Quality System Engineer

2 weeks ago

Butterworth, Penang, Malaysia Haemonetics Software Solutions Full time

Haemonetics is committed to the protection of personal data in accordance with applicable laws and regulations.

The editor and data controller of www.haemonetics.com is Haemonetics Corporation, 125 Summer Street, Boston, Massachusetts, 02110 U.S.A. The global Data Privacy Officer of Haemonetics can be reached at this address.

Time left to apply End Date: April 15, 2025 (18 days left to apply)

Job requisition id R9365

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.

Responsibilities
  • Conducts internal or external audits as assigned to ensure compliance to company quality system requirements.
  • Generates daily, weekly, or monthly trending reports; seeks to improve reporting processes to ensure unified approach and procedures. Presents reports and materials at business unit meetings and updates reports as appropriate with any key issues or customer concerns.
  • Manages the process to gather and communicate quality systems Key Performance Indicators across the organization.
  • Manage/lead all quality related functions. Plan and strategize department priority and focus.
  • Develops, reviews and challenges existing quality driven test systems and procedures to assure products meet intended use.
  • Responsible for the release of product from sterilization and to make disposition of the inspected component and product.
  • Insures that full range of six sigma tools are used when appropriate for product and process changes in Braintree plan, particularly new products.
  • Key contributor in the design review of new or modified products. Challenge design assumptions to assure design intent manufacturability and customer acceptance levels are achieved and in compliance with Haemonetics SOPs and regulatory standards.
  • Leads product improvement projects and consults on supplier changes to ensure qualifications are met.
  • Leads teams/projects related to Complaint investigation, NCE, cost reduction, and quality system excellence. Use of TQM tools including six sigma is required.
  • Review and approve calibration logs.
  • Maintain, review and approve documents/records to ensure compliance to GMP/ISO requirements.
  • May lead design review of new platforms and assures that appropriate tests are performed to achieve sigma level expectations for quality.
  • May maintain an active role in supplier and new business assessment and development.
  • May manage and lead NCE/CAPA program, implementing global NCE/CAPA policies.
  • Required to have specific product or process expertise to fit business needs.
Requirements
  • Degree in Engineering or Science discipline or equivalent.
  • Minimum 3 years working experience in manufacturing environment.
  • Fresh graduates who are participating in MedTech Talent and Employment program are encouraged to apply.
  • Knowledge in problem solving, root cause and statistical analysis. Knowledge in Oracle ERP system will be an added advantage.

Throughout our history, we have earned a solid reputation for product innovation, technical expertise, and operational excellence. Today, our products, internal research and development, marketing partnerships, and product acquisitions reflect our unwavering commitment to provide safe and available blood for patient transfusions and for use in pharmaceuticals. We rely on our talented global workforce to help us achieve our mission of providing innovative medical devices that advance the safety, quality, and availability of the world's blood supply. To achieve our business goals and objectives, we are committed to attracting and retaining the best and brightest talent while offering a challenging, dynamic, and exciting work environment that offers professional growth and development.

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