Quality Engineer II - Day Shift
Description
BioFire is looking to add a Quality Engineer II to our growing team!
This is a full-time exempt position. The Quality Engineer II is responsible for assisting with the maintenance of BioFire Quality Assurance technical systems and continuous improvement programs. The Quality Engineer II may lead programs or quality issues that are not complex.
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.
Principal 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 NCR, CAPA and other programs through 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 NCR, CAPA and Quality Plan activities. Communication to senior leaders as needed.
- Manage small projects where appropriate.
- Lead investigations into product and material non-conformances (NCR), including problem identification, product & process quality risk assessment, root cause analysis, product disposition, remedial action, and the need for follow-up action.
- Develop inspection and sorting plans, and lead inspection activities.
- Author non-conformance reports.
- Coordinate investigation activities cross-functionally.
- Ensure timely NCR processing.
- Understand BioFire’s products, processes, and system interactions with sufficient detail to serve as a Core team member (Quality representative) for disposition and decision-making.
- Communicate complex information both verbally and in writing.
- Engage in managing quality risks associated with equipment and process changes.
Supplemental Data:
This is a mid-level position with room for growth and additional responsibility as skills are demonstrated.
Training and Education:
- Required – Bachelor’s Degree in a related field.
Experience:
- Experience: Three or more years in an Engineering, Scientific or Investigative role is required.
- Experience or Certification in Quality Management Systems for FDA – CFR, ISO 13485, and ISO 9001 preferred but not required
- Application and use of Continuous Improvement and QA tools—(Pareto, flow charts, Ishikawa, process capability, histogram, etc.).
Skills:
- Development of Trends and Measures
- Writing procedures, flowcharting
- Ability to collaborate cross-functionally
- Application of Quality Risk Management principles
- Creating and giving training presentations.
- Attention to detail
- 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.
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.
BioFire Diagnostics, LLC. is an Equal Opportunity/Affirmative Action Employer. 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 BioFire Diagnostics’ application process by contacting us via telephone at (385) 770-1132, by email at careers@biofiredx.com, or by dialing 711 for access to Telecommunications Relay Services (TRS).