Advantage Resourcing has an opening for a Supplier QA Engineer for our client in Sunnyvale, CA.
Responsible for ensuring suppliers meet requirements for cost, quality, delivery and service.
Drive suppliers to continuously improve business and manufacturing processes.
Evaluate and select suppliers.
Guide Engineering in choosing suppliers for new products and provide DFM input to new designs.
Monitor supplier performance.
Roles and 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 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.
Educational/Job Skill Requirements:
• BS degree in Engineering or equivalent, Masters 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 pfmeas 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 modeling 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 (within North America for the most part)
About Advantage Resourcing
Advantage Resourcing is committed to providing equal employment opportunity for all persons regardless of race, color, religion (including religious dress and grooming practices), sex, sexual orientation, gender, gender identity, gender expression, age, marital status, national origin, ancestry, citizenship status, pregnancy, medical condition, genetic information, mental and physical disability, political affiliation, union membership, status as a parent, military or veteran status or other non-merit based factors. We will provide reasonable accommodations throughout the application, interviewing and employment process. If you require a reasonable accommodation, contact us. Advantage Resourcing is an E-Verify employer. This policy is applicable to all phases of the employment relationship, including hiring, transfers, promotions, training, terminations, working conditions, compensation, benefits, and other terms and conditions of employment.
All employees are directed to familiarize themselves with this policy and to act in accordance with it. All decisions with respect to employment matters and other phases of employer-temporary employee relationships will be in keeping with this policy and in accordance with all applicable laws and regulations.
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