Overview
Quality Engineer II Jobs in Mahwah, NJ at Mindray North America
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
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Title: Quality Engineer II
Company: Mindray North America
Location: Mahwah, NJ
