מדעים/ביוטק

Quality Assurance Engineer

439200

תאריך עדכון

26/05/2022

תיאור המשרה

Quality Assurance Engineer - Job description

Job description:

Responsible for designing, implementing, and maintaining an effective quality system according to ISO3485 and 21CFR part 820.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

· Support internal/external audits and inspections and provide post-audit follow-up information, as requested

· Analyze product complaints.

· Update quality procedures according to relevant regulations

· Support the HR department with its procedure implementation; Identify and assure performance of the organization training requirements to meet the quality standards

· Prepare or maintain technical files as necessary to obtain and sustain product approval.

· Maintain all aspects of the quality system and its implementation throughout the organization

· Plan, perform and oversee inspection and testing of products to ensure the quality deliverable

· Develops, implements, and manages processes to ensure that products meet required specifications for quality, function, and reliability prior to delivery.

· Detect coaching needs and take actions in accordance with these needs to ensure compliance with quality standards

· Support the management review meetings.

REQUIREMENTS

· 2+ years’ experience as a QA engineer.

· Knowledge & experience of ISO3485 and 21CFR part 820

· Certification, such as Quality Engineer, Quality Auditor, or Quality Improvement Associate, is preferred

· Full working proficiency in English

· Excellent communication skills, both verbal and written

· Able to write and update quality procedures.

· Proficient in Microsoft Office including Excel, PowerPoint.

· Possesses and applies problem-solving skills.

· Able to work with details and complete assignments with minimal supervision.

· Highly motivated and goal oriented.

· Team player.

· Very high communication.

· Able to negotiate and build relationships at all levels. 

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