Job Description

Choose a job you love, and you will never have to work a day in your life. — Confucius

Sr. Quality Engineer

  • Job Tag: #LI-KF1
  • Posted: June 26,2019

Located in the St. Paul area.

Responsibilities

  • Provide input to design and manufacturing documentation including material specifications, drawings, inspection procedures, and manufacturing procedures, to ensure that the resulting products can be adequately manufactured and tested.
  • Identify requirements for verification and validation and reliability testing.
  • Develop product Design History Files (DHR), Technical Files, Device Master Records (DMR), and FMEAs.
  • Provide quality review of process validation and test method validation protocols and reports.
  • With Regulatory, ensure all documentation meet the requirements of Regulatory Filings and Technical files for CE filings.
  • Provide statistical guidance to test protocols/reports and ensure that the testing is sufficient to meet regulatory requirements and quality objectives.
  • Plan schedule and complete projects in an aggressive sense of urgency manner consistent with corporate objectives.
  • Provide quality review of manufacturing documentation, including following lot release procedures for shipping product to customers.

Desired Skills and Experience

  • Requirements:
  • Education- Master’s or Bachelor’s Degree in engineering or related field
  • 5 years minimum experience in medical device or pharmaceutical industry
  • Ability to understand specifications, tolerances, and units and use standard measurement equipment
  • Familiar with QC sampling plans
  • Knowledge of FDA, GMP, and ISO 13485 compliance requirements
  • Familiar with the product life cycle of medical device development

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