Sr. Software Quality Engineer

Fresenius Medical Care•Lawrence, MA

22h•Onsite

About The Position

Act as a Quality Business Partner for Software as a Medical Device and Non-medical software device engineering teams to ensure compliant products, engineering teams are supported with a value-added mindset, and Post Market Surveillance activities are performed, and actions derived.

Requirements

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.

Nice To Haves

Advanced Degree desirable.
Understanding of Agile methodology desired but not required.
Extensive experience with one or more of the following highly desirable: SAP, PTC, WindChill, Pilgrim.

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.