R&D Quality Technician I
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
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
- 1-3 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.
- 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.
- 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.
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
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