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Senior Quality Assurance Engineer

2 months ago

Pittsburgh, Pennsylvania, United States Integrated Resources Full time
Position Overview:

The role involves overseeing the quality assurance processes within the product lifecycle, ensuring compliance with industry standards and regulations. The individual will be responsible for:

Key Responsibilities:
  • Developing comprehensive quality, reliability, and Post Market Surveillance (PMS) strategies that encompass all phases of product development.
  • Designing Quality Plans for both hardware and software, ensuring adherence to compliance standards at each project milestone.
  • Validating critical design inputs, including usability, reliability, performance, and safety considerations.
  • Monitoring the implementation of quality and reliability plans, including risk management activities throughout the product lifecycle.
  • Conducting independent assessments of product quality performance and executing post-market analyses to facilitate problem-solving and root cause investigations.
  • Assisting stakeholders during quality system audits and inspections.

Essential Competencies:
  • Quality Management
  • Risk Management
  • Design Controls and Change Management
  • Quality Assurance
  • Quality Engineering
  • Verification and Validation
  • Design Transfer

Job Responsibilities:
  • Independently generating and finalizing Quality Engineering documentation.
  • Executing timely quality engineering tasks, including evaluating quality plans, product designs, and performance data analysis.
  • Providing additional quality engineering support as needed, assisting teams in resolving quality deficiencies.
  • Applying professional expertise and company policies to address various challenges.
  • Possessing a thorough understanding of company products and services.
  • Engaging with supervisors and peers to foster collaboration and present technical information effectively.
  • Addressing diverse issues that require comprehensive analysis and understanding of current market trends.
  • Adhering to operational policies in selecting methods for problem resolution.
  • Advising junior quality engineers and collaborating with key stakeholders, including R&D Engineers, Risk Management professionals, and Regulatory Affairs Specialists.
  • Supporting ongoing project activities within New Product Introduction (NPI) and Sustaining Projects, including quality norm planning and design deliverable reviews.

Qualifications:
  • Bachelor's degree in engineering or a related field.
  • Proficient understanding of global regulations and standards.
  • A minimum of 3 years of relevant experience in a regulated industry, such as medical devices.