Quality Engineer II

Job Summary

• Designs, implements, and maintains quality assurance protocols and methods for processing materials into partially finished or finished products. Responsible for planning, implementing, and managing compliance of manufacturing and production processes with internal and external safety, quality, and regulatory standards for worldwide distribution.
• Designs methods and procedures for inspecting, testing, and evaluating the precision and accuracy of production processes, production equipment, and finished products. Performs analysis of reports and production data to identify trends and recommend updates or changes to quality standards and procedures.
• Ensures compliance with in-house and external specifications and standards (GLP, GMP, ISO, Six Sigma). Works on problems of moderate scope requiring analysis of multiple factors. Exercises judgment within defined procedures and builds productive internal and external relationships. Applies company policies to resolve issues and receives general instructions on routine work and detailed instructions on new assignments.

Essential Duties And Responsibilities

• Write and execute TMVs and simple change orders (procedure updates, clarifications, no validations required)
• Support moderate to complex change orders (validations, risk analysis updates, SOP/document creation or major revisions)
• Write and execute PQs
• Lead and own CAPAs
• Support HRAs/HHEs
• Provide quality engineering support to Operations, Engineering, and R&D to ensure robust product builds and manufacturing practices
• Ensure products meet regulatory and quality standards and customer expectations
• Develop and implement procedures, inspection methods, and test methods in compliance with QMS, Medical Device QSR, and MDD requirements
• Provide training as required
• Identify and resolve quality issues with urgency
• Perform risk assessments and update risk management documentation
• Conduct customer complaint investigations, root cause analysis, and corrective actions
• Investigate and process Quality System Investigations (QSI) and Non-Conforming Events (NCE)
• Prepare reports evaluating effectiveness of quality systems
• Participate in MRB, NCE, CAPA, and SCAR processes
• Review and approve ECOs, change orders, engineering studies, specifications, drawings, and validation documentation
• Participate in facility and supplier audits, Notified Body audits, and FDA inspections
• Promote quality system standards and best practices, focusing on defect prevention, variation reduction, and continuous improvement

Physical Demands

• Sitting; using hands to handle objects, tools, or controls
• Standing, walking, reaching, stooping, kneeling, crouching, or crawling
• Lifting/moving up to 40 pounds
• Exposure to mechanical parts, vibration, and moderate noise
• Exposure to hazardous chemicals or materials
• Safety shoes required in designated areas
• Exposure to high voltage electronics and radiation
• Ability to work in clean room, controlled, or dark room environments

Qualifications

Education:

• Bachelor’s Degree (Technical/Engineering preferred)

Experience

• 1–2 years with Bachelor’s degree OR 0–2 years with Master’s degree
• Experience in FDA regulated industry preferred

Skills

• Strong computer skills (word processing, spreadsheets, databases)
• Ability to read, analyze, and interpret technical documents and regulations
• Strong technical writing skills (reports, procedures)
• Good presentation and interpersonal skills
• Knowledge of GMP and GDP principles
• Understanding of 21 CFR 820, ISO 13485, and MDD requirements
• Knowledge of microbiology, molecular biology, biochemistry, or related fields
• Understanding of nucleic acid amplification and detection technologies
• Knowledge of scientific method and statistical analysis
• Familiarity with Oracle and Agile systems
• Certified Quality Engineer (preferred)