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
+ 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.
+ 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
+ Advanced Microsoft application skills (i.e Excel, Word,
+ Statistical software experience (e.g MiniTab, JMP, R Script)
+ Effective verbal and written communication skills.
+ Ability to read, analyze, and interpret general business
periodicals, professional journals, technical procedures, or
+ Ability to write reports, business correspondence, and
+ Ability to effectively present information and respond to
questions from groups of managers, clients, customers, and the
+ 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.
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.