Quality Engineer

Quality Engineer at Nesco Resource Quality Engineer at Nesco Resource in Tempe, Arizona Posted in about 21 hours ago.

Type:

full-time

Job Description:

Quality Engineer Greater Phoenix Area Full Time | Onsite $110,000 Base Salary We are partnering with a growing manufacturer in the Greater Phoenix area seeking a Quality Engineer to support product quality, manufacturing readiness, and production transfer initiatives across the full product lifecycle. This role will work closely with Engineering, Manufacturing, Supplier Quality, and Regulatory teams to ensure products and processes meet quality and compliance standards while supporting manufacturing operations and continuous improvement efforts. Responsibilities Support quality activities across product development, validation, and production transfer Develop and maintain product and process risk management documentation Author and review

IQ/OQ/PQ

protocols, reports, and validation documentation Support supplier qualification activities and outsourced process validation Collaborate on process improvements related to quality, yield, throughput, and efficiency Review drawings, specifications, manufacturing records, and test methods to ensure production readiness Investigate non-conformances, perform root cause analysis, and support CAPA activities Create and maintain 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 FMEA, MSA, and process capability analysis 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 Experience supporting process validation and manufacturing transfer activities Working knowledge of

FDA/QMSR, ISO 13485, ISO

14971, and related quality standards Strong experience with validation documentation, risk management, and quality systems Excellent communication and documentation skills ASQ Certified Quality Engineer preferred Additional Details Monday through Friday schedule Occasional travel may be required Strong preference for candidates with Class II medical device experience