Manager, Manufacturing Quality Engineering
Company: Disability Solutions
Location: Boston
Posted on: September 28, 2024
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Job Description:
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.
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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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Keywords: Disability Solutions, Boston , Manager, Manufacturing Quality Engineering, Engineering , Boston, Massachusetts
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