Quality Engineer Jobs

About The Position

Requirements

• Bachelor’s degree in Biomedical, Mechanical, Manufacturing, Industrial, Electrical, Chemical, Materials, or Systems Engineering, or a closely related engineering field.
• Typically 2–5 years of quality experience in a regulated industry.
• Hands-on experience applying validation, design controls, risk management, investigations, CAPA, statistical methods, and quality system requirements in manufacturing.
• Working knowledge of applicable medical device quality system requirements, ISO, GMP requirements, and relevant international standards.
• Ability to independently interpret and apply regulatory, quality system, technical, and customer requirements and resolve complex quality issues using structured problem-solving.
• Proficiency in statistical analysis and data interpretation, including practical applications of DOE, FMEA, capability analysis, and sampling methods.
• Strong technical writing, project leadership, organization, and cross-functional communication skills.
• Ability to understand product applications, specifications, functionality, assembly, manufacturing processes, and test methods.
• Microsoft Office skills and ability to quickly learn eQMS, ERP, and other business systems.
• Ability to manage multiple priorities with minimal oversight, adapt to changing business needs, communicate effectively in English, and travel as required.
• Ability to perform the essential duties satisfactorily and function effectively in a fast-paced environment where priorities may change.

Nice To Haves

• Quality Engineer certification or another relevant professional certification.
• Experience in the medical device industry.
• Experience with MasterControl, Oracle, or comparable systems.

Responsibilities

• Develop and execute IQ, OQ, and PQ validation protocols for equipment, processes, and systems, including software.
• Prepare validation reports and analyze and interpret validation data to identify trends, anomalies, and improvement opportunities.
• Ensure validation activities comply with regulatory requirements and organizational and industry standards.
• Represent Quality Engineering on new product development, sustaining engineering, verification and validation, risk management, and design or process change activities, including reviewing and approving applicable technical documentation.
• Lead or provide technical support for investigations involving nonconformances, complaints, CAPAs, and supplier or manufacturing quality issues, including root cause analysis, corrective action development, and effectiveness assessment.
• Apply quality engineering and statistical tools, including DOE, FMEA, capability analysis, sampling plans, and trend analysis, to assess risk and improve products, processes, inspection methods, and control strategies.
• Provide technical supplier quality support for qualification, audits, validations, change assessments, and evaluation of supplier corrective action responses.
• Participate in regulatory, notified body, customer, corporate, and internal audits by providing technical documentation and evidence-based responses within areas of responsibility.
• Partner with R&D, Manufacturing Engineering, Operations, Regulatory, Procurement, and Quality Systems to incorporate and maintain quality requirements throughout the product lifecycle.
• Provide technical guidance to less experienced Quality Associates and support departmental quality and continuous improvement initiatives.
• Follow departmental Standard Operating Procedures, Work Instructions, and applicable safety requirements.

Benefits

• Annual performance bonus may be included in the total compensation package.
• Medical, dental, and vision benefits may be included in the total compensation package.
• 401K match may be included in the total compensation package.