CAPA Administrator
This job posting is no longer active.
Location: Salt Lake City, UT, United States
Position Type: Fixed-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.
Description
At BioFire Diagnostics, LLC. we make the world a healthier place by providing molecular solutions that lessen the time to medical results and empower healthcare professionals to make better diagnostic decisions.
We are proud to be part of the bioMérieux family and the 5,000+ team members across 12 sites and subsidiaries in North America committed to our mission to help save lives around the globe through the power of diagnostics.
Come be a part of our team and our mission as a Quality Engineer II!
Principal Job Duties and Responsibilities:
This position will play a key role giving feedback for the design, implementation, and processing of the technical systems, including for example, CAPA, NCR and Quality Plans system. This person will be working with BioFire employees outside of QA on a day to day basis and must have a customer focused attitude. The person represents QA on complex technical and process issues. They are an advisor to assist resolving problems where they support specialty experts and guide process compliance.
Essential Job Duties and Responsibilities
- Performs all work in compliance with company policy and within the guidelines of the BioFire Diagnostics, LLC Quality System.
- Perform duties of a Quality Engineer I without direct supervision.
- Lead CAPA and other programs through complex and non-complex projects to ensure the following:
- Appropriate process and compliance issues are followed
- Teams maintain prompt progress towards closure
- Lead teams with investigation methodologies and provide guidance on validation strategies
- Document CAPA and Quality Plan activities. Communication to senior leaders as needed.
- Manage small projects where appropriate.
- May study, develop and report metrics on projects.
Supplemental Data
This is mid-level position with room for growth and additional responsibility as skills are demonstrated.
Qualifications
Training and Education
- Required – Bachelor’s Degree in a related field. Minimum ten years professional experience in a related field plus ASQ Certification (CQE) or Six Sigma Black Belt may be considered in lieu of a degree.
- ASQ Certified Quality Engineer preferred.
Experience
- Experience: Three of more years in an Engineering, Scientific or Investigative role is required
- Experience with Quality Management Systems that are compliant to FDA – CFR, ISO 13485, ISO 9000, and CMDR at a minimum.
- Application and use of Continuous Improvement and QA tools (Pareto, flow charts, Ishikawa, process capability, histogram, 8D etc.) a plus.
Knowledge, Skills and Abilities
- Experienced in conducting problem investigations
- Development of Trends and Measures
- Writing procedures, flowcharting
- Ability to collaborate cross-functionally
- Application of Quality Risk Management principles
- Project leadership skills
- Creating and giving training presentations.
- Attention to detail (e.g. document reviews, investigation write ups).
- Intermediate level technical writing skills
- Ability to identify and calculate appropriate statistical methods for non-complex problems. Ability to communicate with Statisticians and perform statistical calculations as instructed. Wisdom to seek help when needed.
- Proficiency in MS Office tools, including Outlook, Word, and Excel
Physical Requirements
.
Must be able to lift at least 25 lbs and may be required to lift up to 50 lbs. Must be able to sit or stand for moderate amounts of time and look at computer monitors for an extended amount of time with or without accommodation.
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).
