Staff Quality Engineer

Thermo Fisher Scientific•Logan, UT

1d•Onsite

About The Position

When you’re a part of the team at Thermo Fisher Scientific, you’ll do important work, like helping customers in finding cures for cancer, protecting the environment or making sure our food is safe. Your work will have real-world impact, and you’ll be supported in achieving your career goals. Location/Division Specific Information Logan, Utah—Single Use Technologies How will you make an impact? As a Staff Quality Engineer, you will directly interact with customer teams, which include Quality, Procurement, and senior leadership personnel. Likewise, you’ll directly partner with internal teams to support Quality investigations, Engineering and Production improvement initiatives, and Quality System improvements. The Staff QE is also a coach and mentor to the Quality Engineering team, leading by example through your integrity, intensity, innovation, and involvement.

Requirements

Minimum Required: Bachelor’s degree (preferably in a STEM field), ASQ Certified Quality Engineer (CQE) required, or able to obtain within one year from hire date; other ASQ certifications may be considered in lieu of CQE (e.g., CRE, CMQ/OE, CSSBB, CMDA).
5+ years of experience in a Quality Engineering role.
5+ years of experience in medical device, pharmaceutical, or biotech industry in Engineering, Quality, or Regulatory roles.
Direct experience working within ISO 13485 and 21 CFR 820 QMS frameworks, including ISO 14971 risk management standards.
Excellent professional writing and communication skills; ability to effectively communicate with senior and executive level leaders, customers, and internal Production and Engineering teams.
Maintaining compliance for a Quality Management System (QMS)
Advanced knowledge and direct experience facilitating Root Cause Analysis (RCA) tools and methodologies with cross-functional teams.
Nonconformance (product/process) investigation, resolution, and reporting.
Deviation and containment management.
CAPA planning, execution, and documentation.
Effectiveness monitoring planning, analysis, and documentation.
Sample size determination, statistical analysis (hypothesis testing), metric trending planning, data collection planning, data analysis, data trending, data visualization, and data reporting working within data governance processes.
Systems verification and validation (e.g., utility, facility, equipment, process, test method, software).
Design control/design and development processes.
Project management, task organization, and assignment prioritization.
Product sterilization methods and processes (e.g., gamma sterilization).
Complaint handling, failure investigation, and reporting.
Risk management (e.g., FMEA, risk analysis, risk evaluation, benefit-risk analysis).
Statistical Process Control (SPC).
Supplier quality management.
Quality auditing.
Change management.
Documentation control and good documentation practices.
Measurement system analysis (MSA).
Business software: Excel, Word.
QMS Software: TrackWise.
Specialized software: Minitab, PowerBI.

Nice To Haves

Experience directly interacting and communicating with senior and executive leadership personnel, customer investigation teams, and customer leadership teams preferred.

Responsibilities

Coach and mentor Quality Engineering and Quality personnel.
Participate as a core member in an Autonomous Manufacturing Group (AMG).
Participate and lead activities related to improving and maintaining Quality Systems.
Participate and lead Risk Management activities, including developing, maintaining, assessing and evaluation product/process risk profiles.
Lead product and process investigations using advanced root cause tools and methods.
Develop, execute, and monitor CAPA plans, including planning for and objectively demonstrating CAPA effectiveness.
Perform data trending and reporting for Quality initiatives, site QMS performance monitoring, and specific projects, as needed.
Complaint handling, including leading investigations, reporting results, and communicating to internal/external stakeholders.
Support QMS audits by providing documents and interacting directly with auditors.
Participate in internal audits as either a lead auditor or supporting auditor.