Supplier Quality Engineer 2-3-4
United States - WA - Snoqualmie
At Spacelabs Healthcare, we are on a mission to provide continuous innovation in healthcare technology for better clinical and economic outcomes. Our scalable solutions deliver critical patient data across local and remote systems, enable better-informed decisions, increase efficiencies, and create a safer environment for patients.
Why work at Spacelabs? Because lives depend on you!
The Supplier Quality Engineer (SQE) will provide leadership and guidance to cross-functional, multilevel technical teams to assure causes of product quality issues and non-conformances are identified and understood, and that sound corrective and preventive actions are implemented. This position supports supplier selection and approved supplier list (ASL) qualification. This individual will manage and document supplier corrective actions for systemic product quality and process issues identified through trending and quality system audits. The SQE is responsible for conducting audits per annual supplier schedule and driving investigation and corrective actions to closure. The SQE will ensure quality standards are in place and followed, develop and implement inspection strategies, and report on the current state of supplier’s performance, and keep management informed on a regular basis to ensure corrective/preventive action is taken where necessary.
- Implement and execute quality plans to monitor and improve the supply chain, ensuring quality components that meet specifications. Establish all QMS and regulatory requirements with assigned suppliers and ensure they are met.
- Develop and implement part and process qualification requirements to ensure that delivered products meet specification and quality/reliability requirements. Ensure that verification processes are trained, implemented, measured and effective.
- Develop annual supplier audit schedule
- Perform or manage on-site supplier audits.
- Develop and maintain metrics to trend and report critical supply chain quality issues, and use them to launch timely response. Provide frequent communications and formal status reviews with senior management, QA team and others as required.
- Recommend and implement supplier improvement plans. Develop requirements, specifications, schedules, risk analysis, and tradeoff analysis.
- Manage supplier corrective action requests to closure, and train internal team members on SCAR requirements.
- Support development of incoming product strategy, First Article Inspections, and investigation and disposition of nonconforming materials.
- Ensure contract resources are effectively managed and deliver services and products as promised, and that meet our QMS requirements.
- Uphold the Company’s core values of Integrity, Innovation, Accountability, and Teamwork.
- Demonstrate behavior consistent with the Company’s Code of Ethics and Conduct.
- It is the responsibility of every Spacelabs Healthcare employee to report to their manager or a member of senior management any quality problems or defects in order for corrective action to be implemented and to avoid recurrence of the problem.
- Duties may be modified or assigned at any time to meet the needs of the business.
- Bachelor’s Degree in engineering or technical discipline (or non-technical degree with 4 years of experience)
- 3+ years (for level 2) (5+ years for level 3, 8+ years for level 4)) of Quality Assurance experience in a regulated manufacturing environment, with at least 1 year (for level 2) (2 years for level 3, 3+ years for level 4) in medical device manufacturing. Overall relevant experience determines level.
- Experience with supplier corrective actions
- Auditing experience
- Experience with one or more of the following:
- Quality Management System electronic tools and continuous improvement methodologies
- FDA, ISO or EU Medical Device Directive (MDD)
- Manufacturing standards, such as SPI Cosmetic Specifications of Injection Molded Parts and IPC-A-610 Acceptability of Electronic Assemblies
- Interpreting Engineering Drawings
- ANSI/ASQZ1.4-2008 Sampling Procedures and Tables for Inspection by Attributes.
- Ability to manage multiple, complex priorities within demanding timeframes. Strong project management skills.
- Highly developed relationship-building skills, and strong presentation and communication skills.
- Experience working positively and productively in a team environment. Highly collaborative.
- Proven ability to deliver results through others, both direct and matrixed. Proven ability to lead, develop, motivate and hold others accountable.
- Experienced user in PowerPoint, Excel, and Word required.
- Must travel (domestic and international) and be able to acquire all necessary travel documents.
- Must be able to complete job responsibilities working with global time zone needs such as attending late night/early morning meetings by phone and/or web to meet global business needs.
- Certified Quality Auditor (ISO 13485 lead auditor) or similar certification
Equal Opportunity Employer
EEO is the Law
OSI Systems, Inc. has three operating divisions: (a) Security, providing security and inspection systems, turnkey security screening solutions and related services; (b) Healthcare, providing patient monitoring, diagnostic cardiology and anesthesia systems; and (c) Optoelectronics and Manufacturing, providing specialized electronic components and electronic manufacturing services for the Security and Healthcare divisions, as well as to external original equipment manufacturer clients for application in the defense, aerospace, medical and industrial markets, among others.