Philips-posted 3 months ago
$87,000 - $125,000/Yr
Full-time • Mid Level
Remote • Colorado Springs, CO
5,001-10,000 employees
Merchant Wholesalers, Durable Goods

In this role, you are responsible for creating and executing comprehensive process validation strategies to ensure new products transition seamlessly to production, adhering to quality and regulatory standards. The role executes the full design control process, including validation and design transfer, and ensures accurate and up-to-date quality engineering documentation.

  • Creates and executes comprehensive Design Test Method Validation strategies using statistical tools to ensure seamless transition of new products to production, meeting quality and regulatory standards, working under limited supervision.
  • Handles the entire design control process, from eliciting and validating design inputs to managing verification, validation, and smooth design transfer, ensuring rigorous adherence to regulatory and quality standards.
  • Keeps a check on the drafting and updating of detailed quality engineering documents, including quality plans for hardware, software, and systems, ensuring all documentation is accurate, up-to-date, and compliant with regulatory requirements.
  • Validates critical design inputs such as usability, reliability, performance, manufacturability, and safety, ensuring alignment with both quality standards and regulatory requirements.
  • Guides comprehensive risk management activities throughout the product lifecycle, ensuring potential risks are accurately identified, assessed, and effectively mitigated to uphold product safety and quality.
  • Bachelor's Degree/ Master's Degree in Mechanical Engineering, Electronics Engineering, Science or equivalent.
  • Minimum 2+ years experience in Design Quality Management in Medical Device.
  • Prefer 5+ years of experience with Design, Test Validation, Usability, Reliability, Performance, Manufacturability, Safety, Audit, CAPA.
  • Generous PTO
  • 401k (up to 7% match)
  • HSA (with company contribution)
  • Stock purchase plan
  • Education reimbursement
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