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Quality Compliance Manager EU


Requisition Number: n/a

Region: Europe
Country: The Netherlands
City: Hillegom

Responsibilities

The Quality Compliance Manager
Europe will have a
 full time position with a scope on our
European facilities and will be 
based in our Hillegom offices in The
Netherlands
 .

Position:

The Quality Compliance Manager Europe provides Quality Assurance input with the main focus on process
improvements and improving operational quality as well as the speed of the
quality aspects of the NPI process and supports region Quality departments on
quality assurance and continual improvement projects to assure compliance with
FDA regulations, corporate directives, ISO 13485 standards and Company
strategies.

Key Responsibilities for
the Quality Compliance Manager are:

 Quality

  • Establish, maintain and improve regional quality KPIs, including TCOQ metrics
  • Assist in site regulatory compliance readiness activities
  • Active participation in defining activities to assure compliance to all Internal
    Policies and Procedures as well as to all external standards (QSR, ISO
    13485 and the MDR/IVDR)
  • Assist and participate in the preparation of quality assurance specifications and
    procedures to implement such methods
  • Perform audits, surveys and initiation of corrective action plans as assigned
  • Support annual training to the requirements of QSR, ISO 13485, Quality Training and
    the MDR/IVDR for all appropriate personnel as necessary

  1. Improvement

  • Provide Quality Engineering support as needed for technical problem solving and
    root cause analysis and trending
  • Analyze and report quality/monitoring data with a strong focus on process /QMS
    improvement
  • Analyze problems occurring in the processing, fabricating, assembling and testing
    phase of products and implements structural corrective actions to prevent
    reoccurrence
  • Participate in CAPA meetings to ensure adherence to requirements and closure of CAPAs
    as assigned
  • To ensure that the NPI process is compliant with quality requirements and
    functioning in a state of the art manner.
  • Ensure that the validation process is developed, adhered to and implemented across
    all sites in the European region

 Project Management

  • Lead the implementation of process improvement projects
  • Lead the development of operational quality and NPI procedures to assure
    alignment with current MDR/IVDR, GMP/QSR, and ISO requirements
  • Assure that all activities in the area of equipment, process and software
    validations are continually improved and meet EU/FDA and International
    regulatory requirements

 Finance & Reporting

  • Report status and results on Analysis of Quality Data and TCOQ
  • Implement and initiate effective solutions in order to decrease the TCOQ and the PCOQ
  • Dedicated focus on the identification, management, and sustainment of continual improvement efforts
    that drive Total Costs of Quality (TCOQ)

 Communication:

  • Internal: Quality & Regulatory Affairs, Plant Quality organization and other,
    Quality and Process Engineering Management, pre-production organization and
    staff.
  • External: Customers, suppliers,
    all other business relations

 

 

Qualifications - Education & Experience

Knowledge, Skills and Experience:

  • A bachelor’s degree in science or engineering or a related field and/or a combination of practical and educational experience in the medical device industry
  • Competent working knowledge of EU, US, and International standards for medical devices.
  • Strong understanding of the quality management for the medical and drug delivery devices (e.g. ISO 13485, 21CFR820)
  • Broad knowledge of operational processes and technical quality requirements for both software and hardware
  • Strong understanding of market, customer, technology and emerging trends
  • Strong understanding of quality improvement and statistical tools
  • Proficiency in Microsoft Word, Excel and Outlook, Visio, Power Point Visual Basic, Access, and Mini-Tab or other comparable statistical analysis software application
  • Ability to write reports, business correspondence, and procedure manuals 
  • Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form.
  • Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists
  • English language Proficiency on C1 level 
  •  Proven project management skills; able to complete technical projects with minimal supervision
  • Strong organizational, project management and communication skills 
  • Ability to perform varied tasks in a disciplined, consistent manner
  • Able to work in a team environment
  • Three to five years of experience in engineering with the application and implementation of (MDD/GMP/QSR/ISO) regulations 
  • Lean Six Sigma Green Belt or higher preferred. Experience with alternative Quality related tools (e.g. D and P, FMEA, QFD, SPC, Risk Analysis, DOE, and TQM) considered a plus.

 

 

Qualifications - Skills & Competencies

Are you interested in this position and based in The Netherlands? Please send your CV and application to Harald de Vries, HR Manager NL. E-mail: harald.devries@phillipsmedisize.com

*LI-POST


 

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