Senior Quality Engineer

Support the growth and development of the Quality Assurance organization and assure a state of quality compliance.

Rate Negotiable Industry Life Sciences Location Netherlands Term Eleven months Type Contract Ref JO-1701-900354 Posted 33 days ago

Job Description

Purpose of the role

  • Support the growth and development of the Quality Assurance organization and assure a state of quality compliance.
  • Quality and Compliance activities on an operational and tactical level for both production and pre-production. Also required to consult on a strategical level.
  • Back-up Quality Manager PMNL related to Metrology.
Result Areas

Leadership: 
  • Lead or participate in (quality improvement) projects;
  • Develop trainings and train employees with regard to quality and improvement subjects;
  • Coordinate the QA-activities.
  • Sustain and set-up a Quality Assurance organization including adding new (innovative) capabilities to meet changing and increasing customer needs.
Quality: 
  • Generate, review and authorize Quality related documents;
  • Maintain the CAPA (Corrective and preventive actions) system;
  • Maintain the complaint handling system
  • Investigate deviations and NCR’s (non-conformances), by determining the root cause and implementing corrective and preventive action;
  • Analyze data concerning production, processes and the quality management system and propose improvements
  • Release products, processes and equipment based on statistical data;
  • Execute internal and external audits including reports;
Customer Focus: 
  • When requested, accompany Customer and Regulatory Body Auditors.
  • Communicate results of of the KPI’s and quality goals to the Quality Manager.
Team Building:
  • Act as a strong team-builder both with (in)direct reports (when applicable) as well as the peer-group and quality team.
  • Show professional can-do attitude towards the internal as well as the external organization and develop (in)direct reports (when applicable) into the same direction.
Function demands

Education:
  • Bachelor Level or Master Degree in Technical discipline.
Knowledge: 
  • Coaching and Management capabilities
  • Good Manufacturing Practice
  • Quality Management Systems (ISO13485. FDA 21CFR820, MDD 93/42EEC or similar)
  • EO sterilization
  • Cleanrooms/ microbiology
  • Process validation
  • Knowledge of Lean Six Sigma tools and project management
Skills:
  • MUST BE FLUENT IN DUTCH
  • Organized and structured way of working
  • Auditing
  • Good presentation/communication skills in English and Dutch
  • Customer focused
  • Accurate
  • Good judgement; showing business acumen, quality, perspective and problem solving. Thinking in solutions, socially skilled.
Experience: 
  • At least 5 years professional experience.
  • Experience in Leading a Team.
  • Experience in Regulatory and Customer focused organization.
  • Experience in a Pharmaceutical and/or Medical Devices company.
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Peter Jefferys Managing Consultant

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+44 (0)20 7002 0000 Get in touch

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