Consultant QA-RC (m/f/d)

Ballaigues  ‐ Vor Ort
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Beschreibung



Consultant QA-RC (m/f/d)

Reference: -en
Start: asap
Duration: 8 MM+

Main tasks:
  • Support the maintenance/update/remediation of Endodontics Technical Dossiers (TD), Technical Files (TF) and Design History Files (DHF) according to applicable international regulations & standards (e.g. EU MDR)Assess impact of (and act upon) manufacturing or design changes or non-conformities on TF, TD & DHF
  • Support implementation of appropriate controls to ensure Endo Product records are maintained/archived/updated to meet applicable record retention and regulatory requirements
  • Support Endodontic product change orders and new product development from a Product Compliance perspective, from feasibility up to commercialization and throughout the product lifecycle
  • Work closely with multifunctional Product Development teams to ensure compliance with design control, safety, functional goals requirements with a patient-related focus in accordance with all applicable requirements (i.e. Corporate, Consumables Group, FDA, MDD, MDR, etc.)
  • Review and approve deliverables generated during new product development or change controls for accuracy and compliance (design inputs, V&V, design outputs, marketing claims, risk management, labelling requirements, rationale etc.…)
  • Interact with Regulatory Specialists to identify product classification and regulatory pathways for certifications (FDA, CE, INMETRO, etc.)
  • Provide expert guidance to R&D for applicable standards and regulations. Interact with Clinical for BSA and CED maintenance
  • Ensure conformity of all product labelling associated to the product (UDI, IFU, Brochure, etc.)
  • Pilot risk activities according to applicable requirements (i.e. ISO 14971). Gather the PMS data to support a semi-quantitative analysis
  • Maintain Risk Management Reports up to date
  • Support sites, group, corporate & regulatory bodies’ audits & inspections regarding TD, TF and DHF
  • Support the impact assessment of regulatory and standards changes, CAPAs & NCs on the TD, TF & DHF
  • Coordinate with the quality team of the manufacturing sites to correctly document design transfer, process validation, manufacturing flow chart, SDS …)
  • Elaborate technical files/dossiers and GSPR


Main qualifications
  • M.S. in Biomedical Engineering or Mechanical Engineering
  • Experience within medical devices industry in Quality Assurance and/or Regulatory Affairs. Experience in Dental Industry is a plus
  • Experience within international multi-disciplinary R&D or QA/RA organizations in the area of medical device design control and regulations (21 CFR part 820, 93/42/EC Directive, EU Regulation, SOR 98/282, MHLW M.O. 169), quality management standards (ISO 13485), and risk management (ISO 14971)
  • Experience with the impact assessment and the integration of Manufacturing or Design Change Controls into a Technical Dossier; as well as 
  • Experience in Technical Dossier compilation for submission to notified bodies
  • Excellent knowledge of Product Technical Dossier structure to comply to MDR
  • Knowledge of international standards requirements according to IEC 14457, ISO 14971, ISO 13485
  • Excellent communication and writing skills in English (C1); French and/or German would be a plus
  • Strong team player with the ability to build productive relationships in a dynamic international environment
  • Autonomous and independent decision-taker
  • Result-orientation combined with conscientiousness in execution
  • Excellent knowledge of office Suite including OneNote


Main advantages:
  • Interesting tasks in an innovative company



About us:
With over 15 years of experience in the pharmaceutical and chemical industry as well as in biotechnology and medical engineering, we know the key contacts at companies that are recruiting for challenging jobs with real potential. The current high demand for staff has opened up exciting opportunities for dedicated experts who want to develop professionally and to further their careers. As recruitment specialists with an international network of contacts, we can offer you decisive advantages – completely free of charge. Register with us and reap the benefits of interesting job offers that match your skills and experience.

My contact at Hays:

My contact person:
Laura Feig

Referencenumber:


Make contact:
Phone:
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Start
ab sofort
Dauer
8 MM+
(Verlängerung möglich)
Von
Hays AG
Eingestellt
06.05.2022
Ansprechpartner:
Hays AG
Projekt-ID:
2379691
Vertragsart
Freiberuflich
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