Senior Quality Engineer

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

Rate Negotiable Industry Life Sciences Location Netherlands Term Thirteen months Type Contract Ref JO-1611-899137 Posted 62 days ago

Job Description

The Senior Quality engineer can support the growth and development of the Quality Assurance organization at PMNL and assure a permanent state of quality compliance. Quality and Compliance activities from the Senior Quality engineer are on an operational and tactical level. For both the production and pre-production organization within Phillips-Medisize it is also required to consult on a strategical level. The Senior Quality Engineer is if necessary a back-up for the Quality Manager PMNL related to Metrology.             
 
Key Responsibilities for the Operations Manager are:

  • Leadership & Production strategy
  • 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.
Communication:
  • Internal: All departments of Phillips-Medisize.
  • External: Global organization, customers and suppliers.
Knowledge, Skills and Experience:
  • Bachelor Level or Master Degree in Technical discipline
  • 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
  • Organized and structured way of working
  • Good presentation/communication skills in English and Dutch
  • Customer focused and accurate
  • Good judgement; showing business acumen, quality, perspective and problem solving.
  • Thinking in solutions, socially skilled.
  • At least 5 year professional experience
  • Experience in Leading a Team and Auditing
  • Experience in Regulatory and Customer focused organization
  • Experience in a Pharmaceutical and/or Medical Devices company.
#LI-PJ1 #LI-15

Peter Jefferys Managing Consultant

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+44 (0)20 7002 0000 Get in touch

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