Quality Engineer

Company Description:

neoLaser designs, manufactures, and distributes top-notch quality medical laser products with superb performance, flexibility, and affordability. The company holds an ISO13485 certification as well as clearances in over 40 countries for its high-end medical laser systems. Our flagship product, the neoV laser, offers state-of-the-art options for Endovascular and Proctology treatments, including unique surgical probes for minimally invasive surgery.

Role is 80% of full time employment (4 days a week)

Key Responsibilities:

·    Support continuous improvement initiatives across the Quality Management System, ensuring processes meet industry standards and regulatory requirements.

·    Assist in maintaining and updating QMS documentation, procedures, and records to reflect evolving standards.

·    Work with cross-functional teams to embed quality standards into each stage of product development and production.

·    Conduct and take part in audits and assessments, supporting the identification and implementation of improvements (CAPA).

·    Participate in training and knowledge-sharing initiatives to foster a quality-centered approach across the organization.

·    Support V&V processes and provide in-process QA support including inspection and document review (DHRs).

·    Manage aspects of internal quality system relating to receiving inspection, calibration, MRB, etc.

·    Interact with suppliers and subcontractors and assist in Suppliers evaluation and control

·    Manage aspects of Complaints handling, RMA and servicing activities

Qualifications:

·   Bachelor’s in Mechanical/Biomedical/Industrial Engineering or equivalent

·   Previous Experience (2+ years) as QA engineer

·   Proficient in English (reading and writing)

·   Knowledge or experience with ISO 9001, ISO 13485, and medical device-related applications is highly beneficial.

·   Strong analytical skills, highly detail oriented, self-motivated, team player with a proactive approach to problem-solving.

• Please send relevant application to: [email protected]