Senior Quality Engineer

Magnolia Medical Technologies, Inc. is an early-stage medical device company developing products and solutions that address critical challenges for healthcare systems globally. As we continue to grow, we re adding to the quality team. The Senior Quality Engineer (QE) will be part of a small and nimble group that is supporting the development of revolutionary devices to improve sample collection and integrity for critical in-vitro diagnostic (IVD) tests. The Senior QE will provide quality engineering support to the New Product Development (NPD) team, ensuring NPD activities are conducted in accordance with all internal and external quality requirements. This role is also responsible for working with cross-functional teams in the definition of product requirements and assisting in engineering studies and verification/validation protocols. This is an opportunity to be involved in a wide variety of responsibilities and initiatives, and make a meaningful impact on the development of MMT s growing portfolio of products. This role can be based in either our San Mateo, CA or Seattle, WA offices.

Responsibilities:

• Provides support, mentoring and coaching for the application of technical principles and quality tools and systems.
• Develops technical solutions to complex problems which require the regular use of technical knowledge, experience, ingenuity, and creativity.
• Acts as a core team member for complex design control / process control projects.
• Serves as a CAPA expert as needed.
• Modifies methodologies and procedures, ensuring continuous improvement of desired outcomes.
• Supports quality system audits.
• Provides input to the management review process.
• Ensures the accurate and actionable recording of data for decision making, as well as for documentation of development.
• Contributes to long-range business strategies, choosing disciplines and methods appropriate to the work content and context.
• Seeks continual improvement in reduced cycle times, effectiveness and quality, in support of critical to company objectives.

Required Skills & Experience:

• Ten years of experience in quality engineering, including at least seven years of experience in medical device manufacturing.
• Bachelor s degree in Engineering (Mechanical Engineering preferred), with a Master s degree preferred.
• Minimum 5 years of experience supporting design assurance for medical devices.
• ASQ Certificate(s) preferred.
• Strong Statistical knowledge (e.g., basic collection and analysis of data, statistical process control, acceptance sampling, Design of Experiments, Gage R&R).
• Experienced with Design Controls, Documentation and Organization in an FDA Regulated Environment.
• Familiar with terminology used in the procedures, rules and regulations governing medical device.
• Extensive knowledge of applicable regulatory and Industry standards (21-CFR-820, ISO 13485, MDD, MDR, ISO 14971, ISO 10993, etc.) Ability to speak, write and read English.
• Demonstrated excellence in written and verbal communication.
• Organized, self-motivated, results-driven, and detail-oriented.

Magnolia Medical Technologies, Inc. is changing the medical device landscape in hospitals, clinics, and laboratories around the world. The company builds and markets Steripath, the first product designed and proven to improve sepsis testing accuracy. We are committed to continuing development of innovative products by hiring the best talent and fostering a great working environment with competitive compensation, healthcare benefits, and paid time off.

Magnolia Medical Technologies, Inc. is an equal opportunity employer.

www.magnolia-medical.com

**As a condition of employment with Magnolia Medical Technologies, you are required to provide proof that you are fully vaccinated against COVID-19 or qualify for a reasonable accommodation.