Supplier Quality Engineer

• Katalyst Healthcares & Life Sciences is hiring entry level candidates for several positions for contract research in Clinical trials of drugs, biologics and medical devices.
• We have a few immediate job opportunities available in Drug Safety and Pharmacovigilance and Clinical Research field. We work with University hospitals, pharmaceutical companies and recruiting partners.

 

Responsibilities:

• Select and evaluate suppliers by leading efforts to find new suppliers in an existing or new commodity.
• Conduct on-site supplier assessments as well as QMS audits and address the non-conformities.
• Work with suppliers and ISI engineering for the new product introduction to
• Complete part production qualification process ( PPQP), which includes but not limited to delivering on the following deliverables: spFMEA, Special Process Validations, Process capability, MSA, capacity analysis, and FAIR.
• Develop supplier ramp readiness based on forecast, supplier capacity, quality performance, and process capability.
• Perform DFM by engaging suppliers early in development cycle to feedback manufacturability improvements in the designs prior to production.
• Lead and resolve the supply continuity/ quality issues at suppliers through in depth root cause and corrective actions utilizing SCARs, SCRs (Supplier Change requests) processes.
• Monitor supplier performance and initiate improvement activities.
• Drive suppliers to continually improve their business and manufacturing process performance to meet Intuitive Surgical's requirements for supplier excellence including ship to stock programs using a collection of best practices in project management, Six Sigma, Lean, SPC and negotiation by leading these efforts without managerial guidance at several suppliers simultaneously.
• Develop and use metrics for supplier part cost, delivery, quality, capacity and capability by creating metrics to measure real improvement and judge required intervention or change at the supplier or in a commodity.
• Driving change to ISI specifications as necessary by understanding and changing specifications and drawings including driving the ECO process to implementation.
• Prepare and deliver supplier communications as required by independently working with suppliers on scorecard creation of QBRs, Supplier Summits, etc.
• Identify and investigate opportunities for cost reduction and/or quality improvement by judging opportunities and creating strategies to seize those opportunities, completes research and provides data-driven plans to management.

Requirements:

• BS degree in Engineering or equivalent, master's degree preferred.
• Excellent knowledge of 21 CFR part 820 and ISO 13485 (experience in auditing suppliers to these standards): Certified Lead auditor preferred but not required.
• Practical knowledge of PFMEA's and process validations.
• Ability to read and interpret detailed mechanical drawings and communicate technical information.
• Excellent problem solving and project management skills.
• Excellent written and verbal communication skills including presentations to executive level management.
• A proven history of implementing Lean/6 Sigma/SPC Programs at suppliers.
• Practical knowledge of part production qualification process.
• Significant computer experience using Windows, Word, Excel, Access and ERP Information Systems, preferably SAP.
• CAD experience with 3D modelling tools is a plus.
• Experience in a high-volume medical device company is a plus.
• Ability to travel to suppliers on an as needed basis – domestic and international.

All your information will be kept confidential according to EEO guidelines.