Quality Technician

Quality Technician

The Quality Technician performs in-process and final inspection of internally produced components and assemblies for an implantable mitral valve system that is currently in an FDA pivotal clinical trial. This role plays a critical part in maintaining the integrity of the Quality Management System (QMS) in accordance with 21 CFR Part 820, ISO 13485:2016, and applicable international standards. The Quality Technician evaluates valve frame subassemblies, sewn textile and biological tissue components, and the associated catheter-based delivery system to ensure each unit meets established acceptance criteria before progressing through manufacturing or being released for clinical use.

Responsibilities

• Perform dimensional, visual, and functional inspection of nitinol or metal valve frames, sewn tissue leaflets, fabric cuffs, and suture assemblies using calibrated measurement equipment, optical comparators, and microscopy as required.
• Execute final device inspection and release activities for finished valve assemblies intended for clinical trial use, ensuring all acceptance criteria are met.
• Inspect catheter-based delivery system subassemblies, including handle mechanisms, shaft components, and deployment interfaces, at defined in-process checkpoints to verify conformance.
• Complete inspection records, device history record (DHR) signoffs, and nonconformance reports (NCRs) accurately and on time.
• Identify, segregate, tag, and document nonconforming products in accordance with established nonconforming material procedures, initiating NCR workflows and providing objective evidence to support disposition decisions.
• Participate as a technical contributor in root cause investigations and support corrective and preventive action (CAPA) activities by providing inspection data and trend analysis.
• Create and maintain accurate, complete, and legible inspection records in accordance with Good Documentation Practice (GDP).
• Author and revise inspection work instructions, acceptance criteria documentation, and inspection plans in collaboration with Manufacturing Engineering and Quality Engineering.
• Identify out-of-tolerance instruments and initiate calibration requests in compliance with the calibration program.
• Verify that all measurement tools used for regulated inspection activities are within calibration status prior to use.
• Handle sterile and delicate components in alignment with cleanroom protocols and contamination control practices when required.
• Work independently to prioritize competing inspection holds and escalate issues appropriately when decisions exceed defined authority.
• Collaborate effectively with manufacturing personnel and quality management to communicate inspection results, nonconformances, and quality trends.
• Contribute to continuous improvement initiatives by applying strong problem-solving skills to enhance inspection processes and product quality.

Essential Skills

• Minimum 3–5 years of quality technician experience in a regulated medical device manufacturing environment operating under 21 CFR Part 820 and/or ISO 13485.
• Demonstrated experience inspecting complex, precision-assembled products, with experience in implantable, sterile, or Class III devices strongly preferred.
• Hands-on experience inspecting sewn, textile, or biological tissue components or similar delicate assemblies requiring fine-tolerance visual and dimensional inspection.
• Working knowledge of 21 CFR Part 820 Quality System Regulation and ISO 13485:2016 requirements as they apply to inspection, nonconformance management, and records control.
• Familiarity with GD&T (Geometric Dimensioning and Tolerancing) principles and strong ability to interpret engineering drawings.
• Understanding of CAPA, NCR, and deviation or concession processes within a regulated QMS.
• Proficiency with calibrated inspection tools, including calipers, micrometers, and stereo microscopy, as well as an understanding of coordinate measuring principles.
• Proven ability to maintain strict attention to detail and uphold inspection integrity under production schedule pressure.
• Effective written and verbal communication skills to document nonconformances, interface with manufacturing personnel, and present inspection data to quality management.
• Demonstrated ability to work independently, manage priorities, and escalate issues when necessary within defined authority limits.
• Proficiency with electronic QMS (eQMS) platforms and Microsoft Office applications.
• Ability to work in a regulated cleanroom or controlled environment as required by device manufacturing protocols.
• Strong problem-solving abilities and a continuous improvement mindset.

Additional Skills & Qualifications

• GED, high school diploma, or equivalent education preferred.
• ASQ Certified Quality Inspector (CQI) or Certified Quality Technician (CQT) certification preferred.
• ASQ Certified Quality Auditor (CQA) certification is a plus.
• Knowledge of sterile device handling, cleanroom protocols, and contamination control practices.
• Prior…