Staff Quality Engineer - Software
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 Quality Systems in accordance with FDA Quality Systems Regulation, ISO 9001, ISO 13485 and other applicable country specific regulations. Participates and provides guidance to software development project teams on tools, techniques and management systems for quality assurance, compliance, and continuous quality improvement. Ensures software-related products (including services) are developed, tested and delivered according to established procedures that will assure that they meet all quality requirements.
Primary Duties:
- Provide guidance and support to software project teams regarding application of Design Control; format and content of Verification/Validation Plans and Summary Reports; and practices associated with conducting Product Risk Analysis and Design Failure Mode & Effects Analysis (dFMEA).
- Provide guidance and support regarding verification methodologies and practices including source code reviews, unit & module testing, system/software integration testing, regression testing, application of automated test tools.
- Additionally, provides guidance and support for methods for investigation for root cause associated with complaints and Field Actions and software related quality process improvements.
- Provides program support (software related) such as: core team representation, finds solutions when unforeseen events occur in Design Control, and provides direction for Scalability.
- Provides support for Phase Design Reviews on software development projects, ensuring the traceability of data presented for the review and maintenance of the DR process integrity.
- Participates in the Design History File (DHF) Audits, Corporate Quality Audits, and provides guidance to third party audits as needed.
- Participates in the Anomaly Review Board and Change Review Board assessment activities.
- Provide guidance and support to the Complaint Handling Process regarding analysis and assessment of software related complaints.
Position Requirements:
- Bachelors Degree with 8+ years of experience peforming primary duties in a related industry
- Must have experience authoring Software Requirement Specifications, participating in the architectural design of a system, software verification / validation, troubleshooting and root cause investigation.
- Also requires knowledge of conducting Design Failure Mode and Effects Analysis (DFMEA) for components/subsystems.
- Requires effective written and oral communication skills to interact across all levels of the organization.
- Must have experience in and knowledge of Microsoft Office Package (Word, Excel, etc.).
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).
