About the Job

The Sr QA Engineer in the Design Assurance department is a key and critical role at FMI. This position works with various teams within FMI. When working with Product Development teams on new product and design changes projects, this role supports deadlines for submission of Bioanalytical plans and reports for Premarket Approvals and supplemental PMAs or IVDR Submissions. Additionally for Biopharma it supports clinical studies and collaborates with the partners on the clinical studies and Good Clinical Practices for the Diagnostic Device. Working with the Lab Operations Quality team, this role supports launch requirements for laboratory activities that provide the insights that directly help doctors match patients to more treatment options. This role also works with the Quality Systems team this role partners with all parts of the organization ensuring that the FMI Quality Management System is dynamic, effective, and compliant creating a competitive advantage for FMI. This position supports the planning and work of multiple project and scrum teams with a big picture mindset, and is accountable for achieving all related business goals.

The Sr QA Engineer in the Design Assurance department is a key and critical role at FMI. This position works with various teams within FMI. When working with Product Development teams on new product and design changes projects, this role supports deadlines for submission of Bioanalytical plans and reports for Premarket Approvals and supplemental PMAs or IVDR Submissions. Additionally for Biopharma it supports clinical studies and collaborates with the partners on the clinical studies and Good Clinical Practices for the Diagnostic Device. Collaborating with the Lab Operations Quality team as needed, this role supports day to day quality management laboratory activities that provide the insights that directly help doctors match patients to more treatment options. When performing quality system updates collaborating with the Quality Systems team this role partners with all parts of the organization ensuring that the FMI Quality Management System is dynamic, effective, and compliant creating a competitive advantage for FMI. This position supports the planning and work of multiple project and scrum teams with a big picture mindset, and is accountable for achieving all related business goals.

Key Responsibilities

• Participate in the development and approval for design and development documents, quality system procedures, and laboratory documentation and controls.
• Be a subject matter expert for audit-related questions within their subject matter area including front room and back room support and management for FDA, Notified Body, or pharma partners.
• Ensure all activities are conducted in compliance with the FMI Quality Management System, appropriate regulations, international and national regulations and are aligned with regulatory agency expectations.
• Effectively collaborate with a fully integrated team to facilitate the completion of documents.
• Maintain Quality Management Systems for functional area including Design Controls, Software Development, Risk Management, Corrective and Preventative Action (CAPA) system and Non- Conforming Material Reports.
• Conduct root cause analysis and implementation of correction, corrective and preventative actions and verification of effectiveness of actions as periodically required in the identification and resolution of issues.
• Other duties as required.

Qualifications

Basic Qualifications

• Bachelor’s Degree in a science or engineering discipline and 5+ years of experience in the medical device, diagnostics, clinical laboratory or biopharmaceutical industry; OR,
• Master's Degree in a science or engineering discipline and 3+years of experience in the medical device, diagnostics, clinical laboratory or biopharmaceutical industry

Preferred Qualifications

• Advanced Degree in the Sciences, Engineering, Business or a related field
• Experience with next generation sequencing methodology
• Experience with IVD, Medical Device product development, analytical validation and product approval, manufacturing and/or lab operations
• Demonstrated ability to lead, communicate, interact and influence effectively at technical levels across functions
• Demonstrated capacity to work in a fast-paced environment with strong attention to detail
• Evidence of knowledge of molecular biology
• Evidence of practical knowledge of standards and regulations pertaining to the medical device industry, both domestic and international; in particular, standards set forth by the International Electrotechnical Commission and International Organization for Standardization
• Deep knowledge of bioanalytical assay development, qualification, and validation requirements that comply with current regulatory standards
• Comprehensive knowledge of Good Manufacturing Practices, Design Controls, Risk Management, Good Clinical Practices and Good Documentation Practices
• Working knowledge of Next Generation Sequencing
• Proficiency in Microsoft Office, Word, Excel, Project and PowerPoint
• Proficiency in relevant analytical methodology and emerging new technologies
• Excellent communication skills and proven ability to work effectively as a member of a multidisciplinary team
• Strong skills in troubleshooting and problem solving
• Understanding of HIPAA and importance of privacy of patient data
• Commitment to FMI values: patients, innovation, collaboration, and passion

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