Regulated Environment Quality Expert
3 weeks ago
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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