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Location: Salt Lake City, UT, United States
Position Type: Unfixed Term
Job Function: Quality
A family-owned company, bioMerieux 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.
Description
Perform all work in compliance with company policy and within the guidelines of BioMerieux's
Quality System.
2. Establish supplier audit schedules and activities.
3. Perform gap analysis of supplier QMS to new and existing regulations and standards.
4. Present supplier audit findings at annual Management Review meeting.
5. Present supplier audit findings and OFI's to Supplier Program Manager, and members of Supplier Review
Board/Material Review Board.
6. Understand company organization, operations, product development cycle and management processes.
7. Understand QMS organization and QA functions.
8. Maintain supplier audit finding database (SCARs).
9. Evaluate supplier audit findings and opportunities for improvement.
10. Review supplier audit findings and opportunities for improvement for trends over time.
Supplemental Data
1. 5-10% Domestic and/or international travel may be required for training purposes.
2. 10-20% domestic and/or international travel may be required for performing supplier audits
Note: Travel may be restricted during times of high risk to travelers. Supplier audits may be performed remotely
as deemed necessary by management
- Bachelor of Science or Master's Degree (science, engineering or life sciences).
2. Knowledge of good manufacturing practices, ISO 9001, ISO 13485, and 21 CFR 820 required.
3. Knowledge of quality principles and regulations applicable to in vitro diagnostic products, including FDA
QSR, ISO 13485, CMDR, CE Marking, ISO 9001, ISO 14971, In Vitro Diagnostic Directive/In Vitro Diagnostic
Regulation.
4. Knowledge of MDSAP audit program a plus.
Experience
1. Minimum 5 years work experience in Medical Device, Pharmaceutical or Biotechnology manufacturing
setting that has a formal quality system is required.
2. Auditing experience in Medical Device, Pharma, or Biotechnology industry.
Knowledge, Skills, and Abilities
1. Effective written and verbal communication skills
2. Proficiency in MS Office tools, including Outlook, Word, and Excel
3. General computer operation
4. Proficiency in internet navigation
5. Attention to detail is fundamental to this position
6. Strong organization is required
7. Auditing principles and best practices
8. Ability to accurately follow and interpret written procedures
9. Ability to accurately comprehend and interpret federal and international regulations and standards.
10. Excellent communication skills, both oral and written
11. Excellent collaboration with cross-departmental leaders within the organization.
12. Professional communication and peer-to-peer interactions is a must.
13. Critical listening skills
14. Experience with MS Visio a plus
15. Ability to prepare clear and concise summaries for executives and stakeholders.
16. Strong presentation skills.
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 or contact us at .
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, 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 BioMerieux's or its affiliates' application process by contacting us via telephone at (385) 770-1132, by email at , or by dialing 711 for access to Telecommunications Relay Services (TRS).