Oversee and manage all department activities within the Quality Assurance Department.
Maintain knowledge of quality standards and regulations including proposed and final rules.
Lead external audits/inspections (preparation, execution, and responses).
Ensure that quality management system requirements are effectively established and maintained.
Enforce compliance with regulatory requirements through internal and external auditing and maintain evidentiary records by supporting procedure development, implementation, and reviews appropriate to the organization.
Collect, analyze, and trend quality data.
Ensure robust investigations and solutions are developed as part of the Quality Systems processes.
Act as Quality Approver for quality records and final release of product.
Manage customer complaint files to ensure global regulatory compliance including the review for possible adverse events and MDR.
Manage CAPA (corrective and preventive action) and focus on continuous improvement and customer satisfaction.
Evaluate, monitor, and audit vendors.
Review and approve supplier’s documentation and records (e.g., quality plans, process validations, etc.).
Ensure that team members are trained to the organization’s processes and necessary standards.
Ensure that audits of the quality system are performed in an efficient, timely and complete manner.
Report to top management on the performance of the quality management system and ensure the promotion of awareness of regulatory requirements throughout the organization.
Participate in design reviews for new products.
Bachelor Degree required, preferably in a technical discipline or possess a technical aptitude.
5+ years of quality management experience.
1+ years of management or leadership of people or projects with the ability to work within cross-functional teams.
A working with medical devices (preferably class II and class III).
Strong knowledge of ISO13485, 21 CFR Part 820, EU MDR 2017/745, and MDSAP.
Detail oriented, hands-on manager.
Experience with new product development or engineering highly preferred.
Strength in data analysis, trending, and forecasting of numbers.
Ability and interest in “rolling up sleeves” to perform “hands-on” quality.
Flexibility and ability to self-start on new challenges, problem-solving with minimal supervision.
Ability to work efficiently on multiple tasks with deadlines in a small company where job duties/priorities may change.
Ability to work in a diverse team with members of varying education and experience levels.
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