Integer's Power Solutions group in Beaverton,OR is looking to add a Quality Assurance Manager to their team which will report to the Director of Quality. Power Solutions focuses on the development and manufacturing of power sources for medical devices. If you're looking to work for a high performance based, growing organization, within a growing industry in the medical device space this is an exciting career opportunity. The primary purpose of this position is to assume responsibility for the planning and management of a Design Center Quality Team, which includes Quality Systems and Design Assurance. This position will manage a team to meet site/organizational goals and customer expectations. Responsible for providing metrics and leadership for implementing and achieving Quality objectives.
Adheres to Integer’s Values and all safety, environmental, security and quality requirements including, but not limited to: Quality Management Systems (QMS), Safety, Environmental and Security Management Systems, U.S. Food and Drug Administration (FDA) regulations, company policies and operating procedures, and other regulatory requirements.
Maintains safe and ethical business practices and adheres to Integer’s Quality Policy.
Maintains effective working relationships with internal and external customers and vendors to establish quality standards prior to design transfer, and to resolve technical and business-related quality issues post-commercialization.
Establishes and manages departmental goals, tactical plans, and metrics.
Promotes interdepartmental coordination and communication to ensure successful execution of the Integer Quality Strategy.
Performs other duties as required.
Manages and sets priorities of the Design Assurance Engineer(s) and Quality Technician(s).
Maintains and improves the design control and risk management processes to ensure compliance to the FDA Quality System Regulation, international requirements such as ISO 13485, and to ensure the design of finished products and/or components that meet quality requirements.
Leads the Design Assurance function to assure successful new product design transfer by collaborating with the Research and Development and Operations functions.
Ensures the following activities occur in accordance with current procedures: test method development & validation, finished products verification, component verification, validation as part of transfers to production and design reviews.
Responsible for the continued review of design assurance activities and processes to ensure effective design controls, risk containment, cost reduction and enhance efficiency.
Manages and sets priorities of the Quality System Specialists
Responsibilities over CAPA, Document Control, Internal Audit, Management Review, and Training
Promotes and maintains alignment of Site QMS Documents with QMS Enterprise Policies.
Participates and/or leads project teams for the implementation of enterprise and site Quality objectives.
Organizes and provides training and mentoring for quality improvements to enhance Associate skills, increase awareness, and improve productivity.
Interviews, hires, and establishes training plans for direct reports. Provides leadership regarding development of individuals’ goals as well as providing mentoring of the group.
Manages team in a manner that fosters a self-directed and collaborative team approach.
Facilitates communication, coordination and conflict resolution within and among work groups.
Education & Experience:
Minimum Education: Bachelor’s degree in engineering or related field required.
Minimum Experience: 5 years minimum of related experience in quality, design assurance and/or design & development.
Knowledge & Skills:
Special Skills: Collaborative, Task Driven, Team Player, MiniTab, Office Suite, problem solving techniques.
Specialized Knowledge: Knowledge of ISO and FDA qualitysystem requirements, design controls, risk management, and process validation. CAPA, Document Change Management, NCR, and Statistical Expertise required.
Other: ASQ Certifications would be a plus
Internal Number: R5819
About Integer Holdings Corporation
Integer represents a new dimension in the medical device outsource industry. Its comprehensive product continuum helps customers advance devices from early stage funding to commercialization. Formed from the merger of Greatbatch™, Lake Region Medical™ and Electrochem™ – together, we are Integer.
Our medical device brands represent the quality and innovation that is the legacy of Greatbatch and Lake Region Medical. Now, with comprehensive capabilities, many medical device companies worldwide consider Integer the partner of choice for innovative technologies and services in: Cardiac Rhythm Management & Neuromodulation, Cardio & Vascular, Power Solutions, and Electrochem.
Our extensive product development process complements our customer’s approach. Whether it’s a medical device or non-medical application, experience Integer’s commitment to innovation, quality and speed-to-market in: Research Design & Development, Manufacturing Transfer Program, Medical Device Manufacturing, or Quality & Regulatory Standards.