Quality Assurance Engineer - 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.
· 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.