About the role

The Sr. Supplier Quality Engineer will be part of a small and nimble Quality and Regulatory group that is creating revolutionary devices to improve sample collection and integrity for critical in-vitro diagnostic (IVD) tests. You will provide quality leadership and guidance responsible for consistent implementation, improvement and compliance to the Magnolia’s Quality System and global regulatory requirements including, but not limited to: FDA (§21 CFR 820, ISO13485, Canadian Medical Device Regulatory (CMDR), and EU MDR 745). In collaboration with multi-departmental stakeholders from Product Development, Operations, Supply Chain, Manufacturing, and Quality Assurance, this role develops procedures, workflows, and manages the supplier quality program.

A strong sense of ownership, great communication skills, and excellent time management skills will ensure success at Magnolia. The right individual to join our team is a self-starter with a dive in and get-it-done approach to trying new ideas, prototyping, and solving problems. The SQE will be motivated to create products that work elegantly to solve real clinical problems, help patients, and make the job better and easier for clinicians.

About us

Magnolia Medical is an emerging growth commercial-stage medical device company developing products and solutions that address critical challenges for healthcare systems globally. Magnolia Medical Technologies is a privately held organization, delivering revolutionary solutions to challenges that have long plagued our healthcare system. We design and build products that significantly improve patient outcomes. We have launched the innovative and broadly patented Steripath® blood collection system, the only device on the market proven to significantly reduce false positive blood cultures - the standard-of-care for diagnosing sepsis. We have achieved outstanding clinical results and proudly count some of the most respected healthcare systems in the country as early customers. We are offering qualified candidates an opportunity to get in early and help build a company dedicated to improving the health and well-being of millions of people around the world.

Responsibilities:

• Manage all aspects of the Supplier Quality program. Collaborate with Suppliers to assure ongoing QMS compliance
• Support cross-functional engineering teams with activities such as design change analysis and design requirements, and ensure compliance with applicable processes and regulations
• Participate in risk management activities in accordance with ISO 14971 (Risk Management Plan, Hazard Analysis, FMEAs, RM Report)
• Develop policies and procedures to continuously improve the Quality Management System
• Participate in internal and external audits and regulatory inspections
• Review quality records and documentation

Personal Qualities:

• Strong analytical and problem-solving skills with a highly-oriented process approach (RCA, DMAIC, Six Sigma)
• Strong interpersonal skills, ability to work well with others in both one-on-one interactions as well as team activities
• Excellent oral and written communication skills
• Organized, hands-on, self-motivated, and detail-oriented

Required Skills & Experience:

• Five (5) to eight (8) years of experience in a medical device manufacturing environment, supplier management, or other regulated industries
• Bachelor’s degree in Engineering or related science field
• Quality Management System and Document Management Experience
• Expertise with 21 CFR 820 and ISO 13485
• Experience with ISO 14971 and EU MDR and CE regulatory requirements
• Strong experience with leading audits
• Experience with process/equipment validations and risk management
• Strong in Microsoft Office and statistical analysis software
• Strong technical writing skills
• Travel to Supplier sites as needed

Magnolia Medical Technologies is committed to the continued development and successful marketing of innovative products that will improve the way healthcare is practiced around the world. We offer competitive compensation based on experience level, along with benefits, career growth opportunities, and incentives (including equity) to the most qualified candidates in the marketplace. Magnolia Medical Technologies, Inc. is an equal opportunity employer.

About Magnolia Medical Technologies:

Magnolia Medical Technologies develops, manufactures, and markets innovative blood and bodily fluid collection devices to facilitate significant improvements in the accuracy, consistency, and predictability of critical laboratory tests.

Dr. Richard Patton, the company’s co-founder and Medical Director invented and patented the Initial Specimen Diversion Technique (ISDT™) and Initial Specimen Diversion Device (ISDD®) for blood culture collection and contamination prevention and authored the seminal peer-reviewed publication on this technique published in the Journal of Clinical Microbiology in 2010.

The company’s flagship product, Steripath® Initial Specimen Diversion Device® for blood culture collection and contamination prevention, has been clinically proven in several clinical studies and peer-reviewed publications to virtually eliminate the preventable error of blood culture contamination and false positive results for the diagnosis of Sepsis.

Magnolia is establishing the new standard for blood culture integrity and sepsis testing accuracy with a mission to change national blood culture collection guidelines and contamination benchmarks.

Magnolia Medical is committed to the continued development and successful marketing of innovative products that will transform the way healthcare is practiced around the world. The company supports this effort by offering competitive compensation, incentive packages, benefits, and career growth opportunities to the most qualified candidates in the marketplace. Magnolia Medical Technologies, Inc. is an equal opportunity employer.

For more information, visit magnolia-medical.com