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Senior Quality Assurance Engineer

2 months ago

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

The role of the Quality Assurance Engineer III is crucial in ensuring the integrity and reliability of products throughout their lifecycle. This position involves working closely with various stakeholders to uphold the highest standards of quality and compliance.

Key Responsibilities:

  • Develop and implement comprehensive quality, reliability, and Post Market Surveillance (PMS) strategies that encompass all phases of the product lifecycle.
  • Assist in the formulation of Quality Plans for both hardware and software, ensuring adherence to quality and compliance benchmarks at every milestone.
  • Evaluate essential design inputs, including usability, reliability, performance, and safety, to ensure product excellence.
  • Oversee the execution of quality and reliability plans, risk management activities, and all design-related tasks throughout the product/system lifecycle.
  • Conduct independent assessments of product quality performance and analyze post-market product quality to facilitate effective problem-solving and root cause analysis.
  • Support stakeholders during quality system audits and inspections, ensuring compliance with established standards.

Required Skills:

  • Expertise in Quality Management
  • Proficient in Risk Management
  • Knowledge of Design Controls and Change Management
  • Experience in Quality Assurance and Quality Engineering
  • Familiarity with Verification and Validation processes
  • Understanding of Design Transfer methodologies

Job Duties:

  • Independently generate and finalize Quality Engineering documentation.
  • Execute timely quality engineering tasks, including evaluating quality plans, product designs, and performance data analysis.
  • Provide additional quality engineering support as needed, assisting teams in addressing quality deficiencies.
  • Apply professional expertise to resolve a variety of issues in accordance with company policies.
  • Possess a thorough understanding of company products and services.
  • Engage regularly with supervisors and peer groups, requiring effective collaboration and presentation skills.
  • Analyze diverse product-related issues, considering various factors and current business trends.
  • Adhere to operational policies in selecting appropriate methods for problem resolution.
  • Act as a mentor to junior quality engineers.
  • Collaborate with key stakeholders, including R&D Engineers, Risk Management engineers, and Regulatory Affairs Specialists, to fulfill quality responsibilities.
  • Support ongoing project activities within New Product Introduction (NPI) and Sustaining Projects, including quality norm planning and design deliverable reviews.

Education and Experience:

  • Bachelor's degree in engineering or a related field.
  • Comprehensive knowledge of global regulations and standards.
  • A minimum of 3 years of relevant experience in the medical device or regulated industry.