Product Owner
Location: NetherlandsSIRE® is the market leader in Life Sciences recruitment. We believe the recruitment market needs to gear up in technology and continuous innovation. We like technology, in a Life Sciences market driven on science, we couldn’t stay behind; we drive Recruitment Science. Investing a majority of our turnover in technology enables us to use unique Resource Technologies. By using highly advanced algorithms, we enable our team of Resource & Data Strategists© to maintain the most advanced, detailed and complete Life Sciences network in Europe. This big data enables us to work Reverse Recruitment©: we first analyze the market in-depth before we go out to the market. Because we analyze the whole market, we can compare facts and data. This enables us to do Facts & Big Data Recruitment©, making sure we, or better yet, you find the right career!Our client is a professional Medical Devices organisation, based in Noord-Brabant Netherlands.
Skills:
Experience with System Validation and Business Quality Management Systems (ISO 13485), FDA (21CFR) regulations.
- Make sure that Documents & Record Control applications and related infrastructures are validated;
- Make sure documentation of software validation activities and results for all phases of the software system Life cycle
- Actively interact with Business Process Owners (BPOs);
- Clarifying and linking impact of the new solutions and ways of working including IT, data, people, process solutions;
- Collaborate with IT and EIM to handle selection design and configuration or right technology and data solutions;
- Mapping new solutions and new ways of working, then translate these ways into an implementation plan.
- Minimum 5 years of similar experience in Document & Record Control and Change management field;
- Medical Device experience (ISO 13485);
- Ability and willingness to travel ~20% domestic and international;
- Fluent English.
Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Deinah Bernabela.
The Company
Innovative multinational Medical Device Manufacturer.Role Description
Currently looking for a Product Owner (PO) to join an innovative multinational Medical Device company in Noord-Brabant.Skills:
Experience with System Validation and Business Quality Management Systems (ISO 13485), FDA (21CFR) regulations.
Responsibilities
- Set up lean practices around Quality System Software Controls for related Document & Record Control systems in line applicable policies and procedures;- Make sure that Documents & Record Control applications and related infrastructures are validated;
- Make sure documentation of software validation activities and results for all phases of the software system Life cycle
- Actively interact with Business Process Owners (BPOs);
- Clarifying and linking impact of the new solutions and ways of working including IT, data, people, process solutions;
- Collaborate with IT and EIM to handle selection design and configuration or right technology and data solutions;
- Mapping new solutions and new ways of working, then translate these ways into an implementation plan.
Requirements
- Minimum 5 years of experience in validation of computer systems and systems security and control incl. supervision of a technical professional staff;- Minimum 5 years of similar experience in Document & Record Control and Change management field;
- Medical Device experience (ISO 13485);
- Ability and willingness to travel ~20% domestic and international;
- Fluent English.
Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Deinah Bernabela.
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