This position will partner cross-functionally across the business with Research and Development, Operations, Sales and Marketing, Clinical and Regulatory Affairs to diagnose and resolve business challenges, analyze data to determine appropriate solutions and integrate quality and risk processes throughout the organization. The Senior. Manager will also be responsible for ensuring the successful completion of individual projects as well as the projects of direct reports.

Responsibilities include:

• Provide Quality Engineering site leadership, expertise and continuous improvement for the Company’s quality management system in accordance with FDA Quality Management System Regulations and ISO standards.
• Support ongoing compliant US commercialization from a quality perspective and facilitate the US launching of new or improved products/processes, and the transfer of technology from research and development or clinical development to commercialization from a Quality and manufacturing perspective. Partner with the Operations, Research and Development, and Regulatory functions to coordinate compliance and develop best practices.
• Critically review QMS documentation for consistency, accuracy and quality ensuring that appropriate information complies with regulatory regulations/standards/guidelines.
• Establish, track, interpret and communicate key quality metrics, processes and policies in an organized and timely manner.
• Develop and implement new and updated Quality System procedures such as SOPs and Work Instructions to support the Quality System.
• Manage QE activities supporting manufacturing within production schedules; including sterilization/dose audits, CER monitoring, overseeing technical aspects of incoming inspection Quality checks.
• Identify, assign, coordinate and monitor performance of product improvement projects in cross-functional teams.
• Prepare or input into validation protocols, manufacturing procedures, product & material specifications, design & development documentation, development, risk management and task force projects.
• Ensure a compliant risk management process for product and processes in accordance with applicable standards.
• Oversee and coordinate CAPA activities, including identification, investigation, implementation, and effectiveness of corrective and preventative actions.
• Utilize Quality Engineering tools and techniques to establish sampling plans, develop quality plans, and conduct process and systems audits and to assist in specification development.
• Conduct statistical analysis (F-test, t-test, ANOVA, normality tests, etc.) and generate trend reports for projects on an as-needed basis.
• Coordinate the reporting, analysis, and resolution of material non-conformance incidences in conjunction with Operations and R&D.
• Oversee Supplier Management as well as plan and conduct supplier quality audits, drive supplier quality initiatives, critically evaluate proposed changes at suppliers and to in-house specifications in conjunction with Operations and R&D.
• Provide end-user onboarding and training on QMS processes and systems to internal stakeholders.
• Champion change management initiatives, ensuring smooth adoption of new processes and system enhancements.
• Serve as QMS subject matter expert (SME) and primary liaison for internal audits, regulatory inspections, and third-party audits.
• Lead resolution of internal and external audit findings and observations, non-conformance reports, and corrective actions.

JOB REQUIREMENTS

Education and Training

• BS in Engineering (preferred), life sciences or other related field.
• Minimum of 5 years of QE work experience in the medical device industry.
• Experience leading and managing a team of quality professionals.

Technical Requirements

Strong experience with FDA requirements, knowledge of regulations such as 21 CFR 820, ISO 13485, ISO14971 and other international regulatory requirements preferred.

• In depth experience with risk management, design control, manufacturing sterile products, sterilization validation and CAPA investigations.
• Strong verbal and written communication skills; must interface well with all levels of the organization.
• Excellent organizational, planning and presenting skills.
• Must work well independently.
• Ability to read and interpret drawings and specifications.
• Ability to write validation protocols and final reports and oversee validations at suppliers.
• Must have initiative, judgment, and ability to manage multiple tasks with frequent interruptions with high attention to detail and accuracy.
• Excellent ability to work in a team environment and display a positive, can-do attitude.
• ASQ CQE (Certified Quality Engineer), and/or Certified Medical Device Auditor certification is preferred.
• Strong work ethic.

Managerial Experience

• Minimum of 5 years prior managerial experience successfully managing technical personnel and complex activities required.