Manufacturing Operations Quality Assurance Director - Salt Lake City
MedtronicAbout the role
At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You’ll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world.
A Day in the Life
Join us at Medtronic, where we are partnering across the industry to tackle systemic healthcare challenges with bold leadership. If you seek a challenging, energizing, and rewarding career that changes lives, we invite you to join our team. Become part of the next generation of life-changing medical technology, impacting patients worldwide.
At Medtronic, we must work with a sense of purpose and ownership, knowing that a human life lies on the other side of every decision.
At Medtronic, we bring bold ideas forward with speed and decisiveness to put patients first in everything we do. In-person exchanges are invaluable to our work. We’re working a minimum of 4 days a week onsite as part of our commitment to fostering a culture of professional growth and cross-functional collaboration as we work together to engineer the extraordinary.
As the Site Quality Leader/QA Director based in Salt Lake City, you will lead our quality site, quality system, and compliance, design assurance, quality operations, and CRB/CAPA board, specializing in the production of cutting-edge Neurovascular devices designed for stroke, aneurysm, and embolization treatments. Reporting to the Vice President of Quality for the Neurovascular Operating Unit, you will develop and implement quality management strategies that ensure the highest level of product quality and compliance. This includes harmonizing standards and processes, driving synergies, and fostering a culture of quality excellence. You will also partner with other Quality leaders to integrate Project Saint and its Quality function into Medtronic and Neurovascular Quality Systems.
Responsibilities may include the following and other duties may be assigned.
- Leadership & Quality Culture: Lead the manufacturing site towards excellence in product quality and operational excellence, fostering a culture that prioritizes quality and puts patients first. Champion continuous improvement and quality excellence, embedding quality in every aspect of operations.
- Talent Development: Develop and implement comprehensive training programs to enhance team skills and capabilities. Mentor and coach Managers and Engineers, providing opportunities for professional growth and career advancement.
- Inspection Readiness: Ensure manufacturing operations are inspection-ready every day by maintaining rigorous quality standards and documentation practices. Implement robust quality control processes and regular inspections to ensure compliance with regulatory requirements.
- Strategic Partnership: Collaborate cross-functionally with colleagues in Global Operations & Supply Chain, Strategy & Technology, Supplier Quality, Micro & Sterilization Assurance, Regulatory Affairs, R&D, and others to drive Quality and Enterprise Operations strategies.
- Quality Management: Oversee the development and maintenance of quality programs, systems, processes, and procedures that ensure compliance with policies and standards. Provide expertise in interpreting policies and regulations to ensure compliance.
- Manufacturing Quality Control: Oversee the quality and compliance of medical devices manufactured at the Site and ensure compliance with applicable quality system processes and regulations.
- Audit Leadership: Lead audit and inspection preparation, resolving findings, and liaising with auditing groups and inspectors. Facilitate uniform standards worldwide and enable the sharing of best practices.
- Continuous Improvement: Create a culture of continuous learning across areas of responsibility, identifying root causes of quality issues, and institutionalizing organizational learning.
Required Knowledge and Experience:
To be considered for this role, please ensure the minimum requirements and your permanent address are evident on your resume.
- Bachelor’s degree required.
- Minimum of 10 years of relevant Manufacturing Quality / Engineering experience with 7+ years of managerial experience, or an advanced degree with a minimum of 8 years of relevant Manufacturing Quality / Engineering experience with 7+ years of managerial experience.
Nice to Have
- Experience in the Medical, Pharmaceutical, or highly regulated product industry.
- DMAIC Lean / Six Sigma Certification and demonstrated experience leading DMAIC Projects. <
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