The primary purpose of this position is to assure quality and complaint manufacturing of medical devices and components by providing oversight of applicable QA/RA processes, establishment of technical direction, and the management of a team of QA/RA Engineers, Specialists, and Technicians. This position serves as the site Management Representative, accountable for the establishment and execution of a quality management system as defined by Integer's Quality policies, FDA QSR, ISO 13485, and the Medical Device Directives. This position will lead and supports quality improvement across the organization.
- 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.
- Acts as site Management Representative.
- Creates a strong and accountable QA/RA team through the coaching and leading of supervisory staff, and the hiring and planned development of team members. Manages subordinates in a manner that fosters a self-directed team approach.
- Establishes and manages departmental strategic, tactical plans, and metrics. Additionally, this function establishes and manages budget to support quality function and Category team requirements.
- Establishes strong peer partnerships and promotes interdepartmental coordination and communication within the matrix organization to drive, support, and ensure successful execution of site strategic objectives.
- Acts as the primary site representative with all customers for operations quality. Maintains effective working relationships with internal and external customers and vendors to establish quality standards prior to initial production, and to resolve technical and business-related quality issues post-production.
- Collaborates with all stakeholders to ensure regulatory requirements are met and risk management considerations are addressed in product development plans.
- Develops, maintains and improves the quality management system in collaboration with global quality systems to ensure compliance to the FDA Quality System Regulation, international requirements such as ISO 13485, and ensures production of finished products meet quality requirements. Interprets and applies new regulations standards and supports process owner on implementation.
- Develops and maintains auditing processes, procedures and activities to maintain compliance with quality standards, customer requirements, and a state of audit readiness at the site.
- Manages the preparation of quality control instructions and procedures, and ensures training is executed.
- Manages the quality engineering function to meet goals and customer expectations.
- Leads and manages the site quality and design assurance functions to assure successful new product design transfer and post-market surveillance by collaborating with the Operations, R&D, NPI, Commercial, and Regulatory functions.
- Reports to senior management on the site progress toward quality targets
- Directs the continued review of quality activities and the creation of new or revised processes to ensure quality improvements reduce costs and enhance efficiency. Provides training and mentoring in Quality improvements techniques to upgrade Associate skills, increase awareness, and improve productivity.
- Incorporates Lean initiatives in support of overall production optimization and Quality initiatives. Ensures Associates participate in continuous improvement efforts and are trained to comply with quality system requirements.
- Investigates, identifies and executes cost effective solutions to various technically related non-conformance problems so that the customers' needs are satisfied.
- Manages and develops regulatory and clinical affairs to successfully liaison with external regulatory, legal, clinical and physician contacts in support of new products, regulatory strategy, post market surveillance, clinical evaluation, and field actions.
- Responsible for overseeing aspects of regulatory support on new product development, post market surveillance, and regulatory reporting requirements for applicable products. Provides regulatory guidance with respect to interactions with Notified Bodies to assure compliance with applicable requirements.
- Performs other duties as required.
Education & Experience:
- Minimum Education: Bachelor's degree in Engineering, Math or Statistics. Master's degree preferred. ASQ certification preferred. Regulatory Affairs Professional Society (RAPS) medical device certification preferred.
- Minimum Experience: 10-12 years of experience in quality or technical functions within the medical device industry, with 3-5 years in managerial experience.
Knowledge & Skills:
- Special Skills: o Excellent written and oral communication skills; ability to communicate effectively to Executive level staff; experience with verbal and written communication to FDA and to customers; strong technical writing skills.
- o Project management, team development, and management skills.
- o Strong leadership skills with demonstrated ability to drive positive results.
- o Ability to work through difficult issues with suppliers, customers and regulatory bodies. Ability to assimilate and analyze information efficiently and apply critical evaluations.
- Specialized Knowledge: o Experience with management of post market surveillance activities.
o Prior experience as a Quality Management Representative.
o Understanding of risk management issues associated with regulated product.
o Experience with Class III/Implantable devices preferred.
o Experience with new product development launch processes preferred.
o Knowledge of applicable laws which regulate medical device manufacturers; experience with ISO, GMP, GDP, and related quality systems.
- Other: Working knowledge of Microsoft Office; Visio and Minitab preferred.