Quality Systems Analyst

  • Randstad
  • 4000.00 - 5000.00
  • 32-40 hours
  • Master degree

Client

Our client is a leading company in the flied of projectmanagement and engineering of companies from all over the world.

Client

Our client is a leading company in the flied of projectmanagement and engineering of companies from all over the world. Their reputation is based on making succesfull partnerships with their clients, provide them innovative designs and cost-efficient solutions in the context of healthy judgement ability, strong management en technical excellency.

They provide Full Service Engineering for their clients, among which project and programmanagement, purchase, design, construction management, health- and safetymanagement, commissioning, qualification and start-up of many projects in a vast amount of marketsectors.

Requirements

  • University / bachelor’s Degree or Equivalent.
  • A minimum of 2 years related experience. Medical device manufacturing experience preferred.
  • Lean/Six Sigma Green Belt and a background in Statistics.
  • Able to communicate and have writing skills in English.
  • Mathematical and analytical thinking skills.
  • Minimum of 3 years in similar environment with medical device or pharmaceutical.
  • Thorough understanding of medically regulated plant operations including knowledge of industry standards and regulations.
  • Experience in dealing with audits preferred (Notified bodies and/or Competent Authorities).
  • Flexibility, integrity, independency and serve minded.

What do you get?

  • Pension entitlement as from day one
  • Collective WGA / WIA insurance
  • NBBU / ABU collective labor agreement
  • 25 holidays days
  • 8,33% holiday allowance
  • 100% payment in case of illness after one waiting day
  • Travel allowance

Duties

  • Ensure the overall management and effectiveness of the NC and CAPA processes.
  • Work effectively with other NC and CAPA site leaders to ensure consistent systems and processes.
  • Maintain regular interface with management.
  • Assist in the development of quality metrics.
  • Provide education and training as needed regarding the NC and CAPA processes, including bounding and failure investigation/ problem solving.
  • Ensure compliance of NC process, CAPA process and assigned projects with the FDA Quality System Regulation, ISO13485, MDD, CMDR and other industry standards as applicable.
  • Provides Regulatory Affairs documents when required by affiliates and/or Regulatory Affairs team.
  • Lead and participate in quality system improvement initiatives.
  • Conduct internal audits to determine compliance with quality management system standards as well as regulatory and customer requirements.
  • Determine root causes of quality issues and develops corrective action and recommendations.

TAGCLOUD

qualitysystems
#qualityassurance
#QA
#nonconformance
#medicaldevices
#ISO
#GMP
#CAPA
Peter Debrichy

Interested

Send your resume to peter@tailorminds.com referring to job id (1188)

More information?

Please contact Peter Debrichy working at our office in Zoetermeer, phone number +31 6-10191580

APPLY USING THE FORM BELOW

  • Max. file size: 64 MB.
  • Hidden
  • Hidden
  • This field is for validation purposes and should be left unchanged.
Menu