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Position Overview

The Quality Control (QC) Inspector is responsible for performing incoming, in-process, and final inspections to ensure that materials, components, subassemblies, and finished products meet approved specifications, drawings, quality requirements, and applicable procedures.

Roles and Responsibilities

• Perform Quality Control inspections, including incoming inspection of raw materials and components, in accordance with approved drawings, specifications, procedures, and quality requirements.
• Perform in-process inspections of components and subassemblies, as well as final inspection of finished products, including inspections performed in a cleanroom environment.
• Document inspection, measurement, and test results in accordance with the company’s Quality Management System (QMS) and applicable procedures.
• Identify and document nonconformities and out-of-specification results, and support related investigations, supplier communication, and corrective actions, as applicable.
• Review Device History Records (DHRs) and related manufacturing documentation for completeness, accuracy, and compliance with approved procedures and specifications.
• Perform dimensional and visual inspections using OGP systems, calipers, gauges, micrometers, rulers, and other inspection and measurement equipment.
• Perform microbiological and environmental monitoring activities within the cleanroom, in accordance with applicable procedures.
• Collaborate with Manufacturing, Quality, Engineering, and other relevant functions to address quality issues and ensure compliance with product and process requirements.

Qualifications and Preferred Skills

• More than 5 years of experience in Quality Control within the medical device industry, including experience working with technical drawings and specifications.
• Experience working in a GMP and/or ISO 13485:2016-regulated environment is preferred.
• Hands-on experience with dimensional measurement and inspection equipment.
• Experience working with catheters and/or catheter-based medical devices is an advantage.
• Experience working in a cleanroom environment is preferred.
• High attention to detail, accuracy, and strong documentation skills.
• Good communication and interpersonal skills.
• Good written and verbal English, with the ability to read and understand technical documentation.
• Ability to work independently as well as collaboratively within a multidisciplinary team.

Temporary Position – Maternity Leave Replacement

Position Overview

The Quality Design Control Engineer is responsible for supporting and leading design control and product quality activities throughout the product lifecycle, ensuring compliance with applicable regulatory requirements, international standards, and company procedures.

Roles and Responsibilities

• Lead and maintain Design Control activities in accordance with ISO 13485:2016, applicable regulatory requirements, and internal procedures, including design changes, impact assessments, design reviews, Verification and Validation (V&V) activities, product configuration management, traceability, and Design History File (DHF) documentation.
• Lead the preparation, review, execution, and documentation of Design Verification and Validation (V&V) activities, including protocols, reports, deviations, and supporting documentation.
• Maintain and continuously update the Risk Management File in accordance with ISO 14971, including risk analyses, risk-control measures, verification of risk-control effectiveness, and benefit-risk assessments, as applicable.
• Ensure that product designs and design changes comply with applicable regulatory requirements, standards, design inputs, specifications, and internal procedures.
• Support design transfer and configuration management, ensuring consistency between approved design documentation, product specifications, manufacturing documentation, and released product configurations.
• Lead and coordinate product-related qualification and validation activities, including sterilization validation, biocompatibility assessments, packaging and transportation validation, shelf-life activities, and preclinical studies, as applicable.
• Support facility, equipment, and process qualification and validation activities, as required.
• Collaborate cross-functionally with R&D, Manufacturing, Regulatory, Clinical, and Operations teams to ensure that quality and regulatory requirements are appropriately incorporated throughout product development and implementation of design changes.
• Support investigations, CAPAs, nonconformances, and change-control activities where design- or product-related assessment is required.

Qualifications and Preferred Skills

• B.Sc. in Biomedical Engineering, Mechanical Engineering, Life Sciences, or another relevant scientific or engineering discipline.
• Minimum of 3 years of experience in Design Control and/or Quality Engineering within the medical device industry. Experience with cardiovascular or other Class III interventional medical devices is preferred.
• Strong knowledge of and practical experience with ISO 13485 and ISO 14971.
• Familiarity with applicable medical device standards, including ISO 10993, ISO 11135, ISO 11607, and other relevant product-specific standards.
• Hands-on experience with design changes, risk management, V&V activities, technical documentation, and DHF maintenance.
• Strong technical understanding and the ability to evaluate the potential impact of design and manufacturing changes on product safety, performance, and regulatory compliance.
• Excellent attention to detail, accuracy, and technical documentation skills.
• Strong communication and cross-functional collaboration skills.
• Good written and verbal English communication skills.
• Ability to work independently, manage multiple priorities, and collaborate effectively within a multidisciplinary team.

We are seeking a System Engineer that will be responsible for the integration, and verification of an electronic sensing system for a catheter-based class III medical device. The role combines system engineering, electrical engineering, mechanical engineering, project integration, regulatory compliance, and test method development throughout the product lifecycle, from concept to commercialization.

Key Responsibilities

• Translate clinical, user, and business needs into measurable engineering
  requirements.
• System integration activities between electrical, mechanical, software, and
  catheter subsystems.
•  Support risk management activities in accordance with applicable medical
  device standards.
• Work closely with internal teams and external suppliers to ensure successful
  implementation
• Review electrical/mechanical designs, test results, and verification activities.
• Develop test protocols thorough understanding of applicable standards
•  Support interactions with regulatory bodies and certification agencies
  throughout the development process.
• Design and specify test fixtures, jigs, simulators, and measurement systems
  required for development and verification activities.

Requirements

• B.Sc. in Electrical Engineering/ Biomedical Engineering/ Systems Engineering, or related discipline.
• M.Sc. – Advantage.
• 5+ years of experience in multidisciplinary medical device development.
• Proven experience in development class III  medical device
• Hands-on experience with medical electrical devices.
• Experience with sensing technologies, signal acquisition systems, and electronic
  medical systems- Advantage
• Experience leading multidisciplinary projects involving hardware, software,
  mechanical, and system integration teams.
• Experience with catheter-based, cardiovascular, electrophysiology, or structural
  heart devices – Strong Advantage.
• Experience supporting regulatory submissions and external audits – Advantage.