Quality System Engineer

Haemonetics

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Job Description

We are constantly looking to add to our core talent. If you are seeking a career that is challenging and rewarding, a work environment that is diverse and dynamic, look no further — Haemonetics is your employer of choice.

Job Details

Conducts Post-Market trending and analysis with a focus on identification and escalation of Safety and Quality issues; seeks to improve reporting processes to ensure unified approach
Develops and promotes data mining and data visualization tools to monitor trends
Collaborates with complaint handling units, R&D, Field Service, and other stakeholders through complaint review meetings as well as prepare data for presentation in Executive Leadership, Board of Directors, and/or Quality Management Review meetings.
Proactively identifies, communicates, and refers problems or coordination needs to leadership team; provides timely detailed background/data to support problem resolution; seeks guidance as necessary to respond to needs or changes, and quickly assesses requirements to meet target milestones, goals, and deadlines. Takes initiative to offer suggestions for improved methods, processes, products, services, or techniques. Assists in manufacturing quality systems, product quality, and customer quality requirements.
Work with relevant departments and stakeholders to investigate CAPA, non-conformances, defects, and process failures in general in order to identify areas in need of process improvement, to determine the cost of quality and to lead or participate in resolution.
Completes or may lead teams/projects related to Complaint investigation, CAPA, cost reduction, design changes, new products, and quality system excellence.
Maintains records to ensure compliance to GMP/Regulatory requirements.
Monitors internal and external quality levels to trigger and drive improvements to maintain product compliance.
Provide individual contribution in problem solving efforts on selected projects to improve quality.

Job Requirement

Degree in Engineering or Science discipline or equivalent
Minimum 2 years working experience in manufacturing environment
Fresh graduate who are participating in MedTech Talent and Employment program are encourage to apply
Knowledge in problem solving, root cause analysis, statistical analysis, and data visualization (Tableau, Python)
Knowledge in Oracle ERP system will be an added advantage

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