PDS Tech, Inc. is seeking an Engineering Expert in Pittsburgh, PA.
This Supplier Quality Engineer is directly responsible for the quality of supplied material. This position must evaluate the technical capabilities of suppliers while working in partnership with internal customers to assure a continued supply of qualified parts to manufacturing. This position will be responsible for working with various suppliers to ensure all quality controls are in place and all regulatory requirements are met. Material Qualification Agreements and First Article Inspection reports will need to be established to confirm conformance to the specification. This position will also require the Supplier Quality Engineer to issue corrective actions (SCARS) to Suppliers and work with Suppliers to help improve operations quality controls to ensure uninterrupted supply of quality materials.
Position Duties and Responsibilities
• Ability to manage projects related to supplier quality and Supplier relationships to optimize performance at Supplier locations, Supply Centers and other operational affiliates.
• Responsible for Supplier Quality deliverables in NPD and LCE environments.
• Demonstrates understanding of Medical Device operations, V&V, ISO standards and quality and regulatory requirements and fundamental knowledge of various manufacturing processes such as injecting molding, casting and electronic assemblies.
• Forms partnerships with Suppliers and Supply Center leadership to drive accountability in manufacturing processes, externally and internally.
• Identifies supplier-related problems & opportunities. Performs root-cause analysis and drives resolution.
• Leads and monitors process validations (IQ, OQ, PQ).
• Comfortable with Failure Analysis Methodologies to drive Supplier Corrective actions.
• Manages own work activities to given objectives with supervision
• Achieve an understanding of the products and their applications.
• Effectively convey problems, opportunities and results.
• Possess an understanding of ISO standards, FDA regulations and the Medical Device Directive (MDD)
• Education Minimum Requirement Bachelors Degree
Skills & Competency Requirements
• 0-5 years experience, including working knowledge and application of engineering and scientific concepts in a selected technical discipline
• Basic knowledge of other technical disciplines
• ISO 9001 and/or ISO 13485 knowledge
• Working knowledge and proven skills of PC computer operating systems including MS Office applications as well as Quick Base.
• Understanding of basic statistics. Ability to review and understand statistical data through Minitab.
• Certified Quality Engineer/Certified Quality Auditor certificate is not required but preferred
• Ability to travel domestically? 5% of the time