Director, Quality Engineering at Rise Real Estate

Bothell, Washington, United States -

Full Time

Start Date

Immediate

Expiry Date

11 Jun, 26

Salary

230000.0

Posted On

13 Mar, 26

Experience

10 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Team Building, Strategic Vision, Risk Management, Process Mapping, Data Collection, Analytics, Problem Solving, Communication, Change Leadership, Coaching, Project Management, Negotiating, Relationship Management, Audit Management, Attention To Detail, Organizational Skills

Industry

Description

POSITION: Director, Quality Engineer FULL-TIME/PART-TIME: Full Time LOCATION: Bothell, WA React Health is a fast-paced, growth-driven manufacturer and distributor of medical equipment, dedicated to supporting patients, caregivers, physicians, and healthcare providers. With a focus on respiratory and sleep health sectors, we offer a comprehensive range of products and services across acute care, non-acute care, and home medical equipment. By integrating manufacturing and distribution, React Health addresses the needs of both undiagnosed individuals and those requiring therapy after diagnosis, particularly within the sleep and respiratory care sectors. GENERAL SUMMARY The Director of Quality Engineering 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 Engineering function to ensure operational compliance with government regulations (FDA-Quality System Regulation, and other applicable country specific regulations) and applicable standards. This position is responsible for leading and executing the Quality Engineering strategy for React Health. Responsibilities include managing the planning and implementation of the use, design and process (internal and external) risk management and integration; creation and implementation of corporate processes, process maps, procedures, and tools. A proven track record of work experience and success in Class II 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 Assurance & Regulatory Affairs. QUALIFICATIONS * 15+ years of experience in leadership in quality/regulatory in FDA regulated company, including Supplier Quality, Design Quality and Process / Manufacturing Quality Engineering functions * Bachelor’s degree in Engineering * 15+ years’ experience with ISO 13485, ISO 14971 Risk Management, FDA’s QSR for medical devices, Relevant applicable ISO Standards, MDR, Health Canada Regulations, and other International Regulations * Change leadership, coaching, team development, managing multiple priorities, problem solving, Project Management * CQE certification preferred Preferred Education * Master’s degree in Engineering Preferred Experience * Knowledge of QA document processes and systems, Design of Experiments (DOE), process capability studies, failure mode and effects analysis, and statistical tools including statistical process control. * 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. * Proven ability to lead a diverse team of technicians and engineers. * Excellent communication skills and the ability to work well with people at all levels are essential. * 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. * Experience in leading and managing external audits and inspections * Excellent attention to detail and project management skills. * Excellent written/oral communication skills required. Must be able to work effectively with diverse groups of people. 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 of heavy networking equipment. DUTIES AND ESSENTIAL FUNCTIONS Each Employee consistently demonstrates the following essential functions: * Member of site Senior management staff, providing representation for all Quality Engineering functions and personnel. * Direct Quality Engineering functions (Supplier Quality, Design Quality and Process / Manufacturing Quality. * Identify and lead continuous development and implementation of Quality Engineering strategy. * Select and maintain best practice and compliant quality systems and processes in support of the global quality policy. Monitor technological trends such as emerging standards and new technology opportunities. * Manage the planning and implementation of the Quality Engineering functions, including the 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. * Work closely with Marketing, Engineering, Manufacturing, Service, Suppliers, and other internal and external partners to ensure an effective, efficient, and well-established Quality Engineering processes. * Provide direction to the team responsible for pre- and post-market quality engineering activities; use, design and internal and external process risk management such as FMEAs, test method validation, process improvements, non-conformance investigation and product disposition, corrective action, complaint analysis, etc. * Gain cross-functional consensus, where possible, to establish new processes and implement effective change management. * Continuously seek innovative ways to improve business productivity through the 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. * Manage needs for full-time or temporary Quality Engineering resources based on work level demands and budgetary constraints. Plan and execute staffing and compensation decisions. * Develop and effectively manage operating, staffing, and projects budgets. * Provide leadership to ensure the Quality Engineering organization attracts coaches and mentors and retains 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. * Attends and participates in departmental meetings, attends seminars and training sessions necessary to maintain appropriate level of professional competence. * Ensures all department compliance guidelines are met. * Provides customer focused interactions. * 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. * Attends and participates in departmental meetings. * Attends seminars and training sessions necessary to maintain appropriate level of professional competence. * Ensures all department compliance guidelines are met. * Follow evidence base standards of medical care through adherence to existing policies and procedures. * Attends all meetings, in-services training, or continuing education as delegated by the Vice President. * Provides customer focused interactions. * 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. 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.

Responsibilities

The Director will lead and manage the Quality Engineering function to ensure operational compliance with government regulations like the FDA-Quality System Regulation and applicable standards for Class I and II medical devices. Responsibilities include managing the planning and implementation of risk management, and creating and implementing corporate processes, process maps, and procedures.