Supplier Quality Engineer

Job Summary

The Supplier Quality Engineer is accountable for supplier/vendor selection, qualification, and approval, as well as supplier process qualifications, monitoring suppliers, and supplier corrective action requests. This position involves direct interaction with the Procurement, Division R&D, Manufacturing, Service, and Manufacturing Engineering groups to support new product introduction, continuous improvement, and manufacturing sustaining activities. The role requires exceptional communication, interpersonal, and project management skills to effectively coordinate activities and deliver results. An understanding of quality standards and regulations (21CFR 820, ISO-13485) is necessary.

Job Details

• Provides focused supplier quality engineering support and assumes responsibility for timely and effective coordination and/or execution of assigned project activities
• Acts as an effective team member in supporting quality discipline, decisions, and practices
• Applies sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving supplier quality issues
• Trends, analyzes, and reports on quality data to improve products and processes

Candidate Qualifications

• BS in Electronics, Electrical, Mechanical, Bio-Medical, etc. required
• 2+ years’ experience in Medical Device manufacturing or similarly regulated industry required
• Proven ability to develop and/or approve supplier PFMEAs, Control Plans, Measurement System Analysis, Special Process Validation, FAI, Routine Lot Acceptance activities is required.
• Experience with MS Office Products (Word, Excel, Visio, Project, PowerPoint, Outlook, etc.) required
• Excellent oral and written communication skills with the ability to communicate with audiences of varying technical skills required
• Ability to understand, plan, and execute supplier qualification activities required
• Demonstrated strong attention to detail and “do it right the first time” attitude required
• Good judgment and decision-making skills are required; knows how to make trade-off decisions while balancing compliance and business impact required
• Flexible, with ability to work effectively in a fast-paced, dynamic environment with shifting and competing demands is required
• Ability to travel up to 30% is required
• Basic knowledge of electro-mechanical devices preferred
• ASQ Certified Supplier Quality Engineer, ASQ Certified Quality Auditor, or equivalent preferred
• Familiarity with ISO14971 and associated Risk Management Processes preferred
• Three to five years of experience in a medical device quality assurance environment preferred
• One to two years of auditing experience preferred