Sr. Software Quality Engineer

About the Role

Key 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 guides 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).
• Ensures that all activities relating to risk management are carried out in accordance with the risk management plan.
• Acts as a cybersecurity and data privacy Subject Matter Expert for global PD products, assessing residual risks and planning cybersecurity measures.
• Evaluates events within the scope of complaints/incidents and vulnerability management, coordinating product-related cybersecurity activities.
• Defines 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 provides solutions to potential risks.
• Develops and manages internal and external regulatory audits/inspections by presenting and defending software projects and documentation.
• Follows all policies, guidelines, and SOPs as required.
• Networks with senior internal and external personnel in own area of expertise.
• Assists with various duties and projects as assigned by a supervisor.

Requirements

• Bachelor's Degree required in Computer Science, Software Engineering, or related field; Advanced Degree desirable.
• Solid experience in software engineering, information technology, or software quality assurance in a regulated environment.
• Understanding of Agile methodology desired but not required.
• Thorough understanding of FDA Quality System regulations related to software development and validation or strong motivation to learn.
• Extensive experience with one or more of the following: SAP, PTC, WindChill, Pilgrim.
• 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 Have

• Understanding of Agile methodology.

Qualifications

• Bachelor's Degree in Computer Science, Software Engineering, or related field.