).
6. ASQ Certification in one of the following is preferred: CQE, CSQE, CRE, CQA, CBA, or Six Sigma Green Belt.
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).
