Sr. Development Quality Engineer

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Boston, MA
$95,000 - $115,000
Job Type
Direct Hire
Feb 06, 2018
Job ID
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Sr. Development Quality Engineer
  • Individual contributor with comprehensive knowledge in specific area.
  • Ability to lead and execute, in a timely manner, highly complex or specialized projects
  • May make significant departures from traditional approaches to develop and implement solutions.
  • Works closely with development/manufacturing/quality engineering to establish and ensure compliance with the quality system.
  • Ability to act on their desire to make a difference, partner with others and put ideas into action.
  • Actively engaged in a work culture that is team oriented, fast paced, accountable and progressive.
  • Evaluates quality processes and system standards to ensure compliance with company standards and governmental regulatory requirements.
  • Investigates/troubleshoots validation problems for product performance and /or equipment processes.
  • Conducts statistical analysis of test data and process anomalies
  • Writes, reviews approves and/or executes documentation for new and current verification & validation procedures and technical reports related to equipment, product and/or processes.
  • Ensures company's adherence to the established Quality System and GMP/ISO standards, including management of new product Design History Files.
  • Works with Engineering, Marketing, Manufacturing, Clinical and Regulatory to establish measurable, valid product requirements.
  • Aides in definition / validation of test equipment, as required to accomplish quality responsibilities.
  • Develops and documents test plans, procedures, protocols and reports.
  • Executes and / or reviews tests according to various protocol requirements.
  • Assists in completion of Risk Management (including cybersecurity) activities, including Risk Analysis, Use & Design FMEA, Plans and Reports.
  • Works with R&D engineering to devise Design Verification and Validation plans for products based on performance specifications and risk analysis.
  • Analyzes and communicates product test results / conformance to specifications and standards.
  • Conducts technical and statistical investigations concerning optimization to specification and compliance to specification.
  • Assists in definition and completion of in vitro testing including applicable animal studies.
  • Assists in defining and measuring process capability, process controls, and process validation; assists in definition of Critical to Quality (CTQ) parameters.
  • Aides in definition of supplier quality specifications, sampling plans, and vendor qualification.
  • Assists in specifications and testing of sterilization methods.
  • Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day), Keyboard use (greater or equal to 50% of the workday)
  • 10 % of the Time
Identifier: $NEER $Medd