Director of Quality Assurance
Position Summary: The Director of Quality ensures that the organization’s products and services are in compliance with the company’s quality systems, in addition to complying with customer and regulatory requirements for quality, safety, and reliability. Responsible for establishing strategy, policies and procedures at all levels so quality improvement efforts will meet internal and external customers’ needs and expectations.
Organizational Interactions: Reports directly to the Senior Director of Regulatory/QA. Supervises, trains, and assists all quality assurance personnel. Directs cross-functional quality-related activities in conjunction with Manufacturing, R&D, Clinical, Engineering, Purchasing, Customer Service, and any other department/function that affects the quality of the organization’s goods or services.
- Responsible for the development, implementation, and strict adherence to the Company’s quality program. Develops and/or reviews standards, policies, and procedures for all functions and departments involved with or related to the production of all products.
- Reviews and resolves quality problems/concerns with the appropriate Quality personnel and others including vendors, customers, and any personnel related to production. Coordinates and assists with vendor inspections.
- Ensures quality audits are scheduled and performed, that corrective action plans are implemented and ensures timely resolution of findings.
- Receives and reviews all feedback and customer complaints and ensures resolution in a timely fashion. Reviews feedback/complaint trends and product/component failure analyses; reviews corrective actions with appropriate personnel.
- Prepares reports and other documentation required by regulatory agencies and to support the quality function.
- Develops the quality department staff to establish and maintain a high level of excellence with regard to technical expertise, scientific integrity and regulatory compliance.
- Ensures the promotion and awareness of regulatory and customer requirements throughout the organization.
- Develops and conducts training for employees regarding quality related practices and QMS requirements.
- Builds respectful relationships with cross-functional colleagues and promotes quality mindset across organization.
- Develops and maintains department budget.
- 10+ years in medical device field, with responsibility for a broad spectrum of Quality System elements
- 5+ years guiding and leading quality activities, preferably in a commercial organization
- BS degree (or higher) in the physical sciences, life sciences, or engineering disciplines (physics, chemistry, chemical or biomedical engineering, biochemistry, or biology) or equivalent;
- Broad knowledge of US and OUS quality system requirements, OSHA and other applicable standards of compliance;
- Expertise in all aspects of product life cycle of medical devices with a track record of successful new product launches;
- In-depth knowledge of, and demonstrated experience with, leading cross-functional teams through development, implementation, application, and maintenance of Quality Systems which comply with FDA, QSR, GMP, and related US and international regulations and ISO standards pertaining to IVD development and ongoing commercial manufacturing and delivery;
- Strong team leader and team player with excellent interpersonal and communication skills, and experience working with end-users in a coaching capacity;
- Detail-oriented with strong organizational skills and high quality standards;
- Excellent relationship building and persuasion skills with the ability to motivate and influence others;
- Demonstrated record of overcoming resistance to change, and driving the adoption of new processes from a position of indirect or informal authority;
- Self-motivated, hands-on critical thinker and problem solver, with the ability to lead by example, with an enthusiastic, optimistic outlook, and a collaborative style;
- Ability to integrate and apply feedback in a professional manner.
- Experience in regulatory affairs
- Graduate degree in science
- Ability to travel as required (up to 20% domestic and international)
Physical Job Requirements:
The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer, and communicate with peers and co-workers. Upon request, reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
This job description is intended as a summary of the primary responsibilities of and qualifications for this position. The job description is not intended as inclusive of all duties an individual in this position might be asked to perform or of all qualifications that may be required either now or in the future.
Nuvaira is an affirmative action, equal opportunity employer that values and actively seeks diversity in the workforce.
Apply by sending your resume to [email protected]