Senior Quality Specialist
7 days ago
Quality Engineer Project Lead Role
We are seeking a seasoned Quality Engineer Project Lead to provide quality leadership for our dynamic medical device R&D team. The successful candidate will be responsible for ensuring on-going compliance with applicable SOPs and regulations.
Main Responsibilities:
- Collaborate with cross-functional design teams and project management to determine the best approach for compliance with 21 CFR 820 and ISO 13485:2016.
- Provide guidance and assistance in product development using experience in product development or production of medical devices.
- Ensure compliance with applicable standards and regulations through experience with engineering and technology.
- Participate in and lead Risk Management activities in accordance with ISO 14971:2019.
- Lead investigations, including root cause identification, corrective actions, and verification of effectiveness.
Requirements:
- Bachelor's degree in an engineering discipline.
- Minimum 5-8 years of experience in Medical Device Quality Engineering.
- Experience with compliance, applicable standards and regulations, and new product development.
About DEKA Research & Development
DEKA Research & Development is a cutting-edge company that takes innovation and technology to the modern age. Our team of professionals strives to make a difference every day through thoughtful engineering, design, and manufacturing.
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