QA Lead Software and Regulatory - Kohler Ventures

About the position Kohler Ventures is seeking a QA Lead who is passionate about designing and building products for health and wellness. This role is crucial in ensuring that software verification and validation are carried out in compliance with the policies and procedures in an FDA-regulated environment. The ideal candidate will have a successful track record in regulatory and software lifecycle management methodologies for health and wellness products, as well as experience mentoring technical professionals on these requirements. The QA Lead will actively contribute to all aspects of Software Quality Assurance activities, supporting the development of an electronic Quality Management System compliant with 21 CFR Part 820, ISO 13485, and other relevant regulations and standards. The QA Lead will interpret applicable regulations and standards, engaging with internal stakeholders to devise compliant quality procedures and processes that consider product risk. Responsibilities include ensuring that products meet applicable standards and guidance, authoring or reviewing documentation associated with qualification planning, user requirements, hazard analysis, functional and design specifications, and test protocols. The candidate will also review and approve changes to existing systems from a Software QA perspective, ensuring compliance with internal procedures and external standards. In addition, the QA Lead will ensure that best software QA practices are employed across departments, support regulatory agency inspections, and lead change management activities for software and firmware. The role requires a strong understanding of wellness product regulations and the software development life cycle (SDLC), as well as experience in software testing and verification/validation. The candidate should be available to work outside of standard business hours as needed and be willing to travel up to 10% of the time, both domestically and internationally.

Responsibilities

• Actively contribute to all aspects of Software Quality Assurance activities in an FDA-Regulated environment.

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• Support development of an electronic Quality Management System compliant with 21 CFR Part 820, ISO 13485, and other relevant regulations and standards.

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• Interpret applicable regulations and standards and engage with internal stakeholders to devise compliant quality procedures and processes that consider product risk.

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• Ensure product meets standards and guidance such as FDA Design Controls CFR 820.30, IEC 62304, IEC 14971, ISO 13485, and 2017/745 (EU MDR).

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• Author or review and approve documentation associated with qualification planning, intended use, user requirements, hazard analysis, functional and design specifications, design reviews, test protocols, requirements trace matrix, and qualification reports.

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• Review and approve changes to existing systems from a Software QA perspective, ensuring compliance with internal procedures and external standards.

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• Review test results for compliance with Good Documentation Practices and ensure that all test discrepancies to acceptance criteria are adequately controlled, documented, and addressed.

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• Ensure that best software QA practices are employed by all departments for software/firmware-based systems.

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• Support regulatory agency inspections and debrief management on audit outcomes, sharing trends and findings, and recommending corrective and preventive action items.

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• Lead change management activities for software/firmware.

Requirements

• 5+ years of demonstrated success in fast-paced Software QA roles for hardware/software products in the health space.

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• 5+ years with Quality Management Solutions (QMS) implementation and oversight.

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• Bachelor's Degree in Engineering, Computer Science or other Life Sciences.

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• 5+ years of experience with wellness product regulations for hardware and the software development life cycle (SDLC).

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• Experience in software testing and verification/validation.

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• Experience in developing and maintaining design history files and technical files.

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• Experience with software configuration and issue tracking tools such as GIT, Jira, Subversion, ClearQuest, Doors, Bugzilla.

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• Experience in technical writing for software development processes and deliverables.

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• Experience in developing SOPs, work instructions, and report templates and training personnel in accordance with applicable regulations.

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• Working knowledge of the regulations and standards set forth under 21 CFR Part 820, ISO 13485, ISO 14971, and IEC 62304.

Nice-to-haves

• ASQ certifications are a plus.

Benefits

• Health insurance

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• Dental insurance

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• 401(k)

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• Vision insurance

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• Performance bonus

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• Special project incentive

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