This position includes responsibilities related to CAPA and Medical Device Risk Management (RM) such as managing CAPA Intake, Investigations, Actions, Effectiveness Monitoring, as well as all all aspects of Risk Management.
This position includes responsibilities related to CAPA and Medical Device Risk Management (RM) such as managing CAPA Intake, Investigations, Actions, Effectiveness Monitoring, as well as all aspects of Risk Management: dFMEA input, hazard analysis, risk assessments/reviews/reports, risk mitigation, and residual risk assessments.
Develop and promote the Candela Medical RM processes including management and maintenance of global policies and procedures;
Create, manage, and maintain device risk management files and associated documentation in accordance with the requirements of ISO 14971, global regulatory requirements, and company policies/procedures.
Facilitate and lead Periodic Risk Review activities for all product lines.
Establish processes for periodic review/update of FMEA Probability of Occurrence rankings to ensure mitigations are still adequate or to drive development of improved mitigations/risk controls.
Assist in the generation of health hazard evaluations (HHE) to appropriately document and disposition patient and/or user health hazards arising from product complaints and/or non-conformances.
Function as the global representative for Candela Medical RM processes during Agency Inspections/3rd Party Audits. Assist in the preparation and submission of audit/inspection responses and requests for information (i.e. FDA, Notified Body and other Regulatory Bodies).
Collect and analyze product design and quality data to facilitate generation of lessons learned, improvement of processes, and assurance of patient safety;
Participate in all phases of risk management processes…Design Feasibility through Product Retirement.
Provide guidance and support to design and manufacturing teams in the generation of risk source documentation (i.e. dFMEA, pFMEA, Fault Tree Analysis, etc.).
Ability to assess Quality System (Compliance) Risk in addition to Product Quality Risk.
Establish cross functional relationships and partner with all levels of management to ensure business/product initiatives are realized.
Partner with GRD and Sustaining Engineering maintains a master inventory of Design Control projects, status, phase gate performance, costs, etc for Executive Management.
Works independently after general instructions are given on assignments.
Performs trend analysis of quality data associated with Candela products and recommends corrective/preventive actions for problem resolution.
Mentors other staff as applicable.
Monitors and prioritizes business need in order to complete and close all activities in a timely manner.
Maintains knowledge of all processes and quality principles to assist with daily operations and continual improvement activities.
Other projects as assigned by direct Supervisor.
Bachelor’s Degree required in a scientific or engineering discipline; Advanced Degree desirable.
Professional quality discipline certifications desired, (CQE, CQA, CQM or RAB). Six Sigma certification preferred.
Minimum 5 – 8 years of CAPA/Risk quality systems engineering experience in a highly regulated industry; with a Master’s Degree 3 years of experience is acceptable.
Experience within the areas of quality engineering, regulatory affairs, quality assurance management, change control, or configuration management desired.
Ability to understand and employ mathematics at an engineering or scientific level.
Experience in project management and risk management (such as FMEA, FTA, FMECA) tools are highly desirable.
Experience in working with Medical Device Risk Management (Specifically ISO 14971), CAPA, Complaint Management, and Nonconformance Reporting required.
Frequent use and general knowledge of industry practices, techniques, and standards. General application of concepts and principles.
Develops solutions to a variety of problems of moderate scope and complexity. Refers to policies and practices for guidance.
Works under very general supervision. Work is reviewed for soundness of judgment and overall adequacy and accuracy.
Knowledgeable of FDA and ISO guidelines for the development of medical devices required.
Manufacturing process knowledge preferred.
Excellent oral and written communication skills preferred.
Working knowledge of risk management requirements.
Working knowledge of risk management requirements, device clinical use, and associated harms and hazards.
This job description is not all inclusive and is intended to capture a majority of the job functions. Special projects and other tasks may be required by management.