Koch
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Engr, Quality QMS

Description

What You Will Do In Your Role

  • Standardize the medical quality system in GSP site and share the best practice improvements.

The Experience You Will Bring

Requirements:

  • 5 years’ minimum experience in Medical environment production and quality management or engineering management.
  • High level understanding in ISO 13485 & FDA including 21 CFR part 820 industry standards.
  • Has personal experience on developing MVP (master validation plan) including IQ, OQ and PQ elements of a process validation.
  • Experience on supporting medical product launchings and / or mass production product transfers from the ISO 13485 and FDA compliance.
  • Has actively participated in regulatory agency audits for medical and customer system and product audits based on standards fulfilling audit requirements under audit time pressure and closing pending items after words.
  • Team player with excellent leadership skills including interpersonal, oral and written capabilities coupled with a pro-active and hands-on working mentality
  • Strong Decision-making skills, sense of accountability, prioritization skills and ability to maintain confidentiality
  • Strong analytical skills, supplier/customer relation skills
  • Working knowledge of Statistical analysis, SPC, PPAP, FMEA, GD&T, Gage R&R and Control Plans.
  • Working knowledge and implementing quality management system of IATF 16949, ISO 9001, and ISO 13485 and other related management system standards and ISO 19011.
  • Knowledge in customer requirements VDA6.3, BIQS and MSA-Q1. (Desirable)
  • Layered Process Audit LPAs (CQI-8)
  • Comfortable working in a fast paced & high-volume environment
  • Excellent communications, negotiation, and presentation skills
  • Fluent in English
  • Proven experience on reviewing and closing gaps versus customer specific requirements, regulatory, etc, based on 1st, 2

    Education

    • Bachelor Degree
    • English Advanced

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