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Sr Quality Systems Engineer

hace 3 meses

Tijuana, Baja California, México Haemonetics A tiempo completo

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

JOB SUMMARY:

Responsible for developing and coordinating implementation of quality systems, procedures, test methods, problem definitions and resolutions for existing and new products in compliance with QMS.

ESSENTIAL DUTIES:

Duties are listed in order of greatest importance. The incumbent may be asked to perform other function-related activities in addition to the below mentioned responsibilities as reasonably required by business needs.

  • Conducts internal or external audits as assigned to ensure compliance to company quality systems requirements.
  • Develops, reviews and challenges existing quality driven test systems and procedure to assure products meet intended use.
  • 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.
  • Lead teams/projects related to Complaint investigation, CAPA, cost reduction, and quality system excellence. Use of TQM tools including Six Sigma may be required.
  • Maintains records to ensure compliance to GMP/ISO requirements.
  • May lead design review of new platform or product and assures that appropriate tests are performed to achieve sigma level for quality expectations.
  • May maintain an active role in supplier and new business assessment and development.
  • May manage and lead CAPA program, implementing global CAPA policies.
  • Required to have specific product or process expertise to fit business needs.

MINIMUM REQUIRED EDUCATION AND EXPERINCE:

  • Bachelor's Degree - Engineering or Life Science discipline or related technical field
  • 3 years work experience in the medical device industry
  • Statistical process control experience

SKILL SETS

  • Computer knowledge and experience with Microsoft Office
  • Preferred Six Sigma certification

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