Senior Software Validation Quality Engineer

Primary Function of Position

This position will report into Senior Manager Product Quality Digital & CSA. 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 operate within the framework of regulations (GxP 21CFR11 etc.) applicable Quality Modules and requirements defined in local procedures.
• Provide direct oversight for computer system validation from a quality assurance perspective to ensure quality and compliance requirements are met.
• Provide guidance on CSV validation issues and discrepancies. Support investigation of CSV defects and quality records (deviation CAPAs).
• Review CSV Validation activities including deliverables from regulatory compliance standpoint.
• Provide support to external and internal audits related to computerized system validation activities.
• Advice a cross functional team in an efficient manner including but not limited to excellent communication and time management skills to share responsibilities and expectations and accomplishing goals throughout timelines.
• Help establish and sustain computer system validation global policies and standards that incorporate industry best practices and are health authority compliant.
• Partnering with internal and external teams; sharing information to increase the collective understanding of QA and Compliance programs.
• Solid knowledge of industry standards related to computerized systems and Electronic Records/Electronic Signatures; 21 CFR Part 11 Part 820 Annex 11 GAMP5.
• Ensuring alignment of processes procedures and methods across multiple organizations (internal and external).
• Ensuring systems are fully implemented and integrated with other quality management systems site and global functions.
• Authoring and /or revising SOPs.
• Ability to provide guidance on revising validation documents and protocols.
• Administer applicable electronic systems.
• Assist as needed in audits and inspections.
• Interacts with senior internal personnel and external partners on significant matters often requiring coordination across facility locations.
• Contribute to projects related to CSV improvements.
• Support the Compliance team on computerized system audits to ensure compliant vendor/supplier management program and services.

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 strong 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 Employment Opportunity / Affirmative Action 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.

EEO and AA Policy

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