Software Quality Assurance Engineer III

POSITION SUMMARY:
The SQA Engineer III supports the quality system & processes of the Natera CLIA laboratories and activities associated with software & assays. This position represents compliance requirements related to software implementation & product development projects, leads audits (internal, supplier, and external), leads activities associated with software validation following Software Development Life Cycle (SDLC) process for software that is part of a medical device.

With limited supervision, works directly with software engineering to ensure compliance of procedures to FDA Part 820, IEC62304, ISO 14971, CAP/CLIA/NYS requirements; guide planning of software verification and validation activities; perform risk and / or impact assessments for software systems; support preparation, execution, and resolution of internal and external audits. Work with regulatory affairs to develop content of regulatory submissions. Work with software engineering compliance, this position will provide value-added guidance throughout the software lifecycle. Support CAPA, Deviation, and Nonconformance investigation and reporting. Other duties as assigned. 

PRIMARY RESPONSIBILITIES:
1. Lead validation & verification (V&V) & risk management (sFMEA) activities (perform risk and/or impact assessments for Lab, Product, and Quality Management software systems). Participate in software design control and design reviews. 
2. Review software change requests and maintenance updates following change control and maintenance release process. Review associated test plans, protocols, and reports; represent software QA on development and release projects. 
3. Support preparation and execution of internal and supplier audits as well as hosting external audits related to software.  
4. Participate and/or lead computer system validation / Spreadsheet validation projects; draft val plans, IQ/OQ/PQ software protocols, and reports; provide guidance on drafting requirements, specifications and procedures; perform risk based validation testing, and ensure validation state of software systems are maintained. 
5. Participate in development of regulatory content for submissions to regulatory authorities. 
6. Participate and/or lead cross-functional teams to investigate and resolve software nonconformities, deviations, CAPAs, and complaints.  
7. Partners with leadership to implement strategies for software compliance. Responsibilities are assigned based on demonstrate competency. 

QUALIFICATIONS:

8 yrs experience in Biotech industry preferred or a relevant comination of skills, education and experience

Bachelor's degree in Life Sciences, Engineering, Software or equivalent

ASQ or SQA certification preferred

KNOWLEDGE, SKILLS & ABILITIES:
1. Preferred experience/knowledge with software code review; leading large, complex software validation projects, including custom software application validation. 
2. Knowledge of regulatory requirements for non-product and product software (21 CFR Part 11, part 820, Annex 11, 13485, IEC 62304, 14971) to be able to respond to SQA/CSV related regulatory/compliance queries.
3. Extensive knowledge of QA methodologies, test planning, system dependencies, and software SDLC phases.
4. Good at task execution, working in agile environment, ability to work independently as well as in a team, with good communication skills.