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Job Opportunity: QA Associate Medical Device

Date   Nov 19
Listing No.   IE261789
Sector   Medical & Healthcare
Region   Center
City/Yishuv   Raanana
QA Associate Medical Device
Support cGMP/QSR systems compliance maintenance and improvement for medical device (mainly) and pharmaceutical products development and production: Handle documentation center, ECO, CAPA, DMR, internal audits and suppliers/distributors audits, SOP writing and improvement.

Duties & Responsibilities

Provide quality assurance support to development, production and product engineering with issues concerning QSR/cGMP requirements, regulations and guidelines for the different markets – EU, USA, etc.
Provide support on the follow-up on the ECO processes to ensure that correct implementation of ECO and other change control procedures pertaining to the product, manufacturing and quality control facilities.
Conduct internal audits in the company.
Provide support in conducting quality audits of raw material manufacturers, contract manufacturers, packaging materials manufacturers, contract laboratories and service providers for the purpose of evaluation and approval.
Provide support on the CAPA processes to ensure implementation of follow-ups and CAPA that derive from internal and contractor audits and evaluate effectiveness of CAPA
Provide support to the writing and approval of company procedures.
Provide support in supervising that the contractors’ qualification and service providers, as applicable, documentation within the company is current and that it is archived properly.
Provide support in training manufacturing, engineering, quality control and other personnel on the various relevant aspects of quality assurance.
Provide support in writing protocols and report of verification tests and validation studies pertaining to the drug or device products, the product transfer from R&D to manufacturing, the production processes, the equipment and systems of the manufacturing and quality control laboratories.
Provide support in ensuring that change in existing product and manufacturing processes are carried out and documented according to approved Engineering Change Order (ECO) or other change control procedures.
Provide support in handling all customer complaint issues, including the complaint investigation, the reporting to regulatory authorities as required, feedback to the customer.
Provide support in ensuring that all verifications and validations are performed on adequately functioning, calibrated, qualified equipment, and following written and approved operating instructions.
Provide support in supervising that the documentation to the above activities is handled, adequately indexed and archived according to relevant approved procedures.
Provide support in managing the documentation center and that the documentation is handled and archived therein.
Provide support in quality improvement programs throughout the Company.
Perform any other related duties as management may require from time to time.

List of qualifications

At least 5 years of experience in medical devices (and pharmaceutical advantage) industry.
Knowledge and Experience in Assurance medical device QSR (advantage of knowledge in Pharmaceutical Quality).
Fluent in English reading and writing.
Neatness and systematic thinking and working.
Typewriting, Microsoft Office word-processing and computer proficiency and skills.
Experience in technical and SOP writing.
Ability to view broad perspective of the organization's vision, objectives and interests.
Execution capabilities.
Excellent inter personal relations capabilities.
Life Science or Technical sciences related studies or Pharmacist, with training in pharmaceutical quality assurance (QSR/GMP)
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