Quality Engineer III

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, including investigations, validations, corrective actions, risk management, and continuous improvement efforts. 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, Change Control, 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, Education and Experience:

Required - Bachelor's 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. 5+ years of direct experience will be accepted in lieu of degree.

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

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

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

Please be aware that recruitment related scams are on the rise. Fraudulent job postings are being placed on other websites, and individuals posing as bioMrieux Talent Acquisition team members are reaching out via email or text message in an attempt to collect your personal and confidential information. In some cases, these scammers are also conducting bogus interviews prior to extending fraudulent offers of employment. Beware of individuals reaching out using general phone numbers and non-bioMerieux email domains (i.e. Hotmail.com, Gmail.com, Yahoo.com, etc.). If you are concerned that an interview experience or offer of employment might be a scam, please make sure you are searching for the posting on our careers site https://careers.biomerieux.com/ or contact us at [email protected].

BioMrieux Inc. and its affiliates are Equal Opportunity/Affirmative Action Employers. 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 BioMrieux's or its affiliates' application process by contacting us via telephone at (385) 770-1132, by email at [email protected], or by dialing 711 for access to Telecommunications Relay Services (TRS).