QUALITY ENGINEER II

LOCATION: Draper, UT

SCHEDULE: Standard

DURATION: 9-Month Contract

MAX PAY RATE: $37-42/hr.

Job Responsibilities

In this role, you will support quality assurance and manufacturing quality activities within a regulated medical device environment. Key responsibilities include:

· Supporting equipment, process, and test method validation activities, including IQ, OQ, PQ, and TMV.

· Conducting root cause investigations and supporting nonconformance and CAPA activities.

· Ensuring products and processes comply with applicable FDA, ISO 13485, GMP, and internal Quality Management System requirements.

· Supporting manufacturing, engineering, supplier quality, regulatory, operations, and quality teams in resolving quality issues.

· Analyzing quality and manufacturing data to identify trends, recurring defects, and opportunities for improvement.

· Supporting continuous improvement initiatives focused on process capability, defect reduction, compliance, and operational excellence.

Essential Duties and Job Functions

· 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 accordance with FDA, ISO 13485, GMP, and internal quality requirements.

· Investigate product and process nonconformances and perform root cause analysis using methodologies such as 5 Why, Fishbone, Fault Tree Analysis, and other quality tools.

· Author, review, and maintain NCR, CAPA, deviation, validation, and technical documentation.

· Facilitate CAPA investigations, identify corrective and preventive actions, and verify the 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 process improvement opportunities.

· 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 Management 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.

Knowledge & Skills

· Hands-on experience executing and documenting IQ, OQ, PQ, and TMV activities.

· Strong knowledge of FDA 21 CFR Part 820, ISO 13485, GMP, and medical device quality system requirements.

· Experience conducting and documenting root cause investigations and implementing effective CAPAs.

· Working knowledge of NCR, CAPA, change control, deviation, and risk management processes.

· Understanding of validation lifecycle management, including 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 structured problem-solving methodologies.

· Proficiency in reviewing technical drawings, specifications, procedures, and validation documentation.

· Strong technical writing and documentation skills.

· Excellent verbal and written communication skills.

· Strong organizational skills with the ability to manage multiple priorities and projects.

· Detail-oriented with a strong commitment to compliance and product quality.

· Ability to independently manage investigations, validations, projects, and quality system activities.

· Ability to build productive working relationships across Manufacturing, Engineering, Quality, Regulatory Affairs, and Operations.

· Strong teamwork, problem-solving, analytical, and critical-thinking skills.

Education & Experience

· Bachelor's degree in Engineering required.

· 2–4 years of relevant quality engineering experience required.

· Experience in a regulated medical device manufacturing environment preferred.

· Experience with equipment, process, and test method validation preferred.

· Experience with CAPA, NCR, nonconformance investigations, risk management, and change control preferred.

· Familiarity with FDA, ISO 13485, GMP, and Quality Management System requirements preferred.

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