Job title: Quality V&V – area R&D
Company: Page Personnel
Job description: The Quality Engineer is the liaison between Quality Assurance Area, Research & Development (R&D) Area and Regulatory Affairs Area during the Design & Development phase of products. He/she must guarantee that Design & Development activities are conducted in compliance with internal procedures and in conformity with standards, directives and laws applicable to the Organization. It works strictly in contact with Design & Development Area promoting specific activities like Risk Management process, design verification, design validation and final release. He/she will interact with Consultants, Subsidiaries, Competent Authorities, Notified Bodies, Distributors, External laboratories and suppliers. Good time management skills and relationship skills are necessary in this role. Main responsibilities:
- Cooperate with internal departments during the Product Development Process to permit: regulatory release (CE Mark, FDA approval) for new products (standard products, small series, custom products), product modifications
- Manage (i.e. promote, coordinate and document) the Risk Management activities during the Product Development Process, in relation to product modifications and during post-marketing surveillance
- Manage (promote, coordinate and document), in cooperation with R&D, Marketing, Medical Science and Clinical Affairs, the design validation about new products
- Prepare and maintain the Technical File documentation (e.g. Device Master File) for new products or modified products and cooperate with Regulatory Affairs Area to prepare regulatory submissions (e.g. 510K pre-market notifications), and
- Prepare and maintain Summary Technical Documentation (STED) for regulatory purposes
- Support all the regulatory pre- and post-market activities related to technical aspects
- Support the R&D area to formalize:
- development plan;
- development phase gate documentation;
- design verification documentation;
- design validation.
- Usability Engineering documentation
- Conduct or support internal audits to the R&D area.
- Support the preparation and review of product technical & marketing sheets
- Contribute to the preparation of Instructions for use of new or modified products.
- Promote improvement initiatives, including the implementation of corrective and preventive action.
- Support Customer Services and the Tender office by supplying product related declarations requested from customers or Authorities
- Provide support during audits/inspections carried out by Notified Body or Regulatory Competent Authorities to achieve and maintain facility certifications.
- Quality V&V – area R&D
- Importante multinazionale settore biomedicale
Education: Technical degree/ Master’s Degree in Engineering with an electronic background Business skills:
- 2-3 years in similar position in an Active Medical Device Company
- Good knowledge of technical standards as IEC 60601-1 series, IEC 62304 are fundamental requirements
- Knowledge of relevant regulations (European MDD, MDR, FDA Guidance, ISO 13485, ISO 14971, EN 62366, IEC 62304, etc.).
Languages: Fluent English, both written and oral Computer Skills: Very good knowledge and ability to use standard office applications Other Skills
- Methodical and critical thinking.
- Excellent organizational and project management skills.
- Problem solving skills and „can do“ attitude
- Ability to work precisely according to procedures, rules and regulations
- Adherence to timelines and result oriented attitude
- Orderliness and attention to detail
- Analytical approach to resolve complex issues
- Ability to work in team and autonomously
- Accountability for the assigned tasks
- Travel 10-15%
Importante multinazionale settore biomedicale
Ottima opportunità di carriera.
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Job date: Sat, 13 Feb 2021 23:02:24 GMT
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