Supplier Quality Engineer, Senior

Forj Medical; Saint Paul (MN); On-site; USD 100,000 - 130,000; Full time

Job summary

Forj Medical is seeking a Senior Supplier Quality Engineer to oversee our supplier quality base for complex electronic and software medical devices. You will provide technical leadership, drive design and process improvements, and manage supplier selection, audits, and issue resolution.

The role demands 6+ years in supplier quality plus 3+ years in FDA-regulated medical devices, with PCB/PCBA experience and strong problem-solving abilities. Travel ~10% possible.

Qualifications

• Bachelor's degree in engineering required.
• 6+ years in supplier quality, component engineering, or supplier support.
• 3+ years in FDA-regulated medical devices.
• Experience with PCB assemblies and PCBs.
• Experience with process qualification and validation for medical devices.
• Experience with lean manufacturing and problem solving.
• Ability to communicate technical issues across functions.
• Lead auditor training/certification (ISO 13485 and/or FDA QSR) preferred.

Responsibilities

• Lead issue investigations and resolutions with direct material suppliers.
• Oversee supplier qualification, audits, and problem resolution.
• Support supplier management to ensure materials meet specs.
• Support quality system audits and supplier-related CAPA and SCAR activities.
• Collaborate with strategic suppliers to improve cost of quality and lead times.

Skills

Root cause analysis

Technical communication

Lean manufacturing

FDA regulated devices

Process risk management

Education

Bachelor's degree in engineering

Tools

ERP/MRP systems

Job description

Exceptional People. Hard Problems. Meaningful Careers. Big Impact.

Nowhere else can you touch as many life-changing medical technologies. At Forj Medical, we work side by side with more than 100 medical device companies from startups to global giants to bring life-enhancing technologies to market. Working with us means solving hard problems with extraordinary people in a collaborative work environment. Join us.

Job Summary

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.

Essential Duties And 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.
• Travel approximately 10%

Required Qualifications

• 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)

Preferred Qualifications

• 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.

Compensation

• The expected starting salary for this position is $100,000 to $130,000 depending on qualifications. As part of your overall rewards, we offer a comprehensive benefits program.

EEO Statement

Forj Medical provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training.

Employment Requirement

Must be authorized to work in the United States.

Compensation And Total Rewards Package

The salary range for this position is outlined below under "Job Details" and is dependent upon the individual's skills, experience, qualifications, and applicable employment laws. Beyond base salary, Forj offers a competitive Total Rewards Package. We offer health, dental, vision, 401K plans, and time off programs. You may also be eligible to participate in an annual bonus program which depends on various factors, including, individual and organizational performance.