Regulated Environment Quality Expert

3 weeks ago


Manchester, New Hampshire, United States DEKA Research & Development Full time

Job Description

We are seeking an experienced Quality Engineer-Project Lead to join our team at DEKA Research and Development. As a key member of our quality team, you will be responsible for leading our quality initiatives in a fast-paced medical device research and development environment.

The successful candidate will have a proven track record of driving quality improvements, collaborating with cross-functional teams, and ensuring compliance with regulatory requirements.

About the Role

  • Develop and implement quality systems and procedures, including risk management, design transfer, and regulatory submissions.
  • Collaborate with design teams to ensure compliance with regulatory requirements and company standards.
  • Develop and implement training programs for quality-related topics.
  • Participate in internal and external audits, including ISO 13485:2016 and 21 CFR 820.

Requirements

  • Bachelor's degree in an engineering discipline or related STEM field.
  • Minimum 5-8 years of experience in quality engineering in a regulated environment, preferably in medical devices.
  • Strong attention to detail and excellent verbal and written communication skills.

Estimated Salary: $130,000 - $190,000 per year, depending on experience and qualifications.

About DEKA Research & Development

At DEKA Research and Development, we value innovation and collaboration. Our team is passionate about creating life-changing products and improving people's lives through thoughtful engineering, design, and manufacturing.



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