Senior Engineer, Quality

Role Overview

• Develop and implement quality assurance processes for medical devices in compliance with industry standards and regulations, including: IEC/ISO 62304: Medical Device Software Lifecycle, 21 CFR 820.30: Design Controls, ISO 14971: Medical Device Risk Management, IEC 60601: Medical Device Electrical Safety, ISO 10993: Biological Evaluation of Medical Devices, IEC 62366-1: Application of Usability Engineering to Medical Devices
• Assure thorough testing and validation of software and hardware systems to ensure they meet specified requirements and are free from defects.
• Collaborate with cross-functional teams to define quality metrics, standards, and procedures throughout the software and product development life cycle.
• Assist with cross-functional risk assessments and contribute to the creation of risk management plans related to software and product quality.
• Review and assure that verification test plans, test cases, and validation protocols are complete and provide meaningful results to confirm design outputs meet design inputs.
• Stay updated on industry trends, regulatory changes, and best practices in medical device software and product quality.
• Participate in audits and inspections to ensure compliance with relevant quality standards and regulations.
• Investigate and analyze reported product defects, providing detailed and accurate reports to support corrective and preventive actions (CAPAs).
• Facilitate communication between development teams and regulatory affairs to address quality-related issues.
• Contribute to continuous improvement initiatives by leading complaint investigations, CAPAs, and other corrective actions.
• Review design specifications for clarity, testability, and regulatory compliance.
• Participate in design reviews for new products and establish quality plans.
• Facilitate pre
• and post-market risk management activities.
• Maintain accurate records to assure regulatory compliance throughout the product lifecycle.

Requirements

• B.S. degree in Engineering (materials, biomedical, or mechanical)
• Minimum 8 years of specialized experience in a medical disposables/device products field or advanced technical degree.
• Experience in compliant practices of design control and medical device risk management.
• Excellent verbal and written communication skills.
• Strong leadership and project management skills.
• Strong analytical capability and attention to detail.
• Ability to operate independently and exercise good judgment.
• Able to use electronic systems including IT equipment to carry out duties

Benefits

• 401(k) plan with company contributions
• Paid vacation
• Holiday and personal days
• Employee assistance program
• Health benefits including medical, prescription drug, dental, and vision coverage