[Hiring] Quality Manager @Artera

Quality Manager - Remote Opportunity in the USA

About Artera:

Artera is a groundbreaking AI startup revolutionizing medical artificial intelligence tests to personalize cancer therapy. Committed to transforming medical decisions for patients and physicians worldwide, Artera aims to bring individualized treatment plans to the forefront of cancer care.

We are expanding our product portfolio and are on the lookout for a skilled and experienced Quality Manager. This role is pivotal in ensuring our compliance with global regulatory and quality standards, supporting both product development and on-market products.

Job Responsibilities

The Quality Manager will be responsible for:

• Developing and implementing process improvements for post-market surveillance.
• Managing complaint handling, including triaging and documentation within the Quality Management System (QMS) and performing risk analysis.
• Overseeing acceptance activities and document control, ensuring accurate maintenance within the QMS.
• Managing change control processes within product development and for on-market products.
• Ensuring internal teams adhere to established procedures and processes.
• Conducting supplier evaluations and audits.
• Reviewing and maintaining technical documentation and quality procedures.
• Managing and conducting quality management system training.
• Investigating potential device quality issues and deciding on product recalls or market withdrawal.
• Acting as the quality representative during internal and external audits.
• Performing risk assessments, developing quality assurance plans, V&V records, and testing strategies.
• Collaborating with cross-functional teams (product, AI, clinical development, engineering, operations, and legal) to ensure alignment on quality requirements.
• Providing regular updates and business reviews to the Leadership Team.

Key Qualifications

Education & Experience Requirements:

• Bachelor's degree in Engineering, Life Sciences, or a related field.
• Minimum of 5 years of experience in quality management within the medical device industry.
• Thorough knowledge of regulatory requirements and quality standards (e.g., ISO 13485, FDA 21 CFR Part 820).
• Exceptional analytical and problem-solving skills.
• Excellent written and verbal communication skills, with the ability to convey quality concepts to non-technical stakeholders.
• Experience in leading and managing audits and inspections, with interface experience with global regulatory agencies.
• Proficiency in performing risk assessments, creating quality assurance plans, and developing V&V records and testing strategies.
• Experience in handling complaints and developing process improvements for post-market surveillance.
• Proficient in change management within product development and on-market products.
• Familiarity with US and global product quality standards and regulations.
• Compliance with ethical, legal, and regulatory requirements specific to the medical device industry.
• Effective leadership, management, and teamwork skills.
• Ability to work independently with minimal oversight and direction.
• Ability to manage and prioritize multiple tasks and projects effectively.
• Flexibility and adaptability to thrive in a dynamic startup environment.
• A strong vision and desire to build and grow an organization with a clear mission.
• Expected Travel: <5% domestic travel

Preferred Experience:

• Certification in Quality Management (e.g., ASQ Certified Quality Manager).
• Familiarity with CLIA, CAP, and NYS CLEP requirements.
• Experience participating in design control processes from product conception to monitoring.
• Experience with Software as a Medical Device (SaMD).

Equal Employment Opportunity

At Artera, we value diversity and inclusiveness. We are committed to developing innovative solutions for patients and physicians by bringing together a diverse workforce. As an equal opportunity employer, we do not discriminate based on race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, protected veteran status, or any other legally protected characteristic.

Join us in our mission to revolutionize cancer care with personalized medical decisions. Apply now to be a