join us! an innovative company at the forefront of medical technology with a collaborative and dynamic team environment is looking for QA Manager.
employment type: part-time (1-2 days a week).
responsibilities:
develop, implement, and maintain the quality management system (qms) in compliance with iso 13485, eu mdr, fda 21 cfr 820, and other applicable regulations.
ensure proper documentation, control, and regular review of sops, forms, policies, and records.
manage quality manual updates and ensure alignment with regulatory requirements.
prepare for and support internal, customer, and regulatory audits (e.g., iso 13485 audits, fda inspections, notified body assessments).
lead gap analyses, audit responses, and follow-up capa plans.
lead investigations into nonconformities and complaints, including root cause analysis.
develop and implement effective corrective and preventive actions (capas).
maintain oversight of all quality events, deviations, and nonconformances.
evaluate, qualify, and monitor suppliers and service providers.
conduct supplier audits and manage supplier corrective actions.
work closely with production and engineering to implement in-process controls.
participate in design transfer activities and process validations (iq/oq/pq).
train company employees to ensure team capabilities align with company needs.
location: hasharon.
please send your cv to us.
employment type: part-time (1-2 days a week).
responsibilities:
develop, implement, and maintain the quality management system (qms) in compliance with iso 13485, eu mdr, fda 21 cfr 820, and other applicable regulations.
ensure proper documentation, control, and regular review of sops, forms, policies, and records.
manage quality manual updates and ensure alignment with regulatory requirements.
prepare for and support internal, customer, and regulatory audits (e.g., iso 13485 audits, fda inspections, notified body assessments).
lead gap analyses, audit responses, and follow-up capa plans.
lead investigations into nonconformities and complaints, including root cause analysis.
develop and implement effective corrective and preventive actions (capas).
maintain oversight of all quality events, deviations, and nonconformances.
evaluate, qualify, and monitor suppliers and service providers.
conduct supplier audits and manage supplier corrective actions.
work closely with production and engineering to implement in-process controls.
participate in design transfer activities and process validations (iq/oq/pq).
train company employees to ensure team capabilities align with company needs.
location: hasharon.
please send your cv to us.
Requirements:
requirements for position:
bachelors degree in engineering, life sciences, or a related field (required).
minimum 3 years of experience in Quality Assurance within the medical device or related regulated industry.
proven experience managing a qms in accordance with iso 13485 and 21 cfr 820.
familiarity with eu mdr and iso 14971
strong knowledge of capa, ncs, complaints, risk management, internal audits, and document control.
excellent analytical, communication, and leadership skills.
fluent in english (spoken and written); additional languages are a plus.
requirements for position:
bachelors degree in engineering, life sciences, or a related field (required).
minimum 3 years of experience in Quality Assurance within the medical device or related regulated industry.
proven experience managing a qms in accordance with iso 13485 and 21 cfr 820.
familiarity with eu mdr and iso 14971
strong knowledge of capa, ncs, complaints, risk management, internal audits, and document control.
excellent analytical, communication, and leadership skills.
fluent in english (spoken and written); additional languages are a plus.
This position is open to all candidates.
