Engineering Specialist, Quality

Fresenius Kabi USA•North Andover, MA

1d•$160,000 - $170,000•Hybrid

About The Position

The Engineering Specialist, Quality supports: the product development process, requirement planning and reviews, verification planning, review of test case methods, & defect management and related risk assessments. Additionally, this position will support and improve active and disposable medical devices with an emphasis on design control and risk management processes supporting the North Andover Design Center Projects.

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

Responsibilities

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
Provide quality oversight for software deliverables, ensuring compliance with software lifecycle requirements including software risk management, cybersecurity considerations, traceability, and release readiness per IEC/ISO 62304.
Strengthen and maintain the QMS structure for design and software quality by defining workflows, templates, and governance for document control, change control, design reviews, DHF/DMR readiness, and inspection preparedness.
All employees are responsible for ensuring the compliance to company documents, programs and activities related to the Health, Safety, Environment, Energy, and Quality Management Systems, as per your roles and responsibilities