Senior Quality Engineer

Ontogen Medtech is a leading provider of design and development services for medical devices. Committed to innovation and excellence, we specialize in delivering cutting-edge solutions that improve outcomes and advance patient care.

Ontogen Medtech is seeking a dynamic and experienced Senior Quality Engineer to join our team. The ideal candidate will possess extensive knowledge and expertise in quality management within the medical device industry, with a focus on design, manufacturing, and supplier quality. Reporting to the Co-Founder, this individual will play a crucial role in ensuring compliance with regulatory standards and quality systems, driving product quality, and initiating continuous improvement, both for Ontogen and for our clients.

Responsibilities

Lead quality assurance activities throughout the product lifecycle, from design quality to manufacturing and post-market.

Assess and mitigate quality risks associated with product design, review DHF documentation, evaluate component risk, and identify critical features.

Develop and implement quality plans and inspection procedures, and test methods.

Evaluate and qualify client suppliers, evaluate manufacturing processes and supplier operations.

Conduct and lead quality audits to ISO 13485 standards, ensuring compliance and identifying areas for improvement.

Collaborate closely with cross-functional teams including internal and client team members throughout the development process.

Investigate non-conformances, root causes, and corrective/preventive actions to drive process improvements and prevent recurrence.

Provide guidance and support to internal stakeholders on quality-related issues, ensuring adherence to regulatory requirements and industry best practices.

Provide support for on-market products, including advising contract manufacturers and making independent decisions regarding the disposition of non-conforming products.

Serve as a subject matter expert on quality standards, regulations, and industry trends, keeping abreast of changes and proactively implementing updates as necessary.

Qualifications

Bachelor's degree in engineering or related field.

Minimum of 8 years of experience in quality engineering role(s) within the medical device industry.

In-depth knowledge of quality management systems, regulatory requirements, and standards, including ISO 13485.

Proven experience in conducting ISO 13485 quality audits and implementing corrective/preventive actions.

Strong understanding of design control processes, manufacturing processes, and supplier management.

Proficiency in risk management methodologies.

Excellent analytical and problem-solving skills, with a keen attention to detail.

Effective communication and interpersonal skills, with the ability to collaborate across teams and with clients and suppliers.

Demonstrated ability to work independently and make sound decisions in a fast-paced environment.

Experience working in a startup or small company environment strongly preferred.

Ontogen offers a comprehensive and competitive benefits package for employees, including quarterly performance bonuses, 401(k) matching, medical/dental/vision insurance, and unlimited PTO. In compliance with federal law, all persons hired will be required to verify identity and eligibility to work in the U.S. and to complete the required verification document upon hire.

Applicants must be currently authorized to work in the United States on a full-time basis. Please note that we are unable to sponsor visas for this position at this time.

*Ontogen Medtech is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.*