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Artera

USA

Posted on: 19 June 2024

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Quality Manager

About Us: Artera is an AI startup that develops medical artificial intelligence tests to personalize therapy for cancer patients. Artera is on a mission to personalize medical decisions for patients and physicians on a global scale.

As we continue to expand our product portfolio, we are seeking a dynamic and experienced Quality Manager to ensure our compliance with global regulatory and quality requirements. The Quality Manager will be responsible for planning, directing, and coordinating quality activities to support Artera’s product development and on-market products.

The Quality Manager will play a crucial role in maintaining compliance with relevant authorities. This role requires a detail-oriented thinker with a firm understanding of quality requirements, excellent leadership skills, and the ability to collaborate cross-functionally to implement successful quality objectives. This position will make a significant impact on the culture, communication, and dynamics of a growing commercial organization.

Essential Responsibilities:

Develop and implement process improvements for post-market surveillance.

Manage on-market complaint handling, including triaging and documentation within the Quality Management System (QMS) and performing risk analysis.

Oversee acceptance activities and document control, ensuring records are accurately maintained in the QMS.

Manage change control processes within product development and for on-market products.

Ensure internal teams adhere to established procedures and processes.

Conduct supplier evaluations and audits.

Review and maintain technical documentation and quality procedures.

Manage and conduct quality management system training.

Investigate potential device quality issues and act as a key decision-maker in determining if a product needs to be recalled or pulled from the market.

Act as the quality representative during internal and external audits.

Perform risk assessments and develop quality assurance plans, V&V records, and testing strategies.

Collaborate closely with cross-functional teams, including product, AI, clinical development, engineering, operations, and legal, to ensure alignment on quality requirements and product development processes.

Provide regular updates / business reviews to the Leadership Team.

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.

In-depth knowledge of regulatory requirements and quality standards (e.g., ISO 13485, FDA 21 CFR Part 820).

Strong 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, as well as experience interfacing with global regulatory agencies.

Proficient in performing risk assessments, creating quality assurance plans, and developing V&V records and testing strategies.

Experienced in handling complaints and developing process improvements for post-market surveillance.

Responsible for change management within product development and on-market products.

Familiarity with US and non-US based product quality standards and regulations.

Understands and complies with ethical, legal, and regulatory requirements applicable to the medical device industry.

Effective leadership, management, and teamwork skills.

Strong written and verbal communication skills; proactive cross-functional communicator.

Ability to work independently with minimal oversight and direction.

Ability to effectively manage and prioritize multiple tasks and projects.

Flexibility and adaptability to work in a dynamic and rapidly changing start-up environment.

Strong desire and vision to build a new organization with a clear vision.

Expected Travel: <5% domestic

Desired Experience:

Certification in Quality Management (e.g., ASQ Certified Quality Manager).

Experience 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 Employee Opportunity: At Artera, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients and physicians. As an equal opportunity employer, we do not discriminate on the basis of 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.