What are the responsibilities and job description for the Sr. Software Quality Engineer position at Fresenius Medical Care Holdings, Inc.?
This is a Full-Time, Hybrid position located at our corporate office in Lawrence, MA. PURPOSE AND SCOPE 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 PRINCIPAL DUTIES AND 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.
See applicable addendum for department or location specific functions. PHYSICAL DEMANDS AND WORKING CONDITIONS
Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
