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Senior QA Engineer

Remote: 
Full Remote
Contract: 
Full time
Experience: 
Mid-level (2-5 years)
Work from: 
Poland

Offer summary

Qualifications:

Experience in medical device regulatory compliance, Knowledge of ISO standards and medical device development, Strong communication skills in English.

Key responsabilities:

  • Maintain quality management system procedures
  • Analyze and improve system effectiveness
  • Ensure compliance with specifications and regulations
  • Provide regulatory guidance throughout product lifecycle
  • Collaborate with teams on regulatory strategies
Chabre logo
Chabre Management Consulting Scaleup https://www.chabre.pl/
51 - 200 Employees
About Chabre
Chabre IT Services is a global professional IT services provider, building long-lasting relationships with Enterprises. We specialize in the delivery of tailor-made solutions, smart outsourcing and team leasing services. We are smart IT boutique with unique knowledge, which will deliver your ideas into reality. We can proudly say that:• As an Experts in our field, we offer the highest quality of services at every stage of Software Development Life Cycle to help you save time and optimize costs.• We are flexible in selecting the best approach for your IT Strategy – IT Outsourcing, Team Leasing, Try and Hire and IT Project Delivery.• We conduct our projects using Scrum based approach. You will track the progress of your projects in a 2 weeks cycles.• We understand the needs of our Clients and effectively advice to ensure the best quality of your IT business solutions. _Our purposeChabre was establish to help our Clients with digital transformation. We deliver the best people and the best projects for enterprise companies around the globe._Our missionOur mission is to exceed expectations of our Clients and Employees._Our visionBusiness requires calmness and trust. Our vision is to deliver professional digital projects and be a trusted partner for our Clients and Employees.
See more Chabre offers

Job description

Working As a Senior QA Engineer, You Will

  • Create and maintain quality management system procedures to support regulatory and quality compliance
  • Monitor, analyze, and improve the effectiveness of the quality management system
  • Develop corrective actions, solutions, and improvements
  • Support the D&D processes and ensure the requirements of specifications, standards and regulations are complied
  • Provide regulatory advice and guidance throughout the complete product lifecycle: Requirements, Design, Verification & Validation, Commercialization and Maintenance
  • Collaborate with other teams and customers to develop and implement regulatory strategies and pathways for medical devices
  • Conduct internal audits and ensure timely follow through on resolution of related audit findings
  • Participate in the evaluation and approval of suppliers
  • Provide quality and regulatory related trainings

About Chabre IT Services

Chabre IT Services is a global professional IT services provider, building long-lasting relationships with Enterprises. We specialize in the delivery of tailor-made solutions, smart outsourcing, try&hire, and success fee services. We are a smart IT boutique with unique knowledge, which will deliver your ideas into reality.

About Our Client

Our client is one of the leading companies in the medical laboratory testing sector. They have been operating since 1992 and offer a wide range of diagnostic tests for patients, companies and medical facilities. They have modern laboratories in Warsaw, Katowice, Kraków, and other places in Poland. They work on improving the medical equipment, provide online medical consultations, and have a platform where patients can manage their test results.

Qualifications

  • Working knowledge as Senior QA Engineer having contact with medical device regulatory or other regulated business (e.g. automotive, aerospace, etc.)
  • Proven practical experience with medical device standards such as ISO 13485, ISO 14971, IEC 62304 & IEC 62366
  • Considerable knowledge of medical device software and/or hardware development and production
  • Excellent interpersonal, written, and verbal communication skills (English)
  • Ability to represent the company during audits (2nd part and 3rd part)
  • Ability to work independently and effectively without supervision
  • Shows an organization & business awareness, including customer focus
  • Capability to solve complex problems
  • Ability to demonstrate the process behind the thinking

We offer

  • Rate to 160,00 PLN/h + VAT
  • Remote work
  • Subsidy for peripherals in the amount of 500,00zł
  • Working tool (MacBook Pro or Lenovo Legion 5)
  • Co-financing of courses related to the position
  • Benefits: MultiSport, Medicover

Required profile

Experience

Level of experience: Mid-level (2-5 years)
Industry :
Management Consulting
Spoken language(s):
English
Check out the description to know which languages are mandatory.

Hard Skills

Medical Device DirectiveMedical DevicesISO 14971 StandardMac OSCustomer CentricityIEC 61508 StandardMedical SoftwareInternal AuditingIEC 61850ISO 13485 Standard

Other Skills

  • Verbal Communication Skills
  • Supervision
  • Organizational Awareness
  • Organizational Skills
  • Analytical Skills
Are you interested?

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