Senior Quality Manager, CAPA & NC

Integra LifeSciences•Princeton, NJ

About The Position

Changing lives. Building Careers. Joining us is a chance to do important work that creates change and shapes the future of healthcare. Thinking differently is what we do best. To us, change equals opportunity. Every day, our colleagues are challenging what’s possible and making headway to innovate new treatment pathways to advance patient outcomes and set new standards of care. SUMMARY The Senior Quality Manager, CAPA and Nonconformances (NC) has responsibilities to develop and lead the implementation plan of Integra’s Global Quality Management System Compliance Processes (CAPA and Nonconformances). Work with process and Quality Operations leadership to drive consistent best practices for CAPA and NC, Management Review and Metrics and establish global oversight. Deploy CAPA and NC processes and digital systems that improve compliance, efficiencies, and overall effectiveness. Responsible for partnering with global quality leaders to develop processes and metrics that result in attaining the company’s improvement objectives and growth strategies.

Requirements

Bachelor’s degree is required, preferably in a scientific or engineering discipline.
10+ years of demonstrated quality experience in the medical product and device industry with strong concentration in US FDA QMSR and ISO 13485 compliance and quality assurance.
Proficient understanding and demonstrated practical application of medical device regulations which include CAPA, NC and Metrics.
Experience with communicating with domestic and international regulatory bodies.
Strong analytical, strategic, decision making, and risk assessment abilities.
Ability to effectively collaborate with process owners and stakeholders in corporate, division and site
Highly developed technical writing and editing skills.
Excellent organizational, leadership, and interpersonal skills.
Proficient in the following computer software applications: Microsoft Office, Copilot
Exceptional interpersonal skills.
Strong organizational and communication skills (written and verbal).
Ability to travel domestically and internationally as business required.
Experience in FDA regulated environment.
Ability to interface with technical and non-technical personnel.
Ability to utilize a computer, telephone, smart phone as well as other general office equipment.
Strong computer skills are required.

Responsibilities

Establish and maintain the Corporate CAPA board to address company-wide Corrective and Preventive actions. Includes the identification of issues, their investigation, and implementation of actions to address nonconformances and verification of the effectiveness of the actions.
Maintain the Global Nonconformance (NC) process to ensure compliance in areas of investigation, effectiveness, timeliness, quality and thoroughness of content.
Collaborate with process owners and stakeholders in Corporate, division and site to ensure the program is compliant, executable, and continuously improves.
Lead the reporting of quality system performance metrics to be used at all levels of the organization (site, division and corporate), collaborating with process owners and key stakeholders in corporate, division and site. Ensure NC and CAPA metrics are appropriately cascaded through Management Reviews.
Work closely with NC and CAPA owners to ensure timelines are met with high quality documentation. Standardize alert and action limits for escalations to senior leaders and other stakeholders
Ensure key process indicators of NCs and CAPAs are integrated into Quality Management Reviews.
Evaluate new regulations, guidelines and industry standards and their impact on CAPA and NC activities; plan and effectively implement plans across the business to maintain compliance.
All other duties and responsibilities as assigned