Job Information
BIOMERIEUX, INC. Sr Specialist Quality and Regulatory Compliance in SALT LAKE CITY, Utah
Sr Specialist Quality and Regulatory Compliance
Location: Salt Lake City, UT, United States Position Type: Unfixed Term Job Function: Quality
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A world leader in the field of in vitro diagnostics for more than 60 years, bioMerieux provides diagnostic solutions which determine the source of disease and contamination to improve patient health and ensure consumer safety. In North America we have more than 6,200 team members across 11 sites or subsidiaries, including Salt Lake City-based BioFire Diagnostics and one subsidiary in Montreal, Canada. Come and join a family-owned global company with a long-term vision, and a human-centered culture.
Description Position Summary: Develops practical and innovative ways to identify and meet short, mid-term goals and have the understanding and experience to execute business objectives. This position is structured to allow flexibility including remote work and on site when required. This role can be locates in either the Salt Lake City, UT or Durham, NC areas requiring anticipated 50% onsite presence. Primary Responsibilities: * Executes assigned quality projects, with guidance from Sr. Manager, using engineering principles, business standards, practices, procedures, and project requirements. * Assures proper documentation of technical data generated for the assigned projects and/or tasks consistent with applicable quality directives and procedures. * Documents quality systems and programs to ensure compliance with local / global regulatory requirements and corporate quality systems requirements. * Participates in the following activities contributing to QMS compliance: CAPA (including analysis of data and trends in complaints, nonconforming materials and root cause analysis), change control, supplier quality, internal audits, quality training, QSMR, Risk Assessments, etc. * Participates and communicates status, business issues, and significant developments in projects. Education/Skills/Experience: * Bachelor's degree with 4 years of experience in Quality Assurance or Quality Engineering. In lieu of a degree, a High School Diploma/GED with 7 years of experience also considered. * Technical Writing (CAPAs, Deviations, Doc Control) experience preferred * ISO 13485 and /or 9001 experience highly preferred, with experience as a Lead Auditor desired * MDSAP experience preferred * Experience in Pharma or Medical Device industries preferred * CQA or CQE certification preferred * Competence in the selection and use of Quality Engineering Tools and Techniques. * Requires computer skills including Microsoft Office Package (Excel, Word, etc.). #LI-US
Please be aware that recruitment related scams are on the rise. Fraudulent job postings are being placed on other websites, and individuals posing as bioMerieux 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 recruitment@biomerieux.com. BioMerieux 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,... For full info follow application link.