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Senior Quality Assurance Specialist

2 months ago

Pittsburgh, Pennsylvania, United States Comtec Consultants Full time
Position Overview:

As a Senior Quality Assurance Specialist, you will play a crucial role in ensuring the highest standards of quality and compliance throughout the product lifecycle. Your expertise will contribute to the development and execution of robust quality plans for both hardware and software designs.

Key Responsibilities:
  • Develop and implement comprehensive quality, reliability, and Post Market Surveillance (PMS) strategies.
  • Validate critical design inputs including usability, reliability, performance, and safety.
  • Oversee the execution of quality plans and risk management activities, ensuring adherence to established standards.
  • Conduct independent assessments of product quality performance and lead root cause analysis initiatives.
  • Support stakeholders during quality system audits and inspections.

Essential Qualifications:
  • Bachelor's degree in engineering or a related field.
  • A minimum of 3 years of experience in quality assurance within a regulated industry, preferably in medical devices.
  • Strong understanding of global regulations and quality management systems.

Required Skills:
  • Proficient in design controls and change management.
  • Experience in quality engineering, verification, and validation processes.
  • Ability to analyze complex data and provide actionable insights.
  • Excellent communication skills for effective collaboration with cross-functional teams.

Job Responsibilities:
In this role, you will independently produce and complete essential quality engineering documentation. You will be responsible for:
  • Assessing quality plans and product designs.
  • Reviewing test data and analyzing market feedback.
  • Leading quality problem-solving initiatives and root cause analyses.
  • Advising junior quality engineers and collaborating with various stakeholders, including R&D and Regulatory Affairs teams.

As a fully qualified quality engineer, you will leverage your expertise to guide project teams in addressing quality-related inquiries and ensuring compliance with operational policies. Your contributions will be vital in maintaining the integrity and reliability of our products.