Quality Engineer

General Description of Job:  The Quality Engineer supports the Snr Quality Manager in ensuring the company’s operations, processes, products, facilities, and supply chain meet established quality standards and regulatory requirements.  This role involves assisting in the implementation and monitoring of quality control measures, participating in audits, and helping to resolve quality-related issues. The Quality Engineer also contributes to the maintenance of the ISO 13485 Quality Management System (QMS) and supports continuous improvement initiatives.

Main Function:

Supports the Quality Management of the company's operation through assistance in the management of processes, products, facilities, and supply chain. Assists in ensuring manufacturing compliance to FDA/GMP and established ISO 13485 Quality System Requirements.

Primary Tasks:

• Assists in the implementation and monitoring of quality conformity through internal audits and the assessment of quality results.

• Helps to maintain up-to-date local and international regulatory records/information.

• Assists in the preparation of monthly quality progress reports.

• Maintains QC department equipment in good operating condition.

• Validation and monitoring of outsource laboratory facilities for product quality testing.

• Assists in the administration of a program of hygiene to safeguard the health and welfare of the personnel as well as the product against contamination.

• Verifies and reports any non-conformance of quality pertaining to product, service, and processes.

• Performs documentation under the QMS scope.

• Assists in the resolution of product quality complaints.

• Assists in the resolution and closure of NCR received from either internal departments or external bodies.

• Planning and monitoring the calibration of all measuring equipment.

• Assists in the dissemination and communication of QMS to relevant personnel.

• Supports IQC, IPQC, OQC, and docking audits.

• Performs and ensures proper control of non-conformance material/product.

• Maintaining effective programs for: Quality Control, Waste Control, Safety, General Housekeeping, and overseeing Preventative Maintenance.

• Collaborates with the Snr Quality Manager in the resolution of quality issues under the QMS.

• Assists in the creation, review, and/or revision of procedures and processes to increase quality assurance level.

• Facilitates customers’ or 3rd parties’ audit for system compliance and qualification.

• Participates in continual improvement initiatives relating to quality assurance.

• Assists in the implementation of corrective and preventive actions arising from any form of quality concerns.

• Assists in the development and verification of SOP and its related processes necessary for the achievement of all ISOs certification requirements.

• Develops new SOPs for new processes as part of the ISO requirement.

• Assists in hardware and technology transfer/setup.

• Assists in the commissioning of new capabilities (machineries and processes).

• Work closely with intercompany QA teams to align on best practices and methodologies

• Performs other tasks as assigned.

• Manage the team of QC Inspectors including recruitment, performance management, mentoring.

Qualification Requirements:

• Bachelor’s degree in a relevant field (e.g., Engineering, Quality Management - ISO 13485 preferred)

• 1-3 years of experience in a quality assurance/quality control role, preferably in a medical device manufacturing environment.

• Strong understanding of quality management systems, industry regulations and standards (e.g., ISO 9001, ISO 13485, FDA, GMP).

• Familiarity with quality control tools and techniques.

• Good documentation and record-keeping skills.

• Skill in data collection, analysis, and reporting.

• Strong attention to detail and problem-solving abilities.

• Ability to interpret technical documents and specifications.

• Effective communication and interpersonal skills to collaborate with cross-functional teams.

• Ability to work independently and as part of a team.