Quality Engineer
Description
- Work within the framework of the site quality management system to ensure compliance across the operation.
- Assist other departments and employees with initiating and completing quality event documentation including: nonconformances, temporary deviations, and corrective and preventative actions (CAPA).
- Collaborate with the purchasing department to validate and approve suppliers and maintain records associated with the supplier quality management process.
- Performs a wide variety of inspection, risk mitigation, and audit activities.
- Responsible for maintaining site-wide quality assurance KPIs.
- Assist with continuous improvement programs/projects to improved compliance to regulatory and industry standards.
- Cooperate with the rest of the Quality team to address quality-related projects and initiatives across the site.
- Support the quality assurance team with routine work centered around continuous process improvement using a risk-based approach.
- HS Diploma and a minimum of 5 years of experience years of experience in a quality-regulated manufacturing industry required.
- OR Associates and a minimum of 4 years of experience in a related field will be accepted in lieu of the degree
- OR BA/BS Degree in a life science or related field and a minimum of 3 years of experience in a quality-regulated manufacturing industry required.
- OR Masters’ degree with 1 year or more of experience preferred.
- Prior experience with Quality Management System procedures support in a quality department preferred.
- Familiarity / knowledge of the interpretation and application of relevant domestic and international regulations and industry standards (ISO9001, ISO13485, ISO17025) is preferred.
- Experience managing nonconformances, deviations, corrective / preventative actions, and investigation writing preferred
- Competence in the use of Quality Tools and Techniques and knowledge of quality systems (SAP/LIMS/Trackwise) is a plus.
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 recruitment@biomerieux.com.
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 recruitment@biomerieux.com, or by dialing 711 for access to Telecommunications Relay Services (TRS).