Director of Quality Assurance and Compliance
React Health, Bothell, Washington, United States, 98021
POSITION : Director of Quality Assurance and Compliance
FULL-TIME/PART-TIME : Full Time
LOCATION : Bothell, WA OR Dublin, OH
GENERAL SUMMARY 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.
QUALIFICATIONS
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
Preferred Education
Master's Degree in Engineering, Quality Assurance, Manufacturing, or Business Administration
Preferred Experience
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.
Physical Demands
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.
Working Conditions
Predominantly operates in an office environment. Some work (less than 5%) requires moving and lifting heavy networking equipment.
DUTIES AND ESSENTIAL FUNCTIONS
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, process maps, procedures, and tools in compliance with all applicable industry, local, national, and international regulatory requirements, and standards.
Act as Quality Management Representative and liaison with regulatory bodies regarding compliance and complaint reporting. Serve as the primary contact for regulatory agency and 3rd party interactions for Company products, including site visits, audits and inspections.
Develop, lead and collaborate for FDA-483 or Warning Letter remediation activities per plan.
Work closely with Marketing, Engineering, Manufacturing, Service, and other internal and external partners to ensure effective, efficient, and well-established Quality & Compliance processes.
Provides customer focused interactions.
Provide directions to team responsible for quality process improvements, corrective actions, complaint analysis, and risk management.
Strong understanding of regulatory requirements of US and International markets.
Gain cross-functional alignment to establish new processes and implement effective change management.
Continuously seek innovative ways to improve business productivity through introduction of new quality system technologies, methods and controls.
Establish product quality and process metrics that effectively measure and improve performance.
Promote best practices to design, develop and manufacture products that will meet and exceed customers' expectations.
Develop and execute a strategic vision for the Quality Management System aligned with the company's long-term objectives.
Report to Executive Management on status, suitability, and effectiveness of Quality System, including quality policies and objectives through Management Review process.
Develop and effectively manage operating, staffing, and projects budgets.
Manage full-time or temporary resources based on work level demands and budgetary constraints.
Plan and execute staffing and compensation decisions.
Provide leadership to coach and mentor and retain a knowledgeable and competent staff that is effectively organized to deliver high quality service to users, meet time commitments.
Foster an environment which motivates the achievement of desired business results.
Attend and participate in departmental meetings.
Attend seminars and training sessions necessary to maintain appropriate level of professional competence.
Ensure all department compliance guidelines are met.
Attend all meetings, in-services training, or continuing education as delegated by the supervisor.
Performs all duties necessary for the department as per department policies and procedures.
Performs other duties and responsibilities as delegated by the supervisor within the scope of practice and the responsibilities in the department. Minimal travel required.
Reasonable accommodations may be made to accommodate individuals with disabilities to perform the basic functions of the position without compromising client care.
React Health is an Equal Opportunity/Affirmative Action Employer and is committed to providing a drug‑free workplace. We are an Equal‑Opportunity Employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity, status as a veteran, and basis of disability or any other federal, state, or local protected class.
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GENERAL SUMMARY 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.
QUALIFICATIONS
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
Preferred Education
Master's Degree in Engineering, Quality Assurance, Manufacturing, or Business Administration
Preferred Experience
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.
Physical Demands
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.
Working Conditions
Predominantly operates in an office environment. Some work (less than 5%) requires moving and lifting heavy networking equipment.
DUTIES AND ESSENTIAL FUNCTIONS
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, process maps, procedures, and tools in compliance with all applicable industry, local, national, and international regulatory requirements, and standards.
Act as Quality Management Representative and liaison with regulatory bodies regarding compliance and complaint reporting. Serve as the primary contact for regulatory agency and 3rd party interactions for Company products, including site visits, audits and inspections.
Develop, lead and collaborate for FDA-483 or Warning Letter remediation activities per plan.
Work closely with Marketing, Engineering, Manufacturing, Service, and other internal and external partners to ensure effective, efficient, and well-established Quality & Compliance processes.
Provides customer focused interactions.
Provide directions to team responsible for quality process improvements, corrective actions, complaint analysis, and risk management.
Strong understanding of regulatory requirements of US and International markets.
Gain cross-functional alignment to establish new processes and implement effective change management.
Continuously seek innovative ways to improve business productivity through introduction of new quality system technologies, methods and controls.
Establish product quality and process metrics that effectively measure and improve performance.
Promote best practices to design, develop and manufacture products that will meet and exceed customers' expectations.
Develop and execute a strategic vision for the Quality Management System aligned with the company's long-term objectives.
Report to Executive Management on status, suitability, and effectiveness of Quality System, including quality policies and objectives through Management Review process.
Develop and effectively manage operating, staffing, and projects budgets.
Manage full-time or temporary resources based on work level demands and budgetary constraints.
Plan and execute staffing and compensation decisions.
Provide leadership to coach and mentor and retain a knowledgeable and competent staff that is effectively organized to deliver high quality service to users, meet time commitments.
Foster an environment which motivates the achievement of desired business results.
Attend and participate in departmental meetings.
Attend seminars and training sessions necessary to maintain appropriate level of professional competence.
Ensure all department compliance guidelines are met.
Attend all meetings, in-services training, or continuing education as delegated by the supervisor.
Performs all duties necessary for the department as per department policies and procedures.
Performs other duties and responsibilities as delegated by the supervisor within the scope of practice and the responsibilities in the department. Minimal travel required.
Reasonable accommodations may be made to accommodate individuals with disabilities to perform the basic functions of the position without compromising client care.
React Health is an Equal Opportunity/Affirmative Action Employer and is committed to providing a drug‑free workplace. We are an Equal‑Opportunity Employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity, status as a veteran, and basis of disability or any other federal, state, or local protected class.
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