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Quality engineer Ii
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Nesco Resource
Tempe, AZ (In Person)
$110,000 Salary, Full-Time
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Job Description
Overview Join a dynamic and expanding manufacturer in the Greater Phoenix Area as a key player in ensuring product quality and manufacturing excellence. This full-time, onsite position offers a competitive base salary of $110,000. As a quality engineering professional, you will collaborate with cross-functional teams to uphold quality and compliance standards throughout the product lifecycle, from development to production transfer. Responsibilities Support quality assurance activities across product development, validation, and production transfer stages. Develop and maintain comprehensive product and process risk management documentation. Author and review Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols, reports, and validation documentation. Assist in supplier qualification activities and outsourced process validation. Collaborate on process improvements to enhance quality, yield, throughput, and efficiency. Review technical drawings, specifications, manufacturing records, and test methods to ensure production readiness. Investigate non-conformances, conduct root cause analysis, and support Corrective and Preventive Action (CAPA) activities. Create and maintain Standard Operating Procedures (SOPs), work instructions, inspection procedures, and related quality documentation. Support post-market surveillance and regulatory documentation activities. Apply statistical methods and risk-based tools including Failure Modes and Effects Analysis (FMEA), Measurement System Analysis (MSA), and process capability analysis. Required Qualifications Bachelor's degree in Engineering, Biomedical Technology, Biology, Chemistry, Electronics, or related field. 5 years of quality engineering experience within the medical device industry. Proven experience supporting process validation and manufacturing transfer activities. Working knowledge of FDA Quality System Regulation (QSR), ISO 13485, ISO 14971, and related quality standards. Strong experience with validation documentation, risk management, and quality systems. Excellent communication and documentation skills. Preferred Qualifications ASQ Certified Quality Engineer certification. Experience with Class II medical devices.