R&D Quality Technician I

R&D Quality Technician I

The R&D Quality Technician I supports the Research & Development and Quality teams by ensuring quality requirements are integrated throughout the product development lifecycle and successfully transitioned into manufacturing. This position plays a critical role in developing production-ready inspection methods, performing advanced metrology inspections, supporting engineering builds, reviewing quality documentation, and driving continuous improvement through data analysis and quality system activities.

Working closely with Engineering, Quality, Manufacturing, and Operations, the R&D Quality Technician I helps ensure new products meet customer, regulatory, and Aptyx quality requirements while supporting product development, validation, and commercialization activities.

Essential Duties & Responsibilities

Quality Management System

• Follow the Aptyx Quality Management System (QMS), including all applicable Standard Operating Procedures (SOPs), work instructions, and regulatory requirements.
• Ensure compliance with ISO 13485, FDA Quality System Regulation (21 CFR Part 820), Good Documentation Practices (GDP), and internal quality standards.
• Maintain accurate, complete, and timely documentation in accordance with Good Documentation Practices.

Quality Documentation & Record Review

• Review Device History Records (DHRs), incoming inspection reports, First Article Inspections (FAIs), and other quality documentation to verify product conformity.
• Verify inspection results meet engineering specifications and customer requirements.
• Identify documentation discrepancies and coordinate corrective actions with appropriate departments.

Quality Systems Support

• Support the timely execution of Quality Management System activities, including:
  • Nonconformance Reports (NCRs)
  • Corrective and Preventive Actions (CAPAs)
  • Deviations
  • Investigation activities
  • Root cause analysis
• Track quality activities and collaborate with cross-functional teams to ensure timely completion.
• Lead assigned quality system activities as directed by management.

Metrology & Inspection

• Perform dimensional inspections utilizing:
  • Coordinate Measuring Machines (CMM)
  • Vision Measurement Systems
  • Optical comparators
  • Digital measuring equipment
  • Precision hand inspection tools
• Develop and optimize inspection methods for new product introductions.
• Validate inspection methods to ensure repeatability and reproducibility.
• Assist in establishing production-ready inspection processes.

R&D and Engineering Support

• Support prototype and engineering builds by:
  • Performing line clearance audits
  • Conducting in-process and final inspections
  • Providing inspection guidance during builds
  • Communicating quality concerns to Engineering and Manufacturing
• Perform engineering testing supporting:
  • Design Verification
  • Process Validation (IQ/OQ/PQ)
  • Proof of Concept testing
  • Lot Release testing
• Assist engineering teams with troubleshooting product and process issues.

Data Collection & Continuous Improvement

• Collect and analyze quality data from inspections and quality records.
• Develop reports and trending metrics to monitor:
  • Process capability
  • Defect trends
  • Yield
  • Inspection performance
  • Quality system effectiveness
• Utilize statistical tools to identify improvement opportunities.
• Support continuous improvement initiatives to improve product quality and inspection efficiency.

Training & Technical Support

• Serve as a technical resource for Quality Inspectors.
• Develop inspection procedures, visual aids, and work instructions.
• Train Quality Inspectors on new inspection methods, engineering requirements, and quality expectations.
• Provide coaching to improve consistency and inspection accuracy.

Cross-Functional Collaboration

• Partner closely with:
  • R&D Engineering
  • Manufacturing Engineering
  • Production
  • Quality Engineering
  • Operations
• Participate in design reviews, risk assessments, and new product transfer activities.
• Support successful transition of new products into production.

Qualifications

Education

• Associate degree in Mechanical Engineering Technology, Biomedical Engineering Technology, Manufacturing Technology, Materials Science, Physics, or related technical discipline required.
• Bachelor's degree is preferred.

Experience

• 13 years of experience in a manufacturing, engineering, quality, or laboratory environment.
• Experience within the medical device industry or another regulated manufacturing environment preferred.
• Experience supporting new product development or manufacturing transfers is a plus.

Technical Knowledge

• Knowledge of quality inspection methods and measurement techniques.
• Experience using metrology equipment including CMMs, vision systems, and precision measuring instruments.
• Ability to interpret:
  • Engineering drawings
  • GD&T
  • Specifications
  • Inspection plans
• Working knowledge of Microsoft Office applications.
• Experience with statistical software such as Minitab preferred.
• Familiarity with CAD software and ERP/QMS systems is beneficial.

Competencies

• Strong attention to detail and commitment to quality.
• Excellent analytical and problem-solving skills.
• Effective verbal and written communication skills.
• Ability to prioritize multiple assignments in a fast-paced environment.
• Strong organizational and documentation skills.
• Ability to work independently while collaborating effectively within cross-functional teams.
• Continuous improvement mindset with a passion for learning and process optimization.

Physical Requirements

• Ability to sit or stand for extended periods.
• Frequently perform repetitive hand movements while using measuring equipment.
• Ability to lift up to 25 pounds occasionally.
• Manual dexterity required for handling small precision components.
• Ability to work within laboratory, manufacturing, and cleanroom environments while wearing required PPE.

Acknowledgement

I have received a copy of this job description, have read and understood it, and will complete all assigned duties and responsibilities. I recognize that the company reserves the right to modify this job description and that I will be informed of any and all modifications prior to their effective date.

Employee Signature - Date