Quality System Engineer

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Batu Kawan, Selatan, Pulau Pinang
Healthtech
The Role

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

Essential Duties

  • Coordinate the return of product samples; perform visual inspection and preliminary investigations related to product issues; forward samples and preliminary investigation reports to responsible departments; review the responses; and notify the customer of the result.
  • Partner with Field Service, Marketing, Manufacturing, Quality and Sales personnel to help resolve customer issues.
  • Partner with manufacturing facilities to analyze failure, CAPA to respond to customer complaints (PIR).
  • Actively provide individual contributions in problem solving efforts to improve quality.
  • The incumbent may be asked to perform other function-related activities in addition to the above mentioned responsibilities as reasonably required by business needs.
  • Comply with the ISO14001 Environmental Management System policy, SOP and requirements
  • Continuous support to the development and implementation of program to achieve and maintain the ISO 14001 environmental management system.
  • Perform other tasks as required.

Supervisory Responsibilities: None

Qualifications

Education

Bachelor's Degree in Engineering - Required

Experience

1+ years: post qualification experience in quality with a focus on manufacturing and distribution - Required

1-3 years: Experience in regulated industries (automotive, aerospace, Medical Devices) - Preferred

Skills

  • Demonstrated analytical skills
  • Effective interpersonal skills
  • Demonstrated written communication skills
  • Strong verbal communication and listening skills
  • Demonstrated problem-solving skills
  • Assumes personal responsibility for actions
  • Good Team Player
  • Proficient in English written and verbal communication skills

Training/Certifications

  • Knowledge of ISO in a regulated industry (Medical Devices, Aerospace, Automotive, etc.) preferred: ISO 13485 & 21 CFR 820, MDD & MDR regulations/guidelines - Preferred
  • Class II or Class III medical devices requirements - Preferred

EEO Policy Statement

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The Company
HQ: Boston, MA
1,993 Employees
Year Founded: 1971

What We Do

Haemonetics (NYSE: HAE) is a global healthcare company dedicated to providing a suite of innovative medical products and solutions for customers, to help them improve patient care and reduce the cost of healthcare. Our technology addresses important medical markets: blood and plasma component collection, the surgical suite, and hospital transfusion services. To learn more about Haemonetics, visit www.haemonetics.com.

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