Staff Supplier Quality Engineer

• Collaborate with suppliers and business partners to ensure robust materials products processes and systems.
• Implement supplier change management process including change notification dissemination of information impact assessment approval of changes and supports material/supplier qualifications.
• Lead component qualification change projects in collaboration with key business partners and the suppliers applicable functional groups.
• Manage and raise supplier issues when intervention or a change at a supplier.
• Monitor and analyze supplier performance metrics identify areas of opportunity communicate supplier risks and drive the resolution of supplier quality issues and risk control processes.
• Support internal and supplier related NCMR and CAPA. Drive corrective actions for supplier process by assisting suppliers to true root cause analysis and CAPA
• Plan conduct report and follow-up on supplier quality system audits
• Drive and execute supplier quality agreements
• Partner with Procurement R&D Operations and Suppliers in the timely investigation resolution/prevention of supplier-related issues to minimize/prevent business disruptions.
• Own drive and lead the assigned Supplier Quality related projects activities initiatives with limited supervision.
• Apply Project Management methodologies to plan organize connect shape lead and deliver results for supplier quality management (SQM) projects.
• Apply analytical and problem-solving skills to develop and optimize supplier performance.
• Analyze quality data and identify trends impacting risk benefits requirements of product and quality systems for external suppliers. Lead discussions to drive resolution.
• Develop/implement Quality Risk Management process for supplier-related matters with partnerships of subject-matter-experts (SME)
• Responsible for presenting supplier-related issues or opportunities to next management level

• BS in Engineering or related discipline and 8 years of supplier quality experience; or MS in Engineering with 6 years of related experience; or equivalent combination of education and work experience in the medical device or related regulated industryLead development and validation of test methods to comply with recognized standards
• Must have experience with catheters endovascular or neurological devices
• Must have demonstrated ability to perform multiple tasks concurrently with accuracy
• Experience leading supplier or process issues (CAPAs NCMR/NCRs SCARs etc.)
• Must have strong knowledge of quality system requirements (FDA 21 CFR Part 820 ISO 13485) risk management standards (ISO 14971) and good manufacturing practices
• Excellent communications skills (both written and verbal)
• Must be able to provide thorough and meticulous review of documents
• Must be able to write clear concise and well thought out technical documentation.
• Proficiency with Microsoft Office products
• Ability to communicate effectively both orally and in writing with all organizational levels
• Strong attention to detail and ability to function in a fast-paced dynamic environment

The use of external recruiters/staffing agencies requires prior approval from our Human Resources Department. The Human Resources Department at Imperative Care requests that external recruiters/staffing agencies not to contact Imperative Care employees directly in an attempt to present candidates. Complying with this request will be a factor in determining future professional relationships with Imperative Care.

Imperative Care will not accept unsolicited resumes from any source other than candidates themselves for either current or future positions. Submission of unsolicited resumes in advance of an agreement between the Human Resources Department and the external recruiter/staffing agency does not create any implied obligation on the part of Imperative Care.