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QA/RA Consultant
Venturefizz Product Management Community
- Boston, Massachusetts, United States
- Boston, Massachusetts, United States
À propos
Our ideal candidate will have demonstrated success in quality systems management with 5‑8 years of experience in the medical device industry. Someone who is strategic yet hands‑on, passionate about regulatory excellence, and eager to leverage cutting‑edge AI technology will thrive in this position. In this role, you'll have the opportunity to directly impact our mission to improve 100 million patient lives by 2030 by ensuring the highest quality standards for life‑saving medical devices.
This position will be based in our Boston, Massachusetts office with a hybrid schedule (Monday, Tuesday, Thursday, Friday in office, Wednesday WFH option). Applicants must be authorized to work for any employer in the U.S.
Responsibilities:
Lead Quality Management System (QMS) setup and deployment for medical device clients.
Own and manage QMS templates and regulatory compliance frameworks.
Provide expert consulting on ISO 13485, MDSAP, GxP, and other quality systems standards.
Scale operations to support high‑growth clients.
Develop repeatable QMS deployment processes leveraging AI platform capabilities and automatic compliance.
Shape the future of regulatory affairs through innovative product development.
Work independently on complex quality assurance projects requiring minimal oversight.
Ensure customer success across the entire customer engagement lifecycle.
Required Skills:
4‑8 years of experience in quality systems management, management representative or senior specialist role.
Familiar with eQMS implementation, validation and implementation.
Deep expertise in Quality Management System setup, sub‑systems, and implementation.
Strong knowledge of ISO 13485 and Global QMS requirements.
Expertise in AI, Digital, and Cyber Compliance.
Deep understanding of medical device cybersecurity.
Experience as quality management representative in regulated environments.
Experience with regulatory and Notified Body submission requirements.
Background in medical device industry quality systems.
Ability to work independently and own complex regulatory projects.
Proven track record in consulting or client‑facing roles.
Preferred Skills:
Experience at large medical device companies (Stryker, Medtronic, Boston Scientific).
Background with consulting firms specializing in QMS setup.
Startup experience (Series A/B) with QMS implementation.
Specializations in cybersecurity, usability, or computer software validation.
Experience scaling quality operations in high‑growth environments.
Knowledge of AI applications in regulatory affairs.
Submission experience.
Experience working in an early stage, product‑based startup.
What We Offer:
Competitive compensation
Generous stock options possible
Work in an exciting field with a positive impact on the world
Opportunity to learn and grow as part of a global team
Generous PTO for full‑time
Ketryx is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to age, ancestry, color, family or medical care leave, gender identity or expression, genetic information, marital status, medical condition, national origin, physical or mental disability, political affiliation, protected veteran status, race, religion, sex (including pregnancy), sexual orientation, or any other characteristic protected by applicable laws, regulations and ordinances.
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Compétences linguistiques
- English
Avis aux utilisateurs
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