About the position
Imagine how your ideas and expertise can change a patient's life. Our Quality teams help shape the development of groundbreaking technologies to ensure each stage of our innovation process is held to the highest standards of integrity and safety. You'll bring your passion for problem solving and partner with various teams to influence decision-making for a product's entire lifecycle. Your work will involve you optimizing product development to impact patients around the world with pioneering technology. The Manager, Supplier Quality Engineering will manage a team of engineers and techs to provide direction and oversight of supplier quality activities and play a key role leading critical projects that support our COE (Center of Excellence) for Metals and Advanced Catheter Delivery System. This position is cross-functional in nature and requires strong collaboration and partnership with R&D, Design Assurance, Operations, Regulatory Affairs, Marketing, Sourcing, Supplier Development Engineering and Receiving Inspection. This manager will not only manage stakeholder relationships but also lead successful part qualification efforts with external suppliers to support product development and commercial launch timelines for innovative and life-saving medical devices. The manager will work on-site in a very fast-paced and dynamic environment where being proactive and taking initiative are paramount to success.
Responsibilities
- Lead complex, medium-scale projects with significant business impact, ensuring successful delivery of all milestones.
- Develop and manage project plans, schedules, and quality objectives while applying engineering expertise to evaluate and improve supplier designs and processes for new to market devices and novel technologies.
- Lead root cause investigations of complex product quality and compliance issues related to supplier manufacturing processes.
- Lead the development and execution of complex experiments and test methods to validate and improve products and manufacturing processes/methods.
- Ensure the optimization of complex internal and supplier manufacturing processes using engineering methods for design for manufacturing and for continuous process improvement.
- Ensure validation methods of critical suppliers and incoming quality control are aligned with international standards, global regulations, and industry best practices.
- Develop technical content of risk management files.
- Develop training and documentation materials on component test methods for Receiving Inspection.
- Conduct on-site supplier audits.
- Manage a team of supplier quality engineers, while driving talent development aligned with departmental growth strategies.
Requirements
- Bachelor's degree with 6 years of experience in either Supplier Quality, Manufacturing, New Product Development/Improvement, or Quality Engineering functions; OR a Master's degree with 5 years of experience in either Supplier Quality, Manufacturing, New Product Development/Improvement, or Quality Engineering functions.
- Well-versed in statistical tools such as Gage R&R, Statistical Process Control, Process Capability Studies, Hypothesis Testing, and other statistical techniques related to manufacturing.
- Project Management Experience.
- Demonstrated leadership capabilities in coaching/guiding less seasoned engineers and teammates.
- Highly regulated industry experience.
Nice-to-haves
- Engineering degree.
- Experience with supplier/vendor management and qualification activities with new suppliers, CMOs, or OEMs for new products.
- Experience with CAPAs, NCRs, Change Notifications, and/or Auditing.
- Demonstrated experience driving component testing, test method validations, and testing/validating equipment.
- Experience creating inspection routines on optical measurement equipment and design and creation of inspection fixtures using SolidWorks.
- In-depth understanding and experience with risk management for validation qualifications.
- In-depth knowledge of manufacturing process for shaft manufacturing, injection molding and extrusions.
- Knowledge and understanding of FDA and international regulatory standards for medical devices.
- Six Sigma Green or Black Belt Certified.
