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Senior Quality Engineer


Requisition Number: n/a

Region: Europe
Country: The Netherlands
City: Hillegom

Responsibilities

Position:

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 Senior Quality Engineer
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 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.

Qualifications - Education & Experience

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 years 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.

Qualifications - Skills & Competencies

Offer:

A challenging job in the medical device industry in a
fast changing environment.

Are
you interested in this position and based in The Netherlands? Please send your
CV and application to Heleen Stork, Corporate Recruiter EU. E-mail:
heleen.stork@phillipsmedisize.com


 

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