Supplier Quality Engineer

Katalyst Healthcares & Life Sciences; Sunnyvale (CA); On-site; USD 70,000 - 100,000; Full time

Job summary

Katalyst Healthcares & Life Sciences is seeking a Supplier Quality Engineer in Sunnyvale, California. This role involves evaluating and managing suppliers to ensure compliance with rigorous standards in medical device production.

The ideal candidate will have a BS degree in Engineering, with extensive project management and problem-solving skills. Strong knowledge of regulatory standards such as ISO 13485 is essential. The company offers opportunities for professional growth.

Qualifications

• BS degree in Engineering or equivalent, master's preferred.
• Excellent knowledge of 21 CFR part 820 and ISO 13485.
• Ability to communicate technical information effectively.

Responsibilities

• Evaluate suppliers and conduct on-site assessments.
• Lead supplier improvement initiatives and resolve quality issues.
• Develop and monitor supplier performance metrics.

Skills

Excellent problem solving skills

Project management

Excellent written and verbal communication

Practical knowledge of PFMEA's

Ability to read technical drawings

Experience in Lean/6 Sigma/SPC programs

Strong computer skills (Windows, Word, Excel, Access)

Education

BS degree in Engineering

Master's degree preferred

Tools

SAP

3D modelling tools

Job description

• 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.

Job Description

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.

Additional Information

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