BioTalent
Quality Assurance Engineer for Medical Devices - Pre-Market Opportunities
A rapidly expanding medical device company, specializing in pre-market Class II/III products, is on the lookout for a dedicated Quality Assurance Engineer. This pivotal role will contribute to the development and regulatory approval processes of groundbreaking medical technologies, ensuring that our design, development, and risk management activities comply with the required standards prior to market release.
Key Responsibilities:
Deliver quality engineering expertise throughout the product development lifecycle, ensuring adherence to FDA 21 CFR 820, ISO 13485, and ISO 14971 standards.
Collaborate with R&D and Regulatory teams to create and maintain design controls, risk management documentation, and verification/validation plans.
Assist in the formation and execution of comprehensive design verification and validation (V&V) testing protocols.
Support the development of thorough product and process risk assessments (FMEAs).
Ensure compliance with Good Documentation Practices (GDP) while participating in internal audits and preparing regulatory submissions.
Work in partnership with suppliers and manufacturing teams to set clear incoming quality standards for components and materials.
Qualifications:
Bachelor's degree in Engineering, Life Sciences, or a related field.
Over 3 years of quality engineering experience in the medical device sector, particularly with pre-market products.
Strong grasp of design control principles, risk management, and V&V testing methodologies.
Experience with ISO 13485, FDA regulations, and the overall product development lifecycle.
Familiarity with biocompatibility, sterilization validation, and usability engineering is a bonus.
This is an outstanding opportunity to be at the forefront of innovation in medical technology before they hit the market. If you have a passion for quality engineering within the early-stage medical device development space, we encourage you to apply today!