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Manager Quality NL


Requisition Number: n/a

Region: Europe
Country: The Netherlands
City: Hillegom

Responsibilities

Quality Manager PMNL

A full time
position based in our Hillegom offices
in The Netherlands  

 

Position:

The
Quality manager leads the growth and development of the Quality Organization in
the plant and assure a permanent state of quality compliance. Improve existing
capabilities and add new (innovative) capabilities to meet changing and
increasing customer needs focused on compliance. Set up the quality
organization to support smooth product/project transfer into the OPS
organization and assure successful ramp up.

 

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) and quality assurance (QA)

·       

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

 

Quality

·       

Takes ownership of the UQMS
within the plant

·       

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, ISO 9001

·       

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,
Quality and Process Engineering Management, pre-production organization and
staff. Member of the site Management team

·       

External: Customers, suppliers,
all other business relations

 

 

·       

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 - Education & Experience

Knowledge, Skills and Experience:

·        Bachelor or Master Degree in Engineering or other technical discipline 

·        Strong understanding of the quality management systems for the medical and primary pharmaceutical packaging’s, like: ISO 13485, 21CFR820, ISO15378.

·        Broad knowledge processes and regulatory requirements

·        Strong understanding of market, customer, technology and emerging trends

Qualifications - Skills & Competencies

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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