Quality V&V – area R&D

By | Februar 14, 2021
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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&DImportante 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.

Expected salary: €35000 – 45000 per year

Location: Provincia di Verona

Job date: Sun, 14 Feb 2021 08:21:44 GMT

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