Senior Manager, Operational Area Quality - Devices (Hybrid)

Job Description

General Summary :

The Operational Area Quality Senior Manager will provide quality assurance management for design and development, quality systems and compliance activities working cross-functionally within Vertex.

Key Duties and Responsibilities :

• Provides quality assurance management in design and development activities of medical device products and facilitates the application of design controls and risk management.
• Support Design History File establishment, creation, approval and maintenance.
• Perform Design History File audits at Phase Gates to ensure product development projects are in compliance to applicable design control regulations (21 CFR 820) and company policies and procedures.
• Review and approve design documentation including, but not limited to verification and validation methods, test plans, protocols and reports, test and inspection documents, design engineering drawings, statistical analysis methods, and risk documents (design and process).
• Support risk management activities including planning, design and clinical risk management DFMEA, production risk management PFMEA, and overall risk summary reporting.
• Provides support for vendor management in the US and with international vendors.
• Manage risk management file throughout product development cycle.
• Review new and modified product designs for quality characteristics, including manufacturability, testability, reliability, biocompatibility, sterility and conformance to product requirements.
• Apply statistical methods and design / process excellence tools to support design engineering rationales / memos as required.
• Provide leadership in all areas of the Quality System, including, but not limited to Root Cause Analysis, CAPA, Nonconforming Material Investigations and Reporting, Deviations, Change Control, Supplier Qualifications, and Audit support functions (internal and external).
• Provide leadership in the understanding and communication of medical device regulations to other disciplines.
• Know and follow applicable FDA regulations and policies that apply to one’s job, and maintain the highest level of professionalism, ethics and compliance at all times.

Knowledge and Skills :

Direct Hands-on experience in Medica Devices Quality and Compliance Life Cycle Management, for COMBO products and Auto Injector

• Acted as QA Technical Subject Matter Expert in global Regulatory Inspections and ISO 13485 Certification
• Created, authored, and successfully closed Medical Device Complaint Management
• Created and implemented Medical Devices Policies and Procedures for Class II and III devices in accordance to global regulatory requirements
• Reviewed and released executed batch records for assembly of Pre-Filled Syringe into Auto Injector manufacturing.
• In-depth knowledge and experience in QC and Functional Testing, Design and Design Validation of class II and III medical dev i ces
• Demonstrated knowledge of quality engineering, GMPs, QSR (21 CFR 820), Change Control, Supplier Quality, Design Control and Vendor Management.
• Possess excellent problem solving, decision-making, and root cause analysis skills in addition to interpersonal skills that foster conflict resolution as it related to technical situations.
• Strong written and verbal communication skills are required, as is the ability to effectively communicate with cross-functional teams and program managers.
• Highly detail oriented with strong organization and prioritization skills.
• Proficiency utilizing MS Office Suite (Word, Excel, PowerPoint etc.)
• Practical knowledge and experience with statistical methods, including sampling size justification using Minitab or other statistical software
• Development and / or manufacturing experience
• ASQ certifications (Certified Quality Engineer, Certified Quality Auditor, Six Sigma)
• Working knowledge of ISO 13485, ISO 14971 and combination product standards
• Blueprint literacy including GD&T

Education and Experience :

• Bachelor's degree in relevant field is required
• Typically requires 6 years of experience or the equivalent combination of education and experience

Other Requirements

15% Travel may be required.

Hybrid-Eligible Roles

In this Hybrid-Eligible role, you can choose to be designated as :

Hybrid : work remotely up to two days per week; or select On-Site : work five days per week on-site with ad hoc flexibility.