Engineer ll

W-2 Contract

Duration - 9 Months

Location - Draper, UT 84020

Pay - $38 to $43.44/hour

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 NCR, 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

All qualified applicants will receive consideration for employment without regard to race, color, national origin, age, ancestry, religion, sex, sexual orientation, gender identity, gender expression, marital status, disability, medical condition, genetic information, pregnancy, or military or veteran status. We consider all qualified applicants, including those with criminal histories, in a manner consistent with state and local laws, including the California Fair Chance Act, City of Los Angeles' Fair Chance Initiative for Hiring Ordinance, Los Angeles County Fair Chance Ordinance, and San Francisco Fair Chance Ordinance.