Supplier Qual Engineer II at Medtronic in North Haven, Connecticut

Job Description:

Careers that Change Lives

Surgical Robotics

The Surgical Robotics business strives to enable earlier diagnosis, better treatment, faster complication-free recovery, and enhanced patient outcomes through the use of a minimally invasive surgical robotic solution.

The Senior Supplier Quality Specialist is responsible for managing finished goods Contract Manufactured (CM) for Surgical Robotics. Primary duties are focused on all QMS related matters pertaining to selection, qualification, manufacturing, QMS development, and technical quality/service/costs improvements.

Responsibilities may include the following and other duties may be assigned.

• Ensures that suppliers deliver quality parts, materials, and services.
• Qualifies suppliers according to company standards and may administer a Certified Supplier Program in receiving inspection to ensure cost effectiveness.
• Monitors parts from acquisition through the manufacturing cycle and communicates and resolves supplier-related problems as they occur.
• Develops and prioritizes an auditing schedule to ensure that designated suppliers are audited on a regular basis to ensure good manufacturing practices (GMP) and quality standards are met.
• Evaluates suppliers' internal functions to assess their overall performance and provides feedback in assessment of their operation.
• Support, review and approval of Validation, MSA, Control Plan, PPAP, etc. deliverables from suppliers related to product introduction or transfers.
• Manage supplier monitoring and performance including non-conformances, CAPA, SCAPA, and complaints.
• Support the Quality Engineering team to improve and maintain an effective and efficient Supplier Quality process to support the finished goods product.
• Qualifying production components through Medtronic's PPAP.
• Evaluation of component and sub-assembly subcontractors to ensure device quality and conformance to standards and regulations.
• Support CM led Process FMEAs (pFMEAs) in a manufacturing environment for subsystems within the Minimally Invasive Surgical System.
• Participating in CM Defect / Issue Management and Change Control Boards, as appropriate.
• Manage communication of CM and sub-supplier deviation requests pre-process validation activities.
• Ensure proper approval, documentation and communication practices are followed for any Supplier Change Request at CMs.
• Developing Quality inspection procedures, including sampling plans, for both production level components and finished devices.
• Initiating corrective action requests on non-conformances (internal or external) and verifying the effectiveness of corrective actions.
• Ensure the development of and compliance to Process Flows, Control Plans, Measurement Systems Analyses, Process monitoring, and Validation processes.
• Interact and form constructive working relationships with all levels of leadership within the Contract Manufacturer's Quality, Procurement, Marketing, R&D, and Operations.

Must Have: Minimum Requirements

• Bachelor's Degree in Engineering, Science or technical field with 2+ years of work experience in Engineering and/or Quality
• OR Advanced Degree in Engineering, Science or technical field with 0+ years of work experience in Engineering and/or Quality

• Expertise in Production Part Approval Process (PPAP)
• Expertise in Process Validation and ongoing manufacturing activities of a commercialized medical device.
• ASQ Certified Quality Engineering (CQE), Certified Quality Auditor (CQA)
• Six Sigma Green belt or Black Belt certified
• Geometric Dimension and Tolerance activities.
• Knowledge and experience in developing and manufacturing medical devices in conformance with Quality System Regulations, ISO9001, 13485, and 14971 requirements.
• Experience with analytical tools and methods, including statistics (Minitab preferred), DOE, and the use of iccarcomputer software packages related to design, development and manufacturing

About Medtronic

Together, we can change healthcare worldwide. At Medtronic, we push the limits of what technology, therapies and services can do to help alleviate pain, restore health and extend life. We challenge ourselves and each other to make tomorrow better than yesterday. It is what makes this an exciting and rewarding place to be.

We want to accelerate and advance our ability to create meaningful innovations - but we will only succeed with the right people on our team. Let's work together to address universal healthcare needs and improve patients' lives. Help us shape the future.

Physical Job Requirements

The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. For Office Roles: While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer, and communicate with peers and co-workers. Contact your manager or local HR to understand the Work Conditions and Physical requirements that may be specific to each role. (ADA-United States of America)

Additional Information

• Posting Date: Nov 19, 2020
• Travel: Yes, < 25 % of the Time