Fresenius Medical Care · 1 day ago
Sr. Software Quality Engineer
Lawrence, MA
Full-time
Onsite
Senior Level
$120K/yr - $140K/yrFresenius Medical Care is seeking a Senior Software Quality Engineer to act as a Quality Business Partner for software engineering teams. The role involves ensuring product quality, compliance with regulations, and supporting risk management activities.
BiotechnologyHealth CareMedical Device
Responsibilities
Works as part of software development team on new product development or on design changes to ensure product quality and minimize risk to users and patients as well as regulatory and corporate SOP compliance
Reviews and approves design control deliverables along the product development process as well as design changes
Partners with and/or guide software project teams to ensure that software systems are compliant with procedures and Regulations such as 21CFR 820.30, IEC62304:2016 amd.1, IEC81001-5-1, as well as FDA and MDCG guidance
Responsible for the planning and implementation of risk management, the creation and updating of the risk analysis while complying with the relevant standards
Responsible for the specification of risk reduction measures (requirement management)
Ensuring that all activities relating to risk management are carried out in accordance with the risk management plan
This position is also a cybersecurity and data privacy Subject Matter Expert for global PD products
Assessing the acceptability of cybersecurity residual risks
Involvement in the planning of the product roadmap for the implementation of appropriate cybersecurity measures
Evaluation of events (post-market surveillance) within the scope of complaints/incidents and vulnerability management coordination of product related cybersecurity activities
Involvement in the definition of policies, SOPs and guidelines for cybersecurity and data privacy
Compiles, maintains, and evolves approved project deliverables
Communicates project and compliance issues to Quality Systems management and provide solutions to potential risks
Develops and project manages internal and external regulatory audits/inspections by presenting and defending software projects and documentation during audits and inspections as the Subject Matter Expert
Follows all policies, guidelines, and SOPs as required
Works on problems of diverse scope where analysis of data requires evaluation of identifiable factors. Demonstrates good judgment in selecting methods and techniques for obtaining solutions
Networks with senior internal and external personnel in own area of expertise
May escalate issues to supervisor/manager for resolution, as deemed necessary
Reviews and complies with the Code of Business Conduct and all applicable company policies and procedures, local, state, and federal laws and regulations
Assists with various duties and projects as assigned by a direct supervisor
Additional responsibilities may include focus on one or more departments or locations. See applicable addendum for department or location specific functions
Qualification
Required
Bachelor's Degree required in Computer Science, Software Engineering, or related field
Solid experience in software engineering, information technology, or software quality assurance in a regulated environment
Thorough understanding of FDA Quality System regulations in relation to software development and validation or strong motivation to learn
Excellent verbal and written communication skills
Excellent team work and interpersonal skills
Very strong analytical and problem solving skills
Excellent attention to detail, resourceful, self-reliant, self-motivated and confident
Preferred
Understanding of Agile methodology desired but not required
Advanced Degree desirable
Extensive experience with one or more of the following highly desirable: SAP, PTC, WindChill, Pilgrim
Benefits
Medical, dental, and vision insurance
401(k) with company match
Paid time off
Parental leave
Company
Fresenius Medical Care
Fresenius Medical Care is a healthcare company that provides dialysis treatment for those with chronic kidney diseases.
Founded in 1912
10001+ employees
H1B Sponsorship
Fresenius Medical Care has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (2)
2024 (5)
2023 (14)
2022 (18)
2021 (10)
2020 (20)
Funding
Current Stage
Public CompanyTotal Funding
$758.43M2025-11-17Post Ipo Debt· $579.5M
2025-07-21Post Ipo Equity· $4.86M
2020-02-25Post Ipo Equity· $6.07M
Leadership Team
Helen Giza
Chief Executive Officer and Chair of the Management Board
Olaf Schermeier
Member of the Management Board - CEO Global R&D
Recent News
2025-11-19
2025-11-11
Company data provided by crunchbase