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Quality Manager Netherlands


Requisition Number: n/a

Region: Europe
Country: The Netherlands
City: Hillegom

Responsibilities

We are looking for a Quality Manager PMNL for an18-month contract position and based in our Hillegom offices in The Netherlands 

Position:

We are looking for an energetic, high potential Quality professional that is willing to take on the challenge of redesigning the Quality Management system on a local level. You will be creating something new that you will fully own. Driving and embracing the
change and transferring that positive energy to the team will be key to your
success. This job will provide you with a
great opportunity to grow to the next level in your career as a Quality Manager.

 

Key Responsibilities for the Quality Manager are:

Leadership

  • Provides direction and leadership to the Quality Organization
  • Manages the quality organization focused on quality control (Metrology), quality
    assurance (QA) and quality system improvements
  • Works together with the production department leaders to develop and execute
    long-term strategies and process improvement
  • Implements staff-to-strength and cross-training initiatives to ensure strong morale and retention and to
    provide appropriate challenges to a talented, diverse, and unique creative team
  • Is a key member of the site leadership team

 

Quality

  • Takes ownership of the UQMS within the plant and ensures that it is compliant
    with ISO 13485 and FDA requirements
  • Develops and implements processes to meet customer and internal needs
  • Define, monitor and manage dedicated Quality KPI’s for the organization (with
    Management Team members) and for department individuals
  • Accountable for (final) release of materials and (sterile) products
  • Ensures QMS documents and procedures comply with company and applicable standards
  • Leads the Site Quality Council
  • Management representative according to the requirements defined in the ISO 13485, 21 CFR820
  • Supports audits by customers and regulatory authorities

 

Finance and
Reporting

  • Ensuring execution of agreed budget, implementation of investments in quality organization
  • Report status and results on Analysis of Quality Data on a monthly basis
  • Communicate results of the KPI’s and quality goals to the Plant Management Team and the organization

 

Customer and Supplier relations

  • Actively participates and supports customer visits, programs, and audits
  • Supports the development and presentation of proposals in close collaboration with
    proposal developers and BDMs
  • Effectively communicates Phillips-Medisize value proposition to internal and external
    customers, suppliers and the business community
  • Executes the program according to customer needs and satisfaction
  • Develops and maintains effective working relationships with customer peers

 

Communication:

  • Internal: Frequent communication with Director Quality & Regulatory Affairs,
    Business Development Managers, Plant Quality organization and site
    Project/Program managers, Plant Manager and the rest of the site leadership
    team, Quality and Process Engineering Management, pre-production
    organization and staff. Member of the site Management team
  • External: Customers, suppliers, all other business relations

 

 

 

 

Qualifications - Education & Experience

Knowledge, Skills and Experience:

  • Bachelor or Master Degree in Engineering/science or other technical discipline 
  • Strong understanding of the quality management systems for the medical devices, like: ISO 13485, 21CFR820, 
  • Broad knowledge processes and regulatory requirements
  • Strong understanding of market, customer, technology and emerging trends
  • Strong leadership skills
  • Strong ability to establish and implement structures and processes
  • Strong and effective communication skills, including verbal, written, presentation and negotiation
  • English Language Proficiency at CEBR C level
  • Decision making and prioritization skills
  • Motivated self-starter who is able to manage multiple tasks and challenges
  • Knowledge of Lean Six Sigma tools and Change Execution Management

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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