About the Job

The Manager, Manufacturing Quality Engineering in the Quality Assurance department is a key and critical role at FMI. This role presents the incumbent with an opportunity to lead various teams within FMI. The Manager is responsible for oversight and management of the Quality Assurance manufacturing team in Boston, MA with a global mindset ensuring continuity across all manufacturing sites. This position leads various teams within FMI, directing quality personnel working with manufacturing and IVD operations teams within the Quality System Program, including manufacturing process review, batch release of products, IVD assay validation and verification, manufacturing material acceptance, device non-conformance and CAPA investigation. Overseeing quality deliverables in area of assignment and expertise while maintaining a competitive advantage for FMI. This position supports the planning and execution for multiple projects with a big picture mindset and is accountable for achieving all related business goals. When working with Product Development teams on new products and design changes projects associated with manufacturing of materials, reagents and instruments, the incumbent serves as a representative of the Design Assurance Quality pillar. This role supports teams and project deadlines for submissions for Premarket Approvals and supplemental PMAs or IVDR Submissions.

Key Responsibilities

• Lead teams participating in the development and approval of design and development documents, quality system procedures, and manufacturing documentation and controls. 

• Subject matter expert and strategist for audit-related questions within their subject matter area and beyond, 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. 

• Direct programs or procedures which assure the proper compliant manufacturing, the timely data analysis and reporting of trends and the completion of written investigations in response to unusual or unexpected results or deviations. 

• Perform manufacturing batch and manufacturing material review and release.

 • Assist with the expansion of the manufacturing program in compliance with IVDR, ISO 13485, and pertinent regulatory bodies. 

• Effectively collaborate with a fully integrated team to facilitate the completion of documents. 

• Lead Root Cause Analysis (RCA), Design of Experiments (DOE), Corrective and Preventative Action (CAPA), LEAN, and similar continuous improvement initiatives with a solution-focused mindset. 

• Maintain Quality Management Systems for functional areas including Design Controls, Production and Process 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. 

• Guide the organization on strategy and implementation of continuous improvement of the quality system. 

• Management of quality professionals, including ensuring activities are completed aligned with goals and continuous personnel development. 

• Provides training and mentorship to less experienced members of QA staff across the QA organization. 

• Other duties as required.

Qualifcations

Basic Qualifications

 • Bachelor’s Degree in sciences or engineering discipline 

• 5+ years of experience in medical device, diagnostics, clinical laboratory, or biopharmaceutical industry 

• 1+ years of management experience 

Preferred Qualifications 

• 3 years of management experience 

• Bachelor’s Degree in sciences or engineering discipline

 • Experience with next generation sequencing methodology

 • Evidence of knowledge of molecular biology 

• Experience with IVD, or Medical Device product development, analytical validation and product approval 

• 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 

• Demonstrate ability to lead, communicate, interact and influence effectively at technical levels across functions

 • Proficiency in Microsoft Office, Word, Excel, Project and PowerPoint

 • Deep knowledge of bioanalytical assay development, qualification, and validation requirements that comply with current regulatory standards

 • Proficiency in relevant analytical methodology and emerging new technologies 

• Strong skills in troubleshooting and problem solving 

• Comprehensive knowledge of Good Manufacturing Practices, Design Controls, Risk Management, Good Clinical Practices and Good Documentation Practices 

• Excellent communication skills and proven ability to work effectively as a member of a multidisciplinary team • Demonstrated capacity to work in a fast-paced environment with strong attention to detail

 • Working knowledge of Next Generation Sequencing.

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