DEKA Research & Development
DEKA is one of the leading research and development companies in the country and is the birthplace of some of the most innovative and life-changing products of our time$1. .$1
501 - 1000
Project Quality Engineer
2 days ago
🏢 In-office - Manchester
DEKA Research & Development
DEKA is one of the leading research and development companies in the country and is the birthplace of some of the most innovative and life-changing products of our time$1. .$1
501 - 1000
Description
• Provide Quality Leadership on a medical device research and development team. • Work with design team leads and project management for compliance with SOPs and regulations. • Use experience in product development to guide new products. • Identify compliance with applicable standards and regulations. • Lead Risk Management activities in accordance with ISO 14971:2019. • Support risk analysis during product anomaly reviews. • Lead investigations including root cause identification and corrective actions. • Ensure accurate documentation for communication with partners and regulatory bodies. • Evaluate and approve proposed design changes. • Participate in internal and external audits.
Requirements
• Bachelor’s degree in an engineering discipline • A degree in a related STEM discipline (Physics, mathematics, etc.) may be considered with sufficient professional experience. • Minimum 5-8 yrs. of experience in Medical Device Quality Engineering • Experience in new product development strongly preferred. • Experience with compliance, with applicable standards and regulations such as 21 CFR 820, ISO 13485:2016, and ISO 14971:2019 required. • Experience supporting EU fielded product is a plus. • Experience developing and leading quality system procedures required. • Experience with direct responsibility for Risk Analysis and Design Transfer is preferred. • Experience supporting regulatory body submissions preferred. • Experience participating in internal and external audits preferred.
Apply Now
