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Quality Assurance Engineer

2 months ago

Lafayette, Colorado, United States Planet Pharma Full time

Job Overview:

Our client, Planet Pharma, a prominent player in the Medical Device sector, is in search of a junior-level Quality Assurance Engineer. This role involves the formulation of strategies and the execution of verification and validation tasks for software and systems, ensuring that the innovative medical products align with user requirements and adhere to quality and reliability benchmarks.

Key Competencies:

  1. Experience in a regulated industry (such as Aerospace, medical devices, academic laboratories, etc.),
  2. Familiarity with medical device verification and validation processes,
  3. Understanding of software design, development, debugging, and testing methodologies.

Core Responsibilities:

  • Develop and manage plans, timelines, and equipment necessary for testing, including the design of examination tools, fixtures, and phantoms.
  • Analyze data and identify modifications needed in testing apparatus, procedures, manufacturing workflows, or new testing criteria.
  • Utilize and apply technical standards, principles, theories, concepts, and methodologies regularly.
  • Oversee the verification and validation of new or modified products, including the creation of plans, protocols, and reports for conducted tests.
  • Design, develop, and maintain testing software.
  • Ensure that testing equipment is operational and calibrated as required.
  • Coordinate and supervise the testing of products and equipment at external testing facilities.
  • Establish and enhance test tracking, monitoring, and data recording systems.
  • Provide solutions to a range of technical challenges of varying complexity.
  • Engage in all stages of product development as necessary, including reviewing requirements, design, usability, risk assessment, and defect analysis.
  • Design, implement, and/or execute automated testing procedures.
  • Identify and apply process enhancements.
  • Participate in defect tracking and evaluation.
  • Troubleshoot, debug, maintain, and support existing products.
  • Effectively communicate findings, issues, and solutions to project teams and stakeholders.
  • Collaborate and maintain strong working relationships with team members and stakeholders.
  • All activities must comply with the Quality System.
  • Perform duties in accordance with environmental, health, and safety regulations.
  • Other responsibilities as assigned.

Qualifications:

  • Bachelor's Degree in an Engineering discipline and 1-3 years of relevant experience.