Quality Engineer II

Job Title: Quality Engineer II
Location: Draper, UT
Duration: 09 Months

Job Summary:
The Quality Engineer II is responsible for supporting quality assurance and manufacturing quality activities in a regulated medical device environment. This role provides technical expertise in process and equipment validation, root cause investigations, nonconformance management, CAPA implementation, and continuous improvement initiatives. The Quality Engineer II partners with cross-functional teams to ensure products and processes comply with applicable regulatory requirements, including FDA 21 CFR Part 820, ISO 13485, and internal Quality Management System (QMS) requirements.

The ideal candidate possesses hands-on experience executing and documenting Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), and Test Method Validation (TMV) activities, as well as conducting investigations and implementing effective corrective and preventive actions to improve product quality and process performance

Job Responsibilities:
" Lead and support equipment, process, and test method validation activities, including development, execution, and approval of IQ, OQ, PQ, and TMV protocols and reports.
" Ensure validation activities are performed in compliance with FDA, ISO 13485, GMP, and internal quality requirements.
" Investigate product and process nonconformances and perform root cause analysis using structured problem-solving methodologies such as 5 Why, Fishbone, Fault Tree Analysis, and other quality tools.
" Author, review, and maintain Client, CAPA, deviation, validation, and technical documentation.
" Facilitate CAPA investigations, identify corrective and preventive actions, and verify effectiveness of implemented solutions.
" Support manufacturing, engineering, and supplier quality teams in resolving quality issues and reducing recurring defects.
" Participate in risk management activities, including PFMEA reviews, risk assessments, and implementation of risk mitigation strategies.
" Analyze quality and manufacturing data using statistical techniques to identify trends, adverse conditions, and opportunities for improvement.
" Support internal and external audits and regulatory inspections by providing technical documentation and evidence of compliance.
" Review and approve changes through change control processes and assess potential quality impacts to validated systems and processes.
" Develop and revise quality procedures, work instructions, validation plans, and related quality system documentation.
" Drive continuous improvement initiatives focused on process capability, defect reduction, compliance, and operational excellence.
" Provide quality engineering support for new product introductions, manufacturing transfers, and process improvements.

Technical Skills
" Demonstrated hands-on experience executing and documenting IQ, OQ, PQ, and TMV activities.
" Strong knowledge of FDA 21 CFR Part 820, ISO 13485, and medical device quality system requirements.
" Experience conducting & documenting root cause investigations and implementing effective CAPAs.
" Working knowledge of Client, CAPA, change control, deviation, and risk management processes.
" Experience with validation lifecycle management, protocol development, execution, and report generation.
" Working knowledge of statistical analysis tools and quality methodologies, including SPC, Minitab, DOE, Gage R&R, and process capability analysis.
" Experience with PFMEA, risk assessments, and problem-solving methodologies.
" Proficiency in reviewing technical drawings, specifications, procedures, and validation documentation.

Professional Skills
" Strong technical writing and documentation skills.
" Excellent verbal and written communication abilities.
" Ability to work effectively with Manufacturing, Engineering, Regulatory Affairs, Operations, and Quality teams.
" Strong organizational skills with the ability to manage multiple priorities and projects.
" Detail-oriented with a commitment to compliance and product quality.
" Self-motivated and capable of independently managing projects, investigations, validations, and quality system activities while also contributing effectively in a team-oriented environment.
" Proven ability to build strong working relationships across Manufacturing, Engineering, Quality, Regulatory, and Operations functions to achieve shared objective

Education/Experience:
" Bachelor's degree in engineering required.
" 2-4 years experience required

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