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Associate Staff Quality Engineer

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Location: Durham, 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:

The Associate Staff Quality Engineer is primarily responsible for managing the Nonconformance/CAPA systems for the Durham, NC site.  This is accomplished through tracking the process, scheduling and leading trending meetings, creating and monitoring quality performance metrics, implementation of related trainings and identifying continuous improvement opportunities.

 

Responsibilities:

  • Develop reports, utilizing statistical tools where appropriate, identify and trend KPIs.  Collect and present metrics for site scorecard and Quality Systems Management Review.
  • Oversee the site Investigator Certification Process, coach Investigators and assure adherence to SOP requirements.
  • Support and/or perform quality investigation activities, including but not limited CAPA, Complaint, and Nonconformance
  • Write, review, and approve SOPs to ensure they comply with the Quality System and current Good Manufacturing Practices
  • Chair the NC/NCMR and CAPA trending meeting, and provide summary of data analysis to cross-functional team
  • Serve as SME on NC/CAPA processes interface with customers and regulatory agencies for Inspections and Audits (MDSAP, FDA, ISO, Customer, etc)
  • Support QMS Activities by participating in cross functional projects/activities
  • Identify and implement continuous improvement activities to improve compliance to site, regulatory and industry standards.
  • Perform any additional job related duties as requested

 

Studies and Experience:

  • BA/BS Degree in a science related field preferred and a minimum five (5) years of experience working FDA regulated environment with knowledge of Good Manufacturing Practices required
  • Minimum 10+ years GMP/FDA regulated industry experience required in lieu of degree
  • Experience managing nonconformance quality system or extensive Investigation writing experience required.
  • Competence in the selection and use of Quality Engineering Tools and Techniques
  • Demonstrated ability in providing compliant and practical solutions to complex quality issues preferred

 

Knowledge, Skills & Abilities:

  • Computer skills required, including TrackWise, TWD and Microsoft Office
  • Excellent interpersonal skills and ability to work with all levels of an organization
  • Ability to work independently and in a team environment
  • Ability to prioritize and balance multiple deadlines in a fast-paced deadline driven environment
  • Ability to work effectively and efficiently toward goal completion in a complex, diverse environment
  • Ability to effectively communicate verbally and in writing; technical writing skills required

 

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).

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