Quality Technician

Job Title:

Quality Technician

Job Description

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…