Senior Quality Assurance Engineer

2 weeks ago

Salt Lake, Utah, United States bioMerieux Inc. Full time


Senior Quality Assurance Engineer - Hybrid

Location: Salt Lake City, UT, United States

Position Type: Unfixed Term

Job Function: Quality

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bioMerieux Inc. stands as a global frontrunner in the domain of in vitro diagnostics, delivering innovative solutions that pinpoint the origins of diseases and contamination, thereby enhancing patient care and ensuring consumer safety.

With a robust workforce exceeding 6,200 across multiple locations, including a prominent site in Salt Lake City, we invite you to become part of a family-owned enterprise that prioritizes a long-term vision and a people-centric culture.

Position Overview

This full-time exempt role entails the responsibilities of a Senior Quality Assurance Engineer, focusing on the upkeep of the technical components of the Quality Management System, particularly in managing Design and Development Changes. The individual will collaborate closely with various teams beyond Quality Assurance, necessitating a customer-oriented mindset. This role serves as a key advisor on intricate technical and procedural matters.

Key Responsibilities

  • Ensure compliance with company policies and the established Quality System.
  • Execute the responsibilities of a Quality Engineer II autonomously.
  • Oversee the Non-Conformance Reports (NCR), Corrective and Preventive Actions (CAPA), validation, and risk management frameworks to guarantee:
  • Adherence to relevant procedures and requirements.
  • Timely execution of tasks.
  • Lead and mentor teams in investigation methodologies and validation strategies.
  • Document discussions, track action items, and communicate with senior management as necessary.
  • Manage large-scale or intricate projects as assigned.
  • Analyze and report on Quality-related metrics.
  • Provide guidance to junior Quality Engineering personnel.
  • Enhance efficiency and uniformity through ongoing improvements in the Change Control process.
  • Formulate and implement policies and procedures for site Change Control, aligning with corporate and regulatory standards.
  • Conduct assessments to identify gaps in compliance with evolving corporate and regulatory guidelines.
  • Maintain the site change control process, ensuring adherence to global procedures while continuously refining the process.
  • Engage in the TrackWise Digital Change Control process and its enhancements.
  • Facilitate and lead cross-departmental meetings to evaluate change assessments and strategies (Change Control Board).
  • Collect and prioritize change review requests for the Change Control Board.
  • Ensure change notifications and presentations comply with established procedures, reviewing with change owners prior to board meetings.
  • Evaluate and approve change notifications to confirm compliance with company standards, ensuring comprehensive documentation of rationale, impact assessments, and implementation plans.
  • Advise and mentor cross-functional teams to ensure successful and compliant change controls.
  • Collaborate closely with risk management documentation to guarantee accurate change assessments.
  • Approve and finalize Change Records in the TrackWise Digital Tool.
  • Conclude Change Records with completed and approved Change Summaries.
  • Present critical business and regulatory change controls and metrics to senior leadership.
  • Utilize TrackWise digital reports and dashboards to monitor change records.
  • Develop, implement, and track metrics for site change control, providing regular updates to leadership.
  • Maintain a change control log, ensuring that system risks are documented in both change notices and logs.
  • Prepare an annual change control log for review and approval.
  • Analyze and document cumulative change reviews quarterly with relevant teams.
  • Conduct training for site personnel on the change control process.
  • Serve as an audit subject matter expert for change management during audits.
  • Support internal and external audits and compliance evaluations.
  • Maintain strong relationships with Design, Development, and Manufacturing teams, staying informed about ongoing projects.

Qualifications

  1. Bachelor's Degree in a Science or Engineering discipline is required. A minimum of ten years of professional experience in Quality Assurance, Quality Control, laboratory, or manufacturing settings with a formal quality system may be considered in lieu of a degree.
  2. In-depth knowledge of good manufacturing practices, ISO 9001, ISO 13485, and/or 21 CFR 820 is essential.
  3. ASQ Certification or equivalent (e.g., Certified Six Sigma Black Belt, CQE) is required.

Experience

  • Minimum of 5 years in an Engineering, Scientific, or Investigative role is required.
  • Experience in Quality Assurance, Quality Control, laboratory, or manufacturing settings with a formal quality system is necessary.
  • Proficiency in Continuous Improvement and QA tools (e.g., Pareto, flow charts, Ishikawa, process capability, histogram, 8D) is required.
  • Experience in guiding and mentoring teams is preferred.

Skills and Competencies

  1. Solid understanding of problem investigation processes (identification, scope determination, impact assessment, and remedial action).
  2. Strong technical writing abilities.
  3. Capability in designing and drafting procedures and flowcharts.
  4. Ability to collaborate effectively across functions.
  5. Application of Quality Risk Management principles.
  6. Meticulous attention to detail (e.g., document reviews, investigation reports).
  7. Excellent written and verbal communication skills.
  8. Ability to engage with Statisticians and perform statistical calculations as needed.
  9. Wisdom to seek assistance when necessary.
  10. Proficiency in MS Office tools, including Outlook, Word, and Excel.
  11. Experience in developing and reporting Trends and Measures.
  12. Advanced project management and leadership capabilities.
  13. Experience in creating and delivering training presentations.
  14. Ability to mentor peers and lead teams.

Schedule: This is a Hybrid work schedule in Salt Lake City, UT

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