philips

QMS Manager

Posted Oct 10, 2017
Project ID: PHILJP00015757
Location
Eindhoven , Noord Brabant
Duration
a year (Oct 2, 2017 - Dec 31, 2018)
Hours/week
40 hrs/week
Payrate range
71 - 81 €/hr
Functie = QMS Manager
Omschrijving = zie bijlage
Must have = Business Process Expert (in the area of Document & Record and Change control)Nice to have items = Project management
Benchmark max rate = 81,81 euro.
Two reasons:
•  I have an employee out of office due to illness (for Q4/2017)
•  There is a project that requires temporary additional support (for 2018)

Your challenge
We are looking for an enthusiastic Business Process Expert (BPE), contingent worker in the area of Document & Record and Change control with experience in Business Quality Management Systems (ISO 13485) and FDA (21CFR) regulations within an international environment being a Philips expert in specific process.

Develop, implement and drive continuous improvements of the standardized business capabilities for his/her expertise area. Process custodian and ensures adoption of proven practices. Capture learnings and actively share success within your network.

Your responsibilities
•  Execute capability maturity assessment, translate these into business requirements and prioritize
•  Collaborate in business transformations to provide expert support in diagnosis of processes within area of expertise, suggest proven practice solutions and ensure implementation of the suggested processes
•  Collaborate with IT and EIM to drive selection design and configuration of right technology and data solutions
•  Lead or support process implementation projects and ensure processes are implemented as designed
•  Mapping new solutions and ways of working and translate these into an implementation plan. Decision needed on project management resource
•  Being a change agent by clarifying the linking impact of the new solutions and ways of working including the IT, data, people, process solutions.
•  Facilitate learning, provide process training (competency development) and prepare end user documentation.
•  Provide expert support in diagnosis of processes within area of expertise to perform process gap analyses, suggest enforce the selected best practice solutions and ensure compliance with the standardized suggested processes
•  Continuously monitor process performance, analytics and identify opportunities for improvement (level 4-7)
•  Collect and review process change and improvement proposals from the organization, bring forward relevant change proposals to the Business Process Owners (BPOs), support local improvements where necessary
•  Actively interact with other BPE’s to share knowledge on improvement practices

Your team
You are part of the Philips Q&R – PQMS capability and you will be part of the Center of Excellence – Controlled Documented Information (CoE CDI) team existing of 10 persons dealing with activities like Quality Management, System Validation, Training, CAPA, Management Review and Change, Document & Record Control.

Our offer
We welcome you to a challenging, innovative environment with great opportunities for you to explore. The offer is based on a temporary contract (1 fte) until end of 2018.

We are looking for
Our ideal candidate has the following profile criteria:
•  Has wide-ranging experience, uses professional concepts and company objectives to resolve complex issues in creative and effective ways.
•  Distinguished by additional specialized knowledge in breadth and/or depth, as well as record of success in relevant discipline. Viewed as an expert in the field. May have a leadership role. Having wide-ranging experience, uses professional concepts and company objectives to resolve complex issues in creative and effective ways. Has expert level knowledge of company products and services.
•  Regularly interacts with senior management or executive levels on matters concerning several functional areas, divisions, and/or customers. Requires the ability to change the thinking of, or gain acceptance from, others in sensitive situations, without damage to the relationship.
•  Master’s degree with ? 5 years of related experience.
•  Minimum of 6 years of related experience in Document & Record Control and Change management field
•  Minimum of 4 years of experience in Business Quality Management Systems (ISO 13485) and FDA (21CFR) regulations
•  Familiarity with Document and Change Management System tools
•  Experience running effective process improvement projects
•  Knowledge of Applicable regulations (Quality System Regulations) and regulatory requirements
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