VP of QARA - C&V Product Category

September 16

Apply Now

Receive Emails with Similar Jobs

Integer Holdings Corporation

WebsiteLinkedInAll Job Openings

Medical device outsource (MDO) manufacturer • R&D Capabilities • Transfer to Manufacturing • Manufacturing Process Oversight • Quality/Regulatory

10,000+ employees

Founded 1970

⚕️ Healthcare Insurance

💊 Pharmaceuticals

🧬 Biotechnology

💰 Post-IPO Debt on 2023-01

Description

• The incumbent is responsible for providing the regular Performance Status report outs to the Executive Leadership team for the product category sites and global sites where applicable for all aspects of quality systems, regulatory affairs and compliance in accordance with all industry regulatory standards, customer and Integer standards. • Adheres to and role models Integer Core Beliefs and Guiding Principles and all safety and quality requirements; holds direct reports and team accountable to similar behaviors. • Manage all aspects of the quality and regulatory system across the applicable sites, driving to a standardized system based on best practices. • Is the principal Quality escalation contact and advocate to customers in assigned Product Category and represents Quality in Product Category customer business reviews, executive partnership meetings and customer escalation events, establishing and maintaining customer communications and credibility as the Integer champion. • Interfaces directly and regularly with internal and external customers. • Responsible for projects that are of the highest priority with high visibility by customers. • Proactively manages the risk associated with Quality concerns, including but not limited to design assurance elements of test method validations, sample size selection etc. • Communicates regularly with executive management and administration regarding the management of current projects; obtains executive management guidance and approval as required. • Responsible for success of activities to streamline Quality processes to ensure consistency with Integer Business Systems within the Product Category and alignment with global owners of such Quality System processes. • Drives consistent use of QA/RA KPIs across responsible plants to ensure measured performance improvements based on root cause analysis and defining/ deploying appropriate preventive and corrective actions. • Reviews Quality Agreements for site related agreements in alignment with Global QS and Legal review. • Adheres to the standardized enterprise procedures and controls related to environmental monitoring, sterilization and biocompatibility in accordance with industry, customer and Integer requirements. • Responsible for analyzing site assessment and audit trends to develop best practice processes. • Interviews, hires, and establishes training plans for direct reports. • Provides leadership to the supervisory staff regarding development of individuals’ goals and mentoring of the group. • Able to systematically identify and resolve complex problems with an analytical data driven approach and creative thinking. • Performs other duties as required.

Requirements

• Minimum Education: Bachelor’s in Science, Engineering or a technical discipline. • Master’s degree preferred. • Minimum Experience: 12+ years of experience in Quality Assurance/ Regulatory in a medical device development and manufacturing environment. • Minimum of 10 years of management experience in a medical device development and manufacturing environment with multi-site responsibility. • Special Skills: Establish and maintain networks, influence in a matrixed organization, and communicate in a clearly and highly professional manner. • Demonstrated ability to establish, communicate, and implement long-term strategic and operational goals. • Effectively manage a large workflow and multiple projects at one time. • Strong ability for reasoning and logical deduction and to transfer between abstract and concrete concepts. • In-depth Medical Device Quality Management System knowledge and experience. • Organized and detail oriented, demonstrates a high level of commitment and drive for excellence, and generates enthusiasm. • Experience and expertise applying change management principles and practices to drive successful enterprise transformation. • Demonstrated influencing skills with all levels of key stakeholders during times of transformation and other situations. • Excellent written and oral communication skills. • Strong technical writing skills. • Project management, team development, and management skills. • Knowledge of applicable laws which regulate medical device manufacturers. • Strong leadership skills with demonstrated ability to drive positive results. • Ability to work through difficult issues with suppliers, customers and regulatory bodies.