Supplier Quality Engineer, Senior

Forj Medical•Saint Paul, MN

3d•$100,000 - $130,000•Onsite

About The Position

The Senior Supplier Quality Engineer (SQE) will oversee the quality of the Forj Medical supply base in order to ensure Forj Medical suppliers provide defect-free materials and services for complex electronic and software based medical devices. The SQE will provide technical leadership to drive continuous design and process improvements to meet quality, performance, and schedule goals. As a member of the SQE team duties include the selection and development of suppliers as well as; conducting site audits, perform source inspection, process reviews, address and resolve supplier quality related issues.

Requirements

Bachelor’s degree in engineering discipline
Minimum 6 years’ experience to include:
Minimum 4 years supplier quality, component engineering, and/or supplier engineering support experience.
Minimum 3 years’ experience in FDA regulated medical device industry.
Demonstrated experience in processes, equipment, and control methodologies for Printed Circuit Board Assemblies (PCBA) and Printed Circuit Boards
Demonstrated experience in process qualification and validation for medical devices.
Demonstrated experience in materials qualification and validation.
Demonstrated experience in lean manufacturing practices and team facilitation.
Demonstrated experience in problem solving and root cause analysis methods.
Demonstrated experience in process risk management methods.
High proficiency in use of standard electronic business tools: Outlook, Word, PowerPoint, Excel and ERP/MRP systems.
Experience in use of statistical analysis software.
Effective communication skills of technical issues to various functional levels, ability to make data driven decisions, passionate for change and continuous improvement, and embodying a strong sense of urgency.
Lead Quality Auditor training/certification (ISO 13485 and/or FDA QSR)

Nice To Haves

Experience in processes, equipment, and control methodologies for the following commodity industries: Stamping and Machining, Injection Molding, Displays and Overlays
Experience in developing control plans during design transfer phases of projects.
Experience in partnering with Sourcing and Materials professionals
Experience Lean Six Sigma certified Green/Black belt
Experience in Electronics Manufacturing Services (EMS) business
Experience in poka-yoke strategies
Demonstrated leadership behaviors including effective communication at various functional levels, critical thinking and decision making, change agent, and embodying a strong sense of urgency.

Responsibilities

Lead issue investigation and issue resolution with direct material suppliers.
Lead the activities and manage the effectiveness of business processes (i.e. NMR, Complaint Investigations, CAPA, SCARS, Process Qualification & Validation, Process Control & Monitoring, Engineering Change Control, etc…) directly supporting the production business.
Support the supplier management process including selection, approval/qualification and problem resolution to ensure materials delivered meet specifications.
Support the Quality System audit program, including leading audits as required.
Partner with strategic suppliers to develop capabilities and controls necessary to improve cost of quality, reduce production down time, and build predictability in material lead times.
Support change efforts and continuous improvement initiatives inside the company associated with Supplier Quality Engineering processes
Develop and mature procedures and associated processes for Supplier Quality Engineering
Defines/support quality performance metrics for key processes/commodities and takes appropriate action based upon resulting performance.