IVD product software validation specialist

POSITION SUMMARY:

The position 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.

 

The pay range is listed and actual compensation packages are based on a wide array of factors unique to each candidate, including but not limited to skill set, years & depth of experience, certifications and specific office location. This may differ in other locations due to cost of labor considerations.Remote USA$111,300—$139,150 USD

OUR OPPORTUNITY

Natera™ is a global leader in cell-free DNA (cfDNA) testing, dedicated to oncology, women’s health, and organ health. Our aim is to make personalized genetic testing and diagnostics part of the standard of care to protect health and enable earlier and more targeted interventions that lead to longer, healthier lives.

The Natera team consists of highly dedicated statisticians, geneticists, doctors, laboratory scientists, business professionals, software engineers and many other professionals from world-class institutions, who care deeply for our work and each other. When you join Natera, you’ll work hard and grow quickly. Working alongside the elite of the industry, you’ll be stretched and challenged, and take pride in being part of a company that is changing the landscape of genetic disease management.

WHAT WE OFFER

Competitive Benefits - Employee benefits include comprehensive medical, dental, vision, life and disability plans for eligible employees and their dependents. Additionally, Natera employees and their immediate families receive free testing in addition to fertility care benefits. Other benefits include pregnancy and baby bonding leave, 401k benefits, commuter benefits and much more. We also offer a generous employee referral program!

For more information, visit www.natera.com.

Natera is proud to be an Equal Opportunity Employer. We are committed to ensuring a diverse and inclusive workplace environment, and welcome people of different backgrounds, experiences, abilities and perspectives. Inclusive collaboration benefits our employees, our community and our patients, and is critical to our mission of changing the management of disease worldwide.

All qualified applicants are encouraged to apply, and will be considered without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, age, veteran status, disability or any other legally protected status. We also consider qualified applicants regardless of criminal histories, consistent with applicable laws.

If you are based in California, we encourage you to read this important information for California residents. 

Link: https://www.natera.com/notice-of-data-collection-california-residents/

Please be advised that Natera will reach out to candidates with a @natera.com email domain ONLY. Email communications from all other domain names are not from Natera or its employees and are fraudulent. Natera does not request interviews via text messages and does not ask for personal information until a candidate has engaged with the company and has spoken to a recruiter and the hiring team. Natera takes cyber crimes seriously, and will collaborate with law enforcement authorities to prosecute any related cyber crimes.

For more information:
- BBB announcement on job scams 
- FBI Cyber Crime resource page 

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