לוח משרות דרושים מכשור רפואי משרה מלאה

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.

n this role, the Engineering & Manufacturing Quality Manager leads Sr. Quality Engineers, Quality Engineers and personnel who provide quality oversight the Ops Quality platform, such as Engineering, process validations, production lines development and qualifications, material acceptance, Quality presence at production and manufacturing failure investigations while working within a multi-functional team environment for medical devices. The Quality Engineering & Manufacturing Manager leads personnel who review and approve projects, tasks and nonconformities, from product realization, design transfer, production process establishment and changes, production controls and manufacturing supervision and plays an active role to ensure that production processes meet all applicable quality standards, consistent with internal procedures and acceptance criteria, while meeting applicable regulatory requirements. The Quality Engineering & Manufacturing Manager will be a strong advocate for product and process quality at all stages. Additionally, this role leads Sr. Engineers responsible for the medical devices sterilization methods establishment, validation, control, and maintenance activities. Furthermore, the Quality Engineering & Manufacturing Manager leads personnel who are responsible for the production documentation (DHR) and finished product release to market by monitoring the manufacturing and release processes, including a verification that the sterilization and Endotoxin levels meet the applicable requirements.

The Quality Engineering & Manufacturing Manager will support continuance improvement of product, process and QMS and provide guidance and support to all duties associated with the auditing and documentation of compliance related items against GMP and ISO standards for West and its subcontractors. The Quality Engineering & Manufacturing Manager will also lead a team executing the QMS related transactions in relevant GMP systems (Master Control, SAP, Share Point) and other relevant quality functions as applicable including external and internal audit support.

In this role, the QA Engineer supports products development and provides quality oversight to the R&D activities while working within a multi-functional team environment for medical devices.

The QA Engineer will play an active role to ensure the design and development process meets quality standards consistent with internal procedures and acceptance criteria, while meeting all design control and applicable regulatory requirements as well as being involved in QA activities.



Essential Duties and Responsibilities:



QA focal point for R&D projects in design and development processes.
Provide guidance on documentation structures and format to ensure compliance to procedures, relevant regulations and standards
Responsible for final approval of R&D documentation- reviewing and approving technical and DHF documentation.
Responsible for approval of product development DHF documentation (DDP, PRD, TMX, design verification & validation activities, dFMEA risk documents, test methods, protocols, reports, product design transfer)
Responsible for approval of product design changes
Finding solutions for queries within responsibility limits
Assist and provide guidance on any out of specification result, deviation, or excursion that may occur
QA representative in product development design reviews
Work cross-functionally with individuals and project or extended teams to provide guidance and ensure success of projects
Attend program meetings as required as part of extended program teams

ART MEDICAL is a well-funded medical startup, developing cutting-edge technologies and products for the treatment of ICU patients. Our smART+™ platform is an intelligent, multi sensor-based enteral feeding system for the treatment in critical care patients, that aims to prevent life-threatening complications, and helps ICU patients recover faster and better. We are looking for an experienced, highly motivated and talented Project Manager to join us. If you are a self driven, team player, have a can-do and problem-solving attitude, and want to impact the future of patient care in the ICU, then you may be the person we are looking for! As a Project Manager at ART, you will be responsible for leading, managing, and executing multi-disciplinary projects plans and activities in compliance with Medical Device 13485 standards. The primary objective is to effectively achieve planned specifications, quality standards, timelines, and budgetary constraints and to continually improve the lifecycle management process. You will be responsible for highlighting needs to assure technical proficiency and quality deliverables. We offer a collaborative, multi-disciplinary workplace, a chance to learn with and from interesting and enthusiastic colleagues. A rapidly growing, working environment and growth opportunities.