Responsibilities
Provide strategic leadership for the Quality Assurance and regulatory affairs function, fostering a culture of continuous improvement.
Oversee the upkeep and improvement of our ISO 9001-compliant Quality Management system, ensuring its effectiveness in meeting quality objectives.
Lead all the system verification and validation activities that are required to release the system for production.
Design and define testing methods, including acceleration and long-term reliability tests.
Develop and execute QA manual automation s TEST scripts using industry-standard tools.
Conduct regression, performance, and functional tests on NPI products.
Oversee customer complaints, non-conformance, and corrective action processes, ensuring timely and effective resolution.
Lead the preparation, coordination, and management of internal and external inspections and audits.
Stay current on evolving government and industry quality standards, ensuring compliance with all relevant regulations.
Requirements: Qualifications
BSc degree in system, mechanical, material Engineering, or a related field.
Minimum 5-7 years of experience in a Quality Assurance or Regulatory Affairs role within a manufacturing or related environment.
Proven experience in implementing and maintaining an ISO 9001 Quality Management system.
Strong understanding of quality control principles, statistical process control (SPC), and quality improvement methodologies (Six Sigma, Lean Manufacturing, etc.).
Excellent leadership, communication, and interpersonal skills with the ability to motivate and collaborate across teams.
Demonstrated ability to manage and prioritize multiple tasks effectively in a fast-paced
Meticulous attention to detail and a commitment to quality.
Proficient in Microsoft Office Suite (Word, Excel, PowerPoint).
Proficient in Priority ERP - Advantage.
Fluency in English; additional language skills a plus.
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