Position: Supplier Quality Engineer

Location: Zelienople, PA

Duration: 12+ Months Contract

Total Hours/week: 40.00

1st Shift

Client: Medical Device Company

Employment Type: Contract on W2 (Need US Citizens Or GC Holders Only)

No H1B’s

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

Job Details:

• Lead production part approval process (PPAP) activities with the supplier, including but not limited to, first article inspection, process qualification, control plans, PFMEA, etc.
• Actively participates in activities for supplier qualification, including supplier audits
• Tracks supplier quality trends and initiates supplier corrective actions to resolve issues
• Manages assigned corrective actions and drives them to closure
• Trends, analyzes, and reports on quality data to improve products and processes

Candidate Qualifications:

• BS in Electronics/Electrical Engineering, Mechanical Engineering, Bio-Medical Engineering, or equivalent required
• 1-3 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
• Demonstrated strong attention to detail and “do it right the first time” attitude required
• Flexible, with ability to work effectively in a fast-paced, dynamic environment with shifting and competing demands is required
• ASQ Certified Supplier Quality Engineer, ASQ Certified Quality Auditor certification (or equivalent) or ability to obtain it is required
• Basic knowledge of electro-mechanical devices preferred
• Familiarity with ISO14971 and associated Risk Management Processes preferred
• 2+ years of auditing experience preferred