QA Tester - Medical Devices Testing Job at Katalyst CRO, Loveland, CO

aEF5RVdjVy9sVi9VajJ0blRjWlRFV0FESmc9PQ==
  • Katalyst CRO
  • Loveland, CO

Job Description

Join to apply for the QA Tester - Medical Devices Testing role at Katalyst CRO .

Position: QA Software Tester for Medical Diagnostic Devices.

In this role, you will ensure that software for medical diagnostic devices is rigorously tested, compliant with regulatory standards, and meets high quality and safety standards. This role is essential for maintaining the reliability and efficacy of diagnostic devices in clinical settings.

Requirements include 8-10 years of experience and expertise in relevant medical device regulations (e.g., FDA 21 CFR Part 820, ISO 13485, IEC 62304). You should have experience working in an agile environment to ensure software testing practices comply with these standards and organizational QMS standards.

Key responsibilities:

  1. Document Compliance: Ensure testing QMS and compliance documentation meet regulatory requirements, including test plans, test cases, test reports, and defect tracking.
  2. Test Planning and Design: Develop detailed test plans and comprehensive test cases based on software requirements and regulatory guidelines.
  3. Execution and Verification: Perform manual and automated testing, verify software functionality, performance, and compliance, and ensure proper defect management.
  4. Documentation and Reporting: Maintain accurate records of testing activities and outcomes.
  5. Collaboration and Communication: Work effectively with development teams and stakeholders.
  6. Validation and Verification (V&V): Conduct V&V activities to confirm software meets all specifications.
  7. Training and Development: Stay updated with industry standards and improve testing skills.

Seniority level: Mid-Senior level

Employment type: Contract

Job function: Quality Assurance

Industry: Pharmaceutical Manufacturing

Referrals can increase your chances of interviewing at Katalyst CRO by 2x.

Get notified about new QA Tester jobs in Loveland, CO.

#J-18808-Ljbffr Katalyst CRO

Job Tags

Contract work,

Similar Jobs

University of Miami

Level II Registered Nurse (RN) - Educator Job at University of Miami

 ...Description University of Miami is seeking a Registered Nurse (RN) Educator Level II for a nursing job in Miami, Florida. Job...  ...policies and procedures, including mandatory in-service employee health procedures and federal, state, regulatory, and accrediting agency... 

Refresco

Plant Controller Job at Refresco

 ...boundaries of whats best. Stop and think: how would YOU put our drinks on every table? Position Description The Plant Controller position is accountable for the overall integrity, accuracy and completeness of financial results and safeguarding of plant assets... 

Adobe Systems GmbH

Brand Marketing Director Job at Adobe Systems GmbH

 ...EMPLOYEE ROLEIndividual Contributor The Opportunity Adobes Global Marketing Organization is looking for a dynamic, creative-minded,...  ...dont forget to include your uniquely Adobe experiences and volunteer work.2. Visit the Internal Mobility page on Inside Adobe to learn... 

Rittenhouse Markets

Supermarket Grocery Clerk and Cashier Job at Rittenhouse Markets

 ...Market is seeking qualified applicants to join our team of full and part time Grocery Clerks and Cashiers in our markets. Candidates should...  .... Candidates should have prior experience working in a retail/hospitality environment and possess a strong guest first mentality... 

Workoo Technologies

Work From Home Jobs / Data Entry Clerk - Typing (Remote) Job at Workoo Technologies

About the job Work From Home Jobs / Data Entry Clerk - Typing (Remote) Many thanks you for checking us out. Work form House Data Access (Part-Time). Our company are actually searching for individuals that are actually motivated to work from property as well...