Senior Manager, Risk Management Process

Job Summary

The Sr. ManagerRisk Management Process is responsible for managing risk processes throughout the product lifecycle ensuring compliance with ISO 14971 standards and collaborating with crossfunctional teams. This role has responsibilities which include overseeing product quality process reliability new product development validation assisting with complaint investigations nonconforming 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 byproviding 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.

Key Accountabilities

• 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 firms risk acceptance criteria. If risks are not acceptable lead efforts to identify and document risk control methods.
• Support the BenefitRisk Analysis process and lead the evaluation of overall residual risk ensuring alignment with Werfens strategic objectives.

• Perform and document Risk Reviews to communicate results of the risk management process to crossfunctional 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 riskrelated 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 engineeringbased 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.

Networking/Key relationships

• Software Engineering
• Manufacturing Operations
• Manufacturing Engineering
• Regulatory Affairs
• Product Quality & Customer Satisfaction
• Research & Development
• Service

Minimum Knowledge & Experience required for the position:

• Bachelors degree in engineering Quality Management Risk Management or a related field.
• Masters degree in engineering Quality Management Risk Management or a related field is preferred.
• 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.
• ASQ Certified CSQE SSBB CQE or SQE preferred
• QMS lead auditor certificate preferred

Skills & Capabilities:

• Superior knowledge & application of ISO 14971 and TIR 24971 principles
• Experience with Systems Engineeringdriven 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 problemsolving 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.
• Experience with JAMA or other relational databases for requirements management is strongly preferred.
• Strong communication skills to all levels of the organization is required (verbal written listening and presentation)

Travel requirements:
Less than 5 percent