About the Job
The Quality Engineer II in the Quality 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. As part of the lab operations quality team, this role supports day to day quality management laboratory activities that provide the insights that directly help the doctors match patients to more treatment options. Within 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 Quality Engineer II in the Quality Assurance department is a key and critical role at FMI. This role will present the incumbent with an opportunity to work with various teams within FMI. When working with Product Development Teams on new product and design change projects, this position will support deadlines for submission of Bioanalytical plans and reports for Premarket Approvals and supplemental PMAs. As part of the Lab Operations Quality team, this position will be supporting day-to-day quality management laboratory activities that provide the insights that directly help the doctors match patients to more treatment options. Within the Quality Systems team, this role will partner 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
1. Participate in the development and approval for design and development documents, quality system procedures, and laboratory documentation and controls.
2. 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.
3. 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.
4. Effectively collaborate with a fully integrated team to facilitate the completion of documents.
5. 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.
6. 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.
7. Other duties as required.
Qualifications
Basic Qualifications
8. 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,
9. 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
10. Advanced Degree in the Sciences, Engineering, Business or a related field
11. Experience with next generation sequencing methodology
12. Experience with IVD, Medical Device product development, analytical validation and product approval, manufacturing and/or lab operations
13. Demonstrated ability to lead, communicate, interact and influence effectively at technical levels across functions
14. Demonstrated capacity to work in a fast-paced environment with strong attention to detail
15. Evidence of knowledge of molecular biology
16. 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
17. Deep knowledge of bioanalytical assay development, qualification, and validation requirements that comply with current regulatory standards
18. Comprehensive knowledge of Good Manufacturing Practices and Good Documentation Practices
19. Working knowledge of Next Generation Sequencing
20. Proficiency in Microsoft Office, Word, Excel, Project and PowerPoint
21. Proficiency in relevant analytical methodology and emerging new technologies
22. Excellent communication skills and proven ability to work effectively as a member of a multidisciplinary team
23. Strong skills in troubleshooting and problem solving
24. Understanding of HIPAA and importance of privacy of patient data
25. Commitment to FMI values: Integrity, Courage, and Passion
#LI-Onsite