Jobs
>
Salt Lake City

    Quality Engineer III - Salt Lake City, United States - BioFire Diagnostics

    BioFire Diagnostics
    BioFire Diagnostics Salt Lake City, United States

    1 week ago

    Default job background
    Description

    Position Summary

    This is a full-time exempt position. The Quality Engineer III is responsible for assisting with the maintenance of technical aspects of the Quality Management System, specifically the control of Design and Development Changes. This person will be working with BioFire employees outside of Quality Assurance on a day-to-day basis and must have a customer focused attitude. The person represents Quality Assurance on complex technical and process issues. They are an advisor to assist resolving problems where they support specialty experts and guide process compliance.

    Primary Duties

    + Performs all work in compliance with the company policy and within the guidelines of the BioFire Diagnostics, LLC Quality System

    + Perform duties of a Quality Engineer II without direct supervision

    + Lead the NCR, CAPA, validation and risk management systems to ensure the following:

    + Relevant procedures and requirements are considered and applied

    + Timely completion of activities

    + Lead and guide teams with investigation methodologies and validation strategies

    + Document notes, action item recording and follow through, and communication to senior leaders as needed

    + Manage large and/or complex projects when assigned

    + May study, develop and report Quality related metrics

    + Mentorship of lower-level Quality Engineering staff

    + Drive efficiency and consistency through continuous improvement in the Change Control process.

    + Develop and implement policy and procedures for site Change Control within corporate and regulatory standards. Conduct gap assessments as needed for changing corporate and regulatory guidance.

    + Maintain site change control process, ensuring compliance to global procedure and continuously improve the process to support site.

    + Participate in TrackWise Digital Change Control process and enhancements

    + Maintain process for using TWD tool for change control.

    + Coordinate and lead cross-functional meeting with multiple departments to review change assessments and plans (Change Control Board).

    + Collect change review request for the Change Control Board.

    + Prioritize and generate agenda and communication for Change Control Board.

    + Ensure change notice and presentation conform to the procedure, review with change owners, prior to Change Control Board.

    + Assess and approve change notifications to evaluate if proposal satisfies company standards. Ensure change proposals have comprehensive rationale, impact assessment, implementation plans and follow up actions documented. Ensure all approved actions are implemented as per commitment.

    + Provide advice and mentorship to cross-functional teams to enable successful and compliant change controls. Support teams in conducting impact assessments for the change.

    + Work closely with risk management documentation to ensure proper change assessments.

    + Approve the Change Record in the Trackwise Digital Tool

    + Close the Change Record in the Trackwise Digital tool with the Change Summary has been completed and approved.

    + Present business critical and regulatory impactful change controls and metrics to senior leadership.

    + Use TrackWise digital reports and dashboards to monitor change records

    + Develop, implement, and monitor metrics for site change control and report regularly to leadership

    + Maintain change control log, ensuring system risks are documented in both the change notice and change log

    + Prepare annual change control log for review and approval

    + Analyze and document cumulative change review quarterly with molecular and data science teams

    + Train site employees on change control process.

    + Fulfill role as audit subject matter expert for change management during audits.

    + Support internal and external audits and compliance assessments.

    + Maintain a close relationship with Design and Development and Manufacturing teams and an understanding of ongoing projects, including liaising with the Project Review Board.

    Training and Education

    1. Required Bachelors Degree in a Science or Engineering discipline. Minimum ten years professional experience in a Quality Assurance, Quality Control, laboratory or life science or other manufacturing setting that has a formal quality system may be considered in lieu of a degree.

    2. Understanding of good manufacturing practices, ISO 9001, ISO 13485, and/or 21 CFR 820 is required

    3. ASQ Certification or equivalent (e.g., Certified Six Sigma Black Belt, CQE) required.

    Experience

    + 5+ year of experience in an Engineering, Scientific or Investigative role is required.

    + Experience in Quality Assurance, Quality Control, laboratory or life science or other manufacturing setting that has a formal quality system is required.

    + Application and use of Continuous Improvement and QA tools (Pareto, flow charts, Ishikawa, process capability, histogram, 8D, etc.) required.

    + Experience guiding and/or mentoring team is preferred.

    Knowledge, Skills, and Abilities

    + Fundamental understanding of problem investigations (identification, scope determination, impact assessment, and remedial action)

    + Technical writing skills

    + Designing and writing procedures, flowcharting

    + Ability to collaborate cross-functionally

    + Application of Quality Risk Management principles

    + Attention to detail (e.g. document reviews, investigation write ups).

    + High level of written and verbal communications skills

    + 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

    + Developing and reporting Trends and Measures

    + Advanced Project management/leadership skills

    + Creating and giving training presentations

    + Mentoring peers and leading groups

  • Knewin

    Engineer III

    2 weeks ago

    Knewin Salt Lake City, United States

    By joining a team of more than 11,000 people working across more than 60 countries, you will be partof an agile network of talented and ambitious people. In fact, we count on you to engage, connectand collaborate with colleagues all over the world. Seize the opportunity to learn, ...

  • Salt Lake County

    Engineer III

    5 days ago

    Salt Lake County Salt Lake City, United States

    Job Description: · JOB SUMMARY As Engineer, serves as project engineer on engineering design and construction projects, and · independently evaluates, selects and applies standard engineering techniques, procedures and · criteria in making engineering designs and decisions. Th ...

  • Salt Lake County

    Engineer III

    2 weeks ago

    Salt Lake County Salt Lake City, United States

    Job Description · JOB SUMMARY · As Engineer, serves as project engineer on engineering design and construction projects, andindependently evaluates, selects and applies standard engineering techniques, procedures andcriteria in making engineering designs and decisions. This is a ...

  • Salt Lake County

    Engineer III

    2 weeks ago

    Salt Lake County Salt Lake City, United States

    Job Description · JOB SUMMARY · As Engineer, serves as project engineer on engineering design and construction projects, andindependently evaluates, selects and applies standard engineering techniques, procedures andcriteria in making engineering designs and decisions. This is a ...

  • Salt Lake County

    Engineer III

    2 weeks ago

    Salt Lake County Salt Lake City, United States

    Job Description · JOB SUMMARY · As Engineer, serves as project engineer on engineering design and construction projects, andindependently evaluates, selects and applies standard engineering techniques, procedures andcriteria in making engineering designs and decisions. This is a ...

  • bioMérieux SA

    Quality Engineer III

    1 week ago

    bioMérieux SA Salt Lake City, United States

    Position Summary · This is a full-time exempt position. The Quality Engineer III is responsible for assisting with the maintenance of technical aspects of the Quality Management System, specifically the control of Design and Development Changes. This person will be working with ...

  • ICU Medical

    Quality Engineer III

    1 week ago

    ICU Medical Salt Lake City, United States

    · Position Summary · Provide oversight and support of Quality Engineering Sustaining, Metrology operations including design and/or review, development, implementation, and maintenance of measurement programs, ensuring that all cGMP requirements are satisfied. Support validation ...

  • bioMerieux SA Career Site - MULTI-LINGUAL

    Quality Engineer III

    1 week ago

    bioMerieux SA Career Site - MULTI-LINGUAL Salt Lake City, United States

    Description · Position Summary This is a full-time exempt position. The Quality Engineer III is responsible for assisting with the maintenance of technical aspects of the Quality Management System, specifically the control of Design and Development Changes. This person will be w ...

  • ICU Medical

    Quality Engineer III

    1 week ago

    ICU Medical Salt Lake City, United States Full time

    Position Summary · Provide oversight and support of Quality Engineering Sustaining, Metrology operations including design and/or review, development, implementation, and maintenance of measurement programs, ensuring that all cGMP requirements are satisfied. Support validation and ...

  • Dennis Group Salt Lake City

    Mechanical Engineer III

    6 days ago

    Dennis Group Salt Lake City Salt Lake City, United States

    Job Description · Job DescriptionJob Summary · Dennis Group's Mechanical Engineers design and implement mechanical systems as part of a broad engineering and architectural team in designing and building food and beverage production facilities. Specifically, HVAC, plumbing / utili ...

  • University of Utah Health

    Data Warehouse Engineer III

    1 week ago

    University of Utah Health Salt Lake City, United States

    Overview · Local, Hybrid position. Need to live in area or be willing to relocate. · As a patient-focused organization, University of Utah Health exists to enhance the health and well-being of people through patient care, research and education. Success in this mission requires ...

  • AECOM

    Dams & Mining Engineer III

    1 week ago

    AECOM Salt Lake City, United States

    **Company Description** · **How will you make your mark?** · At AECOM, our work in providing access to clean water enables communities to thrive and ecosystems to flourish, contributing to a resilient future. As a global leader in infrastructure consulting, we are at the forefr ...

  • bioMérieux SA

    Engineering Project Manager III/IV

    1 week ago

    bioMérieux SA Salt Lake City, United States

    We are looking for an Engineering Project Manager to join our team. The Engineering Project Manager will work with a team of engineers to accomplish the engineering deliverables for a project. As required, they will also coordinate with individuals from other functional teams (Pr ...

  • Glacier Bancorp

    Corporate Voice Network Engineer III

    4 days ago

    Glacier Bancorp Salt Lake City, United States

    Glacier Bancorp, Inc. (GBCI) is a regional bank holding company providing commercial banking services in 80 communities through 129 banking offices in Montana, Idaho, Colorado, Utah, Washington and Wyoming. GBCI offers an extensive benefits package that includes, but is not limit ...

  • Northwind Group

    Project Controls Engineer III NWG

    1 week ago

    Northwind Group Salt Lake City, United States

    Location: Knoxville, Tennessee · Title: Project Controls Engineer III · Schedule (FT/PT): Regular Full Time · Travel Required: Yes (0-25%) · Clearance: Ability to Obtain · For over 25 years, North Wind Group (North Wind) and its subsidiary companies have been influencing the ...

  • bioMérieux SA

    Quality Engineer II/III-Instrument QA

    18 hours ago

    bioMérieux SA Salt Lake City, United States

    Essential Job Duties and Responsibilities: · Perform all work in compliance with company policy and within the guidelines of its Quality System. · Lead investigations into product and material non-conformances (NCR), including problem identification, product & process quality ris ...

  • FLSmidth & Co. A/S

    Engineer III

    1 week ago

    FLSmidth & Co. A/S Midvale, United States

    By joining a team of more than 11,000 people working across more than 60 countries, you will be part of an agile network of talented and ambitious people. In fact, we count on you to engage, connect and collaborate with colleagues all over the world. Seize the opportunity to lear ...

  • Merit Medical Systems

    Engineer III

    1 week ago

    Merit Medical Systems South Jordan, United States

    Engineer III - South Jordan, UT page is loaded · Engineer III - South Jordan, UT · Apply · locations · South Jordan, UT · time type · Full time · posted on · Posted 3 Days Ago · job requisition id · JR104535 · Why Merit? · At Merit Medical, our mission is to create inn ...

  • Flowers Baking Co of Utah, LLC

    Maintenance Engineer III

    6 days ago

    Flowers Baking Co of Utah, LLC West Jordan, United States Regular, Full time

    Why Flowers? · Flowers Foods, Inc. (NYSE: FLO) is one of the largest producers of packaged bakery foods in the United States with 2022 sales of $4.8 billion. Among the company's top brands are Nature's Own, Dave's Killer Bread, Wonder, Canyon Bakehouse, and Tastykake. Learn more ...

  • Merit Medical Systems, Inc.

    OEM Engineer III

    1 week ago

    Merit Medical Systems, Inc. South Jordan, United States

    Why Merit? · At Merit Medical, our mission is to create innovative medical devices that improve lives. Our goal is to hire and develop people who want to build something special through hard work, team effort, and commitment. Together, we are making a difference in the lives of p ...