Director, Quality Programs-Integrated Supply Chain; ISC)

Director, Quality Programs-Integrated Supply Chain (ISC) page is loaded## Director, Quality Programs-Integrated Supply Chain (ISC) locations:
Plymouth, Minnesota, United States:
Cambridge (US), Massachusetts, United Statestime type:
Full time posted on:
Posted Todayjob requisition ### Job Title Director, Quality Programs-Integrated Supply Chain (ISC)###

Job Description The
** Director, Quality Programs-Integrated Supply Chain (ISC)
** provides strategic leadership for enterprise and site-level quality programs within FDA regulated medical-device manufacturing environments. This role will lead large scale, global, cross-functional programs that strengthen the quality management system, improve compliance, reduce risk, and advance operational excellence.
** Your role:
**** Leadership and Team Management:
*** Lead, mentor, and manage a team of Program Managers and data analyst responsible for quality programs.
* Foster a collaborative and high-performance culture within the team.
* Provide guidance, support, and development opportunities to ensure team effectiveness and professional growth.
** Strategic Planning and Execution:
*** Develop and implement strategic plans for quality programs, including Artificial Intelligence (AI), that align with organizational goals and regulatory requirements.
* Oversee the planning, execution, and completion of quality compliance projects to ensure they lead them in accordance with timelines, budgets, and objectives.
* Identify and address potential risks and issues that could impact project success.
** Product Quality, Quality Management System, Compliance and Standards:
*** Ensure adherence to industry standards, regulatory requirements, and internal quality policies.
* Monitor and evaluate the effectiveness of quality programs, making adjustments as needed to maintain compliance and improve outcomes.
* Stay informed about industry trends and best practices to continuously enhance quality programs.
* Lead improvements in data and analytics by improvement current tools and practices
*
* Cross-Functional Collaboration:

*** Collaborate with other departments, including Operations Quality, Operations, Engineering, Business, and Supply Chain, on programs and outcomes.
* Serve as the primary point of contact for quality-related inquiries and concerns from internal stakeholders.
** Reporting and Documentation:
*** Prepare and present reports on project status, performance metrics, and compliance to senior management.
* Ensure accurate and timely documentation of quality program activities, including project plans, reports, and compliance records.
** Continuous Improvement:
*** Drive a culture of continuous improvement by implementing best practices and innovative solutions to enhance quality and efficiency.
* Lead initiatives to identify opportunities for process improvements and implement corrective actions as needed
** You're the right fit if:
*** You have a minimum of 10+ years' experience in FDA regulated medical device manufacturing/supply chain environments, providing strategic leadership for large scale, global, cross-functional quality programs/projects.
* You have a proven track record of successful program/project management, transformation, change management, continuous improvement and team leadership in a matrix environment
* You have proven experience in functional management of PMO/Quality teams, including budgeting, workforce planning, Performance Management, Employee Engagement/ Retention, Succession Planning, coaching, training, etc.
* You have strong understanding of Medical Device regulations/standards including ISO 13485/14971, 21

CFR (803, 806, 820, etc.), MDD/ EU MDR, GMP, and GDP.
* You have proven expertise utilizing/improving data analytics
- Quality KPI's/Data Analysis to assess program/quality/team performance and identify process and continuous improvement opportunities.
* You're able to effectively communicate, influence and build relationships with cross-functional team members at ALL levels.
* You have a minimum of a Bachelor's degree in Quality, Engineering or a related Scientific discipline (required). Advanced degree or relevant certifications (e.g., Six Sigma, PMP) preferred.
* You must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this .
** How we work together:
** We believe that we are better together than a part. For our
*** Office-based
*** teams, this means working in-person at least 3 days…