Role Overview:Myant is a leading innovator in the field of textile-based technology, leveraging advanced materials and smart fabrics to enhance human health and wellness. With our cutting-edge developments in wearables, we aim to revolutionize how the world approaches personal care and health monitoring. We are looking for a passionate HR Manager to join our team and contribute to building a dynamic, collaborative, and innovative workplace culture.
As a Quality Assurance Inspector, you will provide hands-on quality support to production and manufacturing operations within a regulated medical device environment. Working closely with the Senior Quality Assurance Specialist, Manufacturing, and Engineering teams, you will perform inspection, testing, and production quality activities to ensure that products and processes meet established specifications, quality standards, and regulatory requirements.
This is an execution-focused role that directly supports product quality, patient safety, and compliance with ISO 13485, MDSAP, EU MDR, and FDA QMSR expectations at the manufacturing site level.
Key Responsibilities:
- Perform incoming, in-process, and final inspections of medical device components, sub-assemblies, and finished products in accordance with approved procedures, work instructions, and acceptance criteria
- Conduct visual and dimensional inspections of raw materials, purchased components, and supplier-provided goods against approved specifications and drawings
- Support receiving inspection activities, including verification of certificates of conformance (CoCs), certificates of analysis (CoAs), and supplier documentation against purchase order requirements
- Provide quality support on the manufacturing floor, including first article inspections, lot sampling, in-process checks, and line clearance verifications
- Operate and maintain inspection and measurement equipment, including calipers, micrometers, gauges, optical comparators, and coordinate measuring machines (CMMs)
- Support calibration activities for measuring and test equipment, including scheduling, performing routine calibrations, documenting results, and maintaining calibration records
- Assist with validation execution activities (IQ, OQ, PQ) for processes, equipment, and software under QA oversight
- Perform environmental monitoring and cleanroom compliance checks where applicable
- Identify, document, and segregate nonconforming materials and products in accordance with NCR processes, escalating findings as required
- Participate in material review board (MRB) activities by presenting inspection findings and nonconformance data
- Collect, record, and maintain accurate inspection and test data, ensuring traceability and completeness of quality records, including Device History Records (DHRs)
- Maintain organized, audit-ready documentation including inspection records, test logs, and calibration certificates
- Support CAPA implementation activities, including execution of corrective actions, verification of effectiveness, and reporting results
- Assist with packaging and labeling inspections to ensure compliance with specifications and regulatory requirements
- Support internal audits and external inspections (e.g., notified bodies, customers, regulators) by preparing inspection areas, retrieving records, and demonstrating processes
- Communicate quality issues, trends, and observations to QA and cross-functional teams in a timely manner
- Follow all applicable quality system procedures, work instructions, safety protocols, and regulatory requirements
- Contribute to continuous improvement initiatives by identifying inefficiencies and supporting quality improvement projects
Qualifications:
- College diploma or bachelor’s degree in Engineering Technology, Manufacturing Technology, Quality Assurance, Life Sciences, or a related technical field
- Minimum 3 years of hands-on quality inspection experience in a medical device, pharmaceutical, or other regulated manufacturing environment
- Working knowledge of inspection methods, sampling plans, and acceptance criteria for mechanical, electrical, or electromechanical components and assemblies
- Hands-on experience with precision measurement instruments (e.g., calipers, micrometers, height gauges, pin gauges, optical comparators, CMMs)
- Familiarity with ISO 13485 requirements related to inspection, testing, calibration, and production quality activities
- Experience supporting calibration activities, including execution and documentation
- Ability to read and interpret engineering drawings, specifications, work instructions, and inspection procedures
- Strong attention to detail and accuracy in documentation and record-keeping
- Strong written and verbal communication skills in English
- Ability to work collaboratively with Manufacturing, Engineering, and Quality teams
Preferred Qualifications
- ASQ Certified Quality Inspector (CQI), Certified Quality Technician (CQT), or equivalent certification
- Experience in a medical device manufacturing environment subject to FDA and/or MDSAP requirements
- Familiarity with FDA QMSR (21 CFR Part 820), EU MDR, and MDSAP inspection expectations
- Experience supporting IQ/OQ/PQ validation activities
- Experience with electronic Quality Management Systems (eQMS)
- Knowledge of statistical techniques such as SPC, capability analysis, or sampling plans (e.g., ANSI/ASQ Z1.4)
- Familiarity with cleanroom manufacturing and environmental monitoring requirements
- Experience supporting regulatory inspections, notified body audits, or customer audits
- Knowledge of GD&T (Geometric Dimensioning and Tolerancing)
- Experience with soldering inspection (IPC-A-610) or similar workmanship standards
What We Offer:
- A unique opportunity to shape the future of connected healthcare.
- Competitive salary and comprehensive benefits.
- A collaborative, fast-paced environment where innovation and impact go hand-in-hand.
- Opportunities for professional growth in a mission-driven company poised for global expansion.
- Exposure working in one of the most innovative and forward-thinking tech company
Join us, and help build a healthier, more connected future.
