לוח משרות דרושים מכשור רפואי בצפון

Highly skilled and motivated Quality Design Engineer to join our dynamic team in the medical device industry.

The ideal candidate will have a strong background in design control, quality assurance, and regulatory compliance, with the ability to work collaboratively with R&D, Engineering, Regulatory and other teams.
Adaptable and possess a deep understanding of the regulatory landscape governing medical devices, specifically experience in all phases of product life cycle (design, development, risk management, design verification, production) in adherence with ISO13485:2016, 21 CFR 820 and ISO14971.
Main Duties:
- Lead and implement design control and production processes to ensure compliance with industry standards and regulations.
- Lead proactive design assurance activities facilitating the development and release of high-quality products.
- Collaborate with cross-functional teams to integrate quality into the design and development and manufacturing process.
- Stay abreast of evolving regulatory requirements for medical devices and ensure the company's adherence to relevant standards.
- Work closely with R&D teams to understand design requirements and provide quality engineering input throughout the product development lifecycle.
- Conduct design reviews to identify and address potential quality issues early in the process.
- Responsible for reviewing, providing input and approving product development DHF documentation (design planning, inputs and outputs, design review, V&V protocol -reports, risk analysis, and design change, product transfer to operations, etc).
- Responsible for approval of product design changes and process changes (ECO).
- Participate in Design Reviews for product teams as the quality expert, reviewer, and approver.
- Implement risk management processes and methodologies in the design and development phases per ISO 14971.
- Participate in risk assessments and develop strategies to mitigate potential risks.
- Establish and maintain quality assurance procedures to ensure product quality and regulatory compliance.
- Conduct audits and assessments to identify areas for improvement and implement corrective actions.
- Conduct Failure investigations for Complaints and CAPA.
- Responsible for approval of equipment qualification and process validation documents (pFMEA, IQ, OQ, PQ, etc).
- Perform supplier audits and provided support in preparation and performance of external audits to ensure quality and regulatory requirements are met.
- Support continuous improvement activities to reduce product failure rates.

Job Description As a Quality Assurance Leader, you will be responsible for conducting Afimilk’s day-to-day product quality activities. Your role is to ensure that Afimilk’s final products adhere to the established quality standards. Your responsibilities encompass conducting routine and quality inspections, identifying, and resolving workflow and production issues, training, investigating customer complaints, performing supplier evaluations and audits, and review of product specifications and quality control plans. Essential Duties and Responsibilities include the following (Other duties may be assigned):
* Day-to-day quality engineering activities such as product quality documentation, incoming inspection, customer complaints, , product deviation, non-conformities, Document control and fields corrective action
* Conducting incoming inspection and evaluating the compliance of products or with requirements, specifications, or standards.
* Conducting audits at manufacturers and subcontractors, performing source inspections according to specified drawing/work instructions and quality requirements.
* Managing quality processes in the manufacturing, including monitoring, and controlling processes, preparing quality reports and analyses, and maintaining relevant documentation.
* Conducting quality inspections on suppliers and incoming raw materials to the factory and ensuring their compliance with required quality standards.
* Responsible for leading and implementing IPQC, IQC, OQC approval to supplier.
* Establishing metrics and criteria for monitoring suppliers and subcontractors. · Collaborate with Operations, R&D QA, Engineering and Manufacturing functions to ensure quality standards are in place. · Validation of manufacturing process to meet targets, production output and quality standards.