Job description 

Position purpose:  Responsible for Software Quality Assurance (SQA) activities for software in a medical device (SiMD) and Software as a medical Device (SaMD).
 

Key Responsibilities:
1.    Provides Quality Assurance (QA) oversight for software development activities (including post production software changes) for both Agile (ex: sprints) and waterfall software development. 
2.    Provides SQA review of documentation (ex: software development plans, software requirements, software tests, test results, software traceability, risk management documents) to ensure it complies with Alcon procedures, global standards, regulations, and guidances.
3.    Works closely with the Lake Forest Software Quality Lead and stake holders both on-shore and off-shore to coordinate QA oversight of software development activities and associated deliverables. 
4.    Supports audits, regulatory, and other compliance activities by querying, analyzing, and providing requested information and supporting documentation as required for changes in regulatory requirements.
5.    Provides QA review of Computerized System Validation of software tools. 
6.    Provides input into complaint investigations for Software.

Minimum Qualifications:
1.    Bachelor’s Degree in Engineering, or equivalent years of directly related experience
2.    Ability to work independently, proactively identify issues, recommend and implement solutions, and deliver quality results on schedule while managing multiple tasks and internal customers.
3.    Good interpersonal & Communication skills to build positive departmental and inter-departmental relationships in a virtual, remote and asynchronous environment. 
4.    Intermediate MS Office skills (including Outlook, Excel, Word)
5.    Fluent English; excellent verbal and written communication skills
6.    3+ years of relevant experience

Preferred Qualifications:
1.    Understanding of FDA/ISO regulations related to medical device software development (FDA’s General Principles of Software Validation, 21 CFR 820, 21 CFR 11, IEC 62304, ISO 14971, ISO 13485)
2.    Experience with Software development life cycle (Agile/Scrum, waterfall)
3.    Experience with Computerized System Validation of Software Tools (CSA, GAMP)
4.    Experience with software management systems (ex: PLM Windchill, Jira, Polarion, Azure DevOps )
5.    Experience performing audits and internal quality investigations (particularly root cause analysis)
6.    Prior experience on medical device software.