Quality Engineer
Location: Lombard, IL, United States
Position Type: Unfixed Term
Job Function: Manufacturing
A world leader in the field of in vitro diagnostics for more than 60 years, bioMérieux 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
The Quality Engineer will execute such actions (QE Evaluations, Cause Investigations, Corrective or Preventative Actions, Corrections, QMS Tasks) in addition to investigate customer complaints, initiate and complete change controls, and ensure compliance with site, regional, and global standards.
The QE will perform one (at minimum) site process or operational audit. Supports external audits from regulatory agencies and customers as needed. Drives continuous improvement and manages projects as appropriate.
Primary Duties:
- Perform all work in compliance with company quality procedures and standards. Performs other duties as assigned.
- Maintain compliance of Quality System elements applicable to the site/function (Complaints, Quality Events, Third Party Audits, Internal Audits, Change Control, Training);
- Investigate product failures for deviations, technical customer complaints, and CAPAs to identify, confirm and address root cause.
- Complete Quality requirements for batch record release.
- Serve as back up to the QA Supplier Management Lead.
- Support the validation process from the Quality perspective.
- Maintain compliance to quality standards for all new and existing products.
*The position does not have employees to supervise or an operating budget.
Qualifications:
- Bachelor’s degree required. Preferably, in a field of science or technology
Experience:
- Minimum 3 years of relevant industry GMP experience (preferably in Quality).
- One (1) year of engineering or investigative experience.
- Experience with GMP systems regulated by ISO or government agencies.
- Knowledge or experience with risk management.
- Advanced technical writing skills.
- Strong leadership and communication skills.
- Experience with Microsoft suite and TrackWise Digital.
- Certified Quality Engineer (CQE) or Certified Quality Auditor (CQA) desired.
Knowledge, Skills, and Abilities:
- High end critical thinking, technical knowledge of microbiology and/or GLP, and time management.
- Computer skills required, including Microsoft Word, Excel, PowerPoint, and Outlook. Electronic Quality Systems such as LIMS, Blue Mountain Regulatory Asset Management, and SAP experience preferred.
- Excellent interpersonal skills and ability to work with all levels of an organization
- Ability to work effectively and efficiently toward goal completion in a complex, diverse environment with multiple and changing demands
- Must be able to work effectively in a team based environment.
- Detailed oriented.
- Strong analytical and problem-solving skills. Ability to translate written instructions, work orders and specifications.
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).
