BioFire Diagnostics, LLC. is looking for a Metrologist II to join our Quality team! This is a full-time exempt position. The Quality Metrologist II is responsible for assisting with QA technical systems and continuous improvement programs. This is a key role in giving feedback for the design, implementation, and processing of the technical systems, acting as a liaison between Engineering and ICQC QA to develop and implement measurement techniques The person represents QA on moderately complex issues and provides process compliance support and problem resolution facilitation.
Principal Job Duties and Responsibilities:
- Perform all work in compliance with company policy and within the guidelines of the BioFire Diagnostics, LLC Quality System.
- Work with Engineering to define metrology tools as well as design and implement measurement systems for the incoming materials QA inspection team of raw materials used in production.
- Generic supervisory duties, including: Delegate duties and assure understanding of same; measure and appraise performance against job duties, objectives and projects; assist in skills/career development; provide motivating work environment and accurate feedback on performance; recommend/approve merit increases, promotions, hires and terminations. Review and approval of timekeeping records and paid time off.
- Read, understand and interpret equipment specifications, test procedures, etc. and be able to write procedures that outline the calibration and maintenance of Measurement & Test Equipment. The SOP's must conform to the national and international standards and conventions i.e. Current Good Manufacturing Practices (cGMP's), International Standards Organization (ISO), National Institute of Standards and Technology (NIST), etc.
- Perform tests in support of Validation and Qualification protocols.
- Lead teams with investigation methodologies and provide guidance on validation strategies for measurement systems.
- Define, document, and create work instruction procedures and technical reports utilizing GD&T methodologies.
- Define, document, and analyze Gauge R&R studies.
- Train and mentor incoming materials inspection team on metrology and measurement systems.
- Manage moderately complex projects as assigned.
Training and Education:
- High school diploma or equivalent is required.
- Bachelor’s degree in engineering, scientific or technical discipline plus four (4) years’ experience in engineering, technical, quality, laboratory, or medical device manufacturing position at a company that has a formal quality system (e.g. ISO13485, ISO901, GMP) to include a minimum of one (1) years leading or managing a team in engineering or technical duties. OR Eight (8) years’ experience in engineering, technical, quality, laboratory, or medical device manufacturing position at a company that has a formal quality system (e.g. ISO13485, ISO901, GMP) to include a minimum of one (1) years leading or managing a team in engineering or technical duties.
- High proficiency in computer skills in computer skills including MS Office and data analytics.
- Training in Quality Management systems is required, e.g. ISO13485, ISO9000, CMDR
- Experience with Quality Management Systems that are compliant to FDA – CFR, ISO 13485, and ISO 9001, at a minimum.
- Application and use of Continuous Improvement and QA tools—(Pareto, flow charts, Ishikawa, process capability, histogram, etc.) a plus.
- Experience in data collection, trending, creation, and implementation of SPC methodologies.
- Experience utilizing Six Sigma methodologies.
- Basic metrology tool programming experience preferred, i.e. CMM.
- SPC methodologies.
- Development of trends and measurement charts.
- Defining, designing, and writing procedures.
- Knowledge and experience with parts drawing interpretation and tool application preferred.
- Flowcharting of procedures and processes required.
- Creating and giving training presentations.
- Attention to detail.
- Intermediate to professional level technical writing skills.
- Advanced Microsoft application skills (i.e Excel, Word, PowerPoint, Visio).
- Statistical software experience (e.g MiniTab, JMP, R Script) preferred.
- Effective verbal and written communication skills.
- Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations.
- Ability to write reports, business correspondence, and procedure manuals.
- Ability to effectively present information and respond to questions from groups of managers, clients, customers, and the general public.
- Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists. Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form.
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.