Hybrid Engineering Specialist, Quality

at Fresenius Kabi USA

• Job title: Engineering Specialist, Quality
• Job type: Full Time
• Experience level: Senior, Lead
• Salary: $160,000 - $170,000 per year
• Degree requirement: Bachelor's Degree
• Location requirements: Hybrid, North Andover, United States

About the role

• Engineering Specialist handling quality assurance processes and risk management for medical devices. Supporting product development lifecycle in compliance with industry standards at Fresenius Kabi.

Responsibilities

• Develop and implement quality assurance processes for medical devices in compliance with industry standards and regulations
• 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
• Provide quality oversight for software deliverables, ensuring compliance with software lifecycle requirements
• Strengthen and maintain the QMS structure for design and software quality by defining workflows, templates, and governance for document control

Requirements

• Bachelor’s degree in Engineering or related field or Associates degree with 15+ years of relevant experience
• Greater than 10 years of related experience in the medical device industry or equivalent combination of education and experience
• Demonstrated knowledge of IEC/ISO 62304 Medical Device Software Lifecycle and 21 CFR 820.30 Design Controls
• Experience with FDA regulations, specifically medical device software
• Experience in compliance to GMPs
• Excellent leadership and communication skills
• Ability to operate independently exercising good judgement
• Ability to mentor junior staff
• 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 to include medical, prescription drug, dental and vision coverage