Sr Software Quality Engineer

Primary Function of Position

This position will report into Senior Manager Software Quality Engineering. The primary responsibility of this person is to represent PQ as a selfdirected quality oversight on the GxP Computerized Systems Validation efforts globally across Intuitive sites around the world.

Essential Job Duties

• Maintains responsibilities for ensuring GxP computerized systems including SaMD/SiMD AIenabled platforms and IT digital systems operate within the framework of regulations (GxP 21 CFR Part 11/820 EU MDR) applicable Quality Modules IEC 62304 ISO 14971 and requirements defined in local/global procedures.
• Provide direct oversight for software lifecycle activities and computer system validation (CSV) from a quality assurance perspective to ensure compliance with SDLC risk management AI lifecycle controls cybersecurity and documentation rigor.
• Provide guidance on CSV software assurance and IEC 62304 validation issues and discrepancies. Support investigations of softwarerelated defects deviations and CAPAs including root cause analysis aligned with ISO and FDA expectations.
• Review CSV and software validation activities including deliverables (traceability matrices test protocols risk analyses) from a regulatory compliance and quality standpoint ensuring endtoend lifecycle integrity.
• Provide support to internal and external audits including health authority inspections related to SaMD/SiMD AIenabled systems and computerized system validation activities ensuring readiness and documentation traceability.
• Advise crossfunctional teamsR&D IT Regulatory and QAin an efficient and collaborative manner demonstrating proven communication and time management skills to achieve quality milestones across complex project timelines.
• Help establish and sustain global computer system validation and software quality policies and standards incorporating industry best practices GAMP 5 guidance and health authority compliance requirements for both traditional and AIbased systems.
• Partner with internal software development teams AI/ML engineers cybersecurity and external suppliers/vendors to ensure alignment of software quality expectations algorithm transparency and lifecycle compliance in AIpowered digital health systems.
• Solid knowledge of industry standards related to regulated software and Electronic Records/Electronic Signatures including 21 CFR Part 11 Part 820 Annex 11 GAMP 5 IEC 62304 ISO 14971 and emerging AI regulatory frameworks (e.g. EU AI Act FDA AI/ML guidance).
• Ensure alignment of validation and quality assurance processes procedures and methods across multiple product lines business units and global functions including IT and engineering.
• Ensure SaMD/SiMD systems and AIenabled tools are implemented in accordance with regulatory requirements and fully integrated with enterprise quality systems (e.g. QMS LMS eDMS eQMS).
• Author and/or revise standard operating procedures (SOPs) work instructions and templates related to software quality engineering AI function deployment SDLC and CSV activities.
• Ability to provide expert guidance on validation document and protocol revisions including test scripts design documentation AI model traceability training data documentation and verification strategies.
• Administer and support applicable electronic systems used for quality and compliance purposes (e.g. ALM Jira AI governance platforms eQMS systems like Veeva or TrackWise).
• Assist as needed in audits and inspections including preparing documentation supporting interviews and addressing audit findings for SaMD/SiMD AIenabled systems and digital platforms.
• Interact with senior internal personnel and external partners on critical software quality and compliance matters including AI functionality validation requiring coordination across multiple global facility locations and teams.
• Contribute to projects focused on CSV and SDLC process improvements digital transformation and increasing validation efficiency through automation AIdriven quality tools and Agile/DevOps alignment.
• Support the Compliance team on computerized system and AI system audits ensuring vendor qualification algorithm lifecycle oversight and supplier management programs are effectively maintained for software and AI/ML service providers.

Qualifications :

Required Skills and Experience

• 68 years experience in the Medical Device/FDAregulated industry with 35 years in Software Quality Engineering Quality Assurance or Software Compliance roles.
• Bachelors or higher degree in Computer Science Software Engineering Informatics Biomedical Engineering or related fields (advanced degrees preferred).
• Comprehensive knowledge of computer system validation (CSV) and regulatory requirements including 21 CFR Part 11 GMP and GAMP guidelines.
• Expertise in medical device software standards such as IEC 62304 ISO 14971 IEC 60601 and FDA Design Controls.
• Proven experience working on embedded software (SiMD) and Software as a Medical Device (SaMD) including development verification and validation.
• Strong proficiency in design control processes including generating reviewing and approving documentation throughout the SDLC such as DHF deliverables SRS SAD SDS V&V traceability risk management/FMEA and cybersecurity.
• Maintain knowledge of the evolving regulatory landscape for Digital Health Artificial Intelligence and Machine Learning technologies incorporating best practices into SDLC processes and QMS.
• Experience with risk management including conducting risk assessments software risk analysis and FMEA in medical device software development.
• Knowledge of cybersecurity assessments and risk mitigation as part of software quality management.
• Familiarity with Agile/Scrum methodologies and SDLC tools like JIRA DOORS and Jama for requirements management and issue tracking.
• Handson experience validating ERP systems (e.g. SAP) SaaS platforms and COTS applications in compliance with regulatory standards.
• Proven ability to support compliance to various QMS procedures and activities including risk management internal and external audits change control and training.
• Proven ability to collaborate with crossfunctional teams (e.g. R&D software engineering IT) and represent the Quality Engineering function in technical and management reviews.
• Strong experience supporting internal and external audits to meet compliance with software quality and regulatory standards.
• Excellent communication negotiation and interpersonal skills with advanced problemsolving and decisionmaking abilities.
• Resultsdriven with exceptional attention to detail organizational skills and a commitment to quality and customer focus.

Additional Information :

Due to the nature of our business and the role please note that Intuitive and/or your customer(s) may require that you show current proof of vaccination against certain diseases including COVID19. Details can vary by role.

Intuitive is an Equal Employment Opportunity Employer. We provide equal employment opportunities to all qualified applicants and employees and prohibit discrimination and harassment of any type without regard to race sex pregnancy sexual orientation gender identity national origin color age religion protected veteran or disability status genetic information or any other status protected under federal state or local applicable laws.

We will consider for employment qualified applicants with arrest and conviction records in accordance with fair chance laws.

We provide marketcompetitive compensation packages inclusive of base pay incentives benefits and equity. It would not be typical for someone to be hired at the top end of range for the role as actual pay will be determined based on several factors including experience skills and qualifications. The target salary ranges are listed.

Due to the nature of our business and the role please note that Intuitive and/or your customer(s) may require that you show current proof of vaccination against certain diseases including COVID19.  Details can vary by role.

Intuitive is an Equal Opportunity Employer. We provide equal employment opportunities to all qualified applicants and employees and prohibit discrimination and harassment of any type without regard to race sex pregnancy sexual orientation gender identity national origin color age religion protected veteran or disability status genetic information or any other status protected under federal state or local applicable laws.

Mandatory Notices

We will consider for employment qualified applicants with arrest and conviction records in accordance with fair chance laws.

Preference will be given to qualified candidates who do not reside or plan to reside in Alabama Arkansas Delaware Florida Indiana Iowa Louisiana Maryland Mississippi Missouri Oklahoma Pennsylvania South Carolina or Tennessee.

We provide marketcompetitive compensation packages inclusive of base pay incentives benefits and equity. It would not be typical for someone to be hired at the top end of range for the role as actual pay will be determined based on several factors including experience skills and qualifications. The target salary ranges are listed.

Remote Work :

No

Employment Type :

Fulltime