Job Objective
Ensure compliance with the Quality Management System in accordance with ISO 13485, as well as regulatory and customer requirements, through effective management of validations, sampling plans, audits, customer complaint handling, and Incoming Quality activities, communicating effectively in English with international clients and suppliers.
Key Responsibilities
Maintain, implement, and continuously improve the Quality Management System in compliance with ISO 13485.
Experience on (SV,IQ, OQ, PQ,) validations as well as TMV’s, GR&R.
Develop and apply sampling plans and acceptance criteria in accordance with applicable standards (AQL, ISO 2859, or equivalent).
Manage and participate in internal and external audits (customers, certification bodies, regulatory agencies).
Investigate and follow up on customer complaints, including root cause analysis and corrective and preventive actions (CAPA).
Coordinate and perform Incoming Quality activities, including inspection, release, or rejection of materials, and communication with suppliers.
Prepare, review, and approve Quality Management System documentation (procedures, work instructions, forms, and reports).
Monitor quality performance indicators and report results to management.
Ensure compliance with traceability, change control, and risk management requirements.
Collaborate with Production, Engineering, Purchasing, and Regulatory Affairs teams.
Education Requirements
Bachelor’s degree in Industrial Engineering, Biomedical Engineering, Mechanical Engineering, or a related field.
Required Experience
Minimum of 3–5 years of experience as a Quality Engineer in a regulated industry (preferably medical devices).
Proven experience implementing and maintaining ISO 13485.
Experience with process and equipment validations.
Knowledge and application of statistical sampling and inspection plans.
Participation in internal and external audits.
Experience handling customer complaints.
Experience with Incoming Quality and supplier management.
Technical Knowledge
ISO 13485 and applicable regulatory requirements.
Quality tools: CAPA, FMEA, root cause analysis (5 Whys, Fishbone).
IQ/OQ/PQ validations.
Statistical sampling and statistical process control.
Documentation and record control.
Skills and Competencies
Strong analytical and problem-solving skills.
High attention to detail and sense of responsibility.
Effective verbal and written communication.
Ability to work under pressure and meet deadlines.
Teamwork and cross-functional collaboration.