Director of Quality Assurance and Compliance

POSITION
:
Director of Quality Assurance and Compliance
FULL-TIME/PART-TIME
:
Full Time
LOCATION
:
Bothell, WA OR Dublin, OH

The Director Quality Assurance and Compliance is a highly motivated, technically competent team builder who can establish and execute a strategic vision, multi-task in a fast-paced work environment, and deliver tangible results for the React Health facility for Class I and II products. The Director will lead and manage the Quality Assurance and Compliance functions to ensure operational compliance with government regulations (FDA-Quality System Regulation, and other applicable country specific regulations) and applicable standards (MDSAP, ISO 13485, etc.).

This position is responsible for leading and executing the global quality systems and regulatory compliance strategy for React Health. Responsibilities include managing the planning and implementation of the company quality management system (QMS) and regulatory compliance; quality system integration; creation and implementation of corporate processes, process maps, procedures, and tools; management of internal audits, ISO audits and government agency inspections; management of document control activities, management, and implementation of corporate quality tools, QMS training, Product Vigilance and Complaint Handling.

A proven track record of work experience and success in medical device manufacturing and distribution companies. Other essential skills include: the ability to recognize logistical problems and initiate appropriate solutions; problem- solving capability with a solid understanding of scientific data collection, analytics and management methods; and excellent interpersonal verbal and written communication skills. The position reports to the VP, Quality & Regulatory Affairs.

• 15+ years of experience in Quality/Regulatory in FDA regulated company, and experience with ISO 13485, ISO 14971 Risk Management, FDA’s QSR for medical devices, relevant applicable ISO Standards, International Regulations
• Minimum of 7 years of leadership experience is required
• Bachelor’s degree in Engineering, Quality Assurance, Manufacturing, or Business Administration
• Change leadership, coaching, managing multiple priorities, problem solving, Project Management

• Master's Degree in Engineering, Quality Assurance, Manufacturing, or Business Administration

• CQE, CMQ/OE, CQA, regulatory study degree/certification and Quality systems auditor preferred
• Knowledge of QA document processes and systems, failure mode and effects analysis, statistical tools including statistical process control, and product vigilance and complaint handling
• Strong knowledge of domestic and international regulatory requirements (i.e. FDA, GxPs, and ISO/EN standards).
• Excellent communications and interpersonal relationship skills including negotiating and relationship management with the ability to drive achievement of objectives. Must have proven ability to lead a diverse team of Quality Assurance and Complaint Management personnel. Excellent communication skills and the ability to work well with cross-functional teams at all levels are essential.
• Must be able to demonstrate strong organizational and managerial skills.
• Capability of working independently, taking ownership for the management of processes, projects and timelines.
• Ability to effectively influence affiliates, regulatory agencies, and internal and external partners to ensure that business needs are met.

• Requires normal visual acuity and hearing.
• Typically, employees sit comfortably to do their work, interspersed by brief periods of standing, walking, bending, carrying papers and books, and extensive periods requiring the use of computer terminals to accomplish work objectives.
• Required to sit and use their hands and fingers to handle or feel and manipulate keys on a keyboard.
• Additional skills may be required to perform additional task(s) specific to work location, department or line of business.

• Predominantly operates in an office environment. Some work (less than 5%) requires moving and lifting heavy networking equipment.

• Member of site Senior management staff, providing representation for Quality functions and personnel.
• Direct Quality Assurance & Compliance, Quality Systems, and Complaint management functions.
• Identify and lead continuous development and implementation of global quality and regulatory compliance strategy.
• Lead development and maintenance of robust Quality Management System (QMS) that adheres to Good Manufacturing Practices (GMP) and regulatory requirements.
• Select and maintain best practice and compliant quality systems and processes in support of global quality policy.
• Monitor technological trends such as emerging standards and new technology opportunities.
• Manage planning and implementation of the Quality Management System (QMS), including creation and implementation of corporate processes,…