Quality Assurance Engineer

4 days ago


Fort Atkinson, Iowa, United States PSC Biotech Full time
PSC Biotech OverviewPSC Biotech is a leader in life sciences services, driven by a passion for excellence in healthcare product development, manufacturing, and distribution. Our global presence ensures seamless collaboration across multiple locations, empowering us to deliver unparalleled results for our clients.

We prioritize employee growth, offering coaching, development opportunities, and a supportive work environment that fosters creativity and innovation. Our team of experts is dedicated to making a meaningful impact in the industry, pushing boundaries, and achieving remarkable success.

The Position

This role requires a seasoned Quality Engineer with a deep understanding of validation processes and procedures. As a critical member of our project success team, this individual will ensure compliance with industry regulations and standards, delivering exceptional results and supporting our clients' achievements.

Responsibilities Include:
  • Providing thorough quality review and approval of validation lifecycle documentation.
  • Ongoing technical guidance and expertise to ensure compliance with industry standards and regulations.
  • Reviewing and approving specified documentation, including technical specifications, vendor-supplied test results, design qualification, test plans, RTM, changes, and exceptions.
  • Guidance on interpretation and application of specified requirements.
  • Effective communication of project updates and milestones with stakeholders.
  • Identification of errors, risks, and potential documentation issues, ensuring accuracy and compliance in required documentation processes.


Requirements
  • Bachelor's degree in a scientific or engineering discipline.
  • 5+ years of quality engineering experience in the pharmaceutical and/or medical device industry.
  • Strong understanding of regulatory requirements.
  • Excellent analytical and problem-solving skills.
  • Ability to work independently and lead validation projects.


CompensationWe offer a competitive salary range of $95,000-$130,000 annually, depending on experience, along with a comprehensive benefits package, including medical, dental, and vision coverage, 401(k) matching, education assistance, pet insurance, and discounted fitness memberships.

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