Senior Manager, Risk Management Process

Werfen•Bedford, MA

About The Position

The Sr. Manager-Risk Management Process is responsible for managing risk processes throughout the product lifecycle, ensuring compliance with ISO 14971 standards, and collaborating with cross-functional teams. This role has responsibilities which include overseeing product quality, process reliability, new product development, validation, assisting with complaint investigations, non-conforming product resolutions, and corrective and preventive actions (CAPA) identifying and solving diverse problems to root cause, and implementing improvements that support business needs and goals. The Sr. Manager- Risk Management Process will for manage technical staff to establish functional goals and meet assigned objectives. The Sr. Manager is accountable for the oversight of activities within the function and for working closely with subordinates by providing regular guidance and general direction to ensure goals are met or exceeded. The position is expected to lead by example in alignment with the company values to achieve objectives.

Requirements

Bachelor’s degree in engineering, Quality Management, Risk Management, or a related field.
Minimum of seventeen (17) years of experience, or thirteen (13) years with advance degree, within a regulated medical device or pharmaceutical environment.
Minimum of five years of risk management experience in the medical device industry, preferably in patient monitoring systems.
Minimum of Five (5) years previous supervisory/management experience required.
Superior knowledge & application of ISO 14971 and TIR 24971 principles
Experience with Systems Engineering-driven processes for ISO 14971 compliance
Must be able to demonstrate successes in quality and process improvements, within a medical device or pharmaceutical environment strongly preferred.
Expert knowledge of quality engineering principles including risk management, software reliability engineering, software validation, root cause investigation, process validation, process capability, trend analysis, statistical methods and metrology.
Excellent project management and problem-solving skills.
Strong planning, analytical, organizational and time management skills are required.
Able to lead and guide a Validation Review Board to implement validation best practices.
Strong leadership abilities required with a focus on collaboration and teamwork.
Expert knowledge of US, EU, and international regulations and guidance documents regarding software for medical devices and IVDs, including compliance requirements, validation standards, and cybersecurity considerations.
Strong understanding of stakeholder requirements, design inputs/outputs, and hazardous situation analysis.
Duties necessitate broad and thorough knowledge of engineering and science theory and principles, including Software Development, AGILE, quality control, manufacturing and design engineering
Computer literacy required; knowledge of Microsoft Office, experience with large enterprise resource planning (ERP) system and statistical software required.
Strong communication skills to all levels of the organization is required (verbal, written, listening and presentation)

Nice To Haves

Master’s degree in engineering, Quality Management, Risk Management, or a related field is preferred.
ASQ Certified CSQE, SSBB, CQE or SQE preferred
QMS lead auditor certificate preferred
Experience with JAMA or other relational databases for requirements management is strongly preferred.

Responsibilities

Lead cross functional discussions with various R&D and other cross functional design team members to ensure that all hazards associated with products are identified, risks are estimated, evaluated, controlled, and documented.
Monitors that risk controls are implemented, verified, and validated for products in development and verify the effectiveness of risk control measures throughout the product life cycle.
Leads periodic reviews of the risk management process and quality system deliverables to ensure ongoing effectiveness and document decisions and actions taken, aligned with quality systems and ensuring compliance with regulatory standards and practices.
Leads remediation efforts for updating risk management documents and the implementation of the various risk processes.
Evaluate estimated risk and acceptability for each risk based on analysis outcomes, utilizing the firm’s risk acceptance criteria. If risks are not acceptable, lead efforts to identify and document risk control methods.
Support the Benefit-Risk Analysis process and lead the evaluation of overall residual risk, ensuring alignment with Werfen’s strategic objectives.
Perform and document Risk Reviews to communicate results of the risk management process to cross-functional teams.
Ensure harmonization of risk management strategies across projects and their lifecycle by communicating with other Risk team members.
Identify opportunities for continuous improvement of the Risk Management Process.
Supports R&D projects with software elements and software tools according to corporate priorities to ensure compliance with procedures and regulations
Support validation and modifications for software used in the production of Werfen products.
Lead internal and external audits for risk-related matters, ensuring compliance with regulatory requirements and industry standards.
Collaborate with software, manufacturing, R&D, and others as required to recommend or implement corrective and preventive actions (CAPA).
Ensure department targets are consistently met or exceeded through the application of best available manufacturing and development practices.
Develop appropriate software quality metrics to identify issues or trends in a timely manner.
Lead improvements to key elements of the Quality Management System that supports long term plans to maximize effectiveness and scalability.
Ensure department targets are consistently met or exceeded through the application of best available manufacturing and development practices.
Make recommendations to management to ensure continued adequacy, suitability, and effectiveness of the QMS.
Lead the Risk team with overall management responsibilities, including hiring, goal setting, professional development, mentoring, training, and performance assessment.
Deploy technically proficient Risk Quality Engineers to provide quality engineering-based deliverables, including software validation, software risk management, testing methodologies, and compliance with regulatory standards.
Establish and manage department budget
Perform other duties as assigned.
Facilitate and provide ongoing training on standards/processes as needed to other associates or functions.
Assist with strategic initiatives and planning.
Mentor and coach other members on the team and cross functional teams on risk management processes.