Lead supplier quality engineering activities for regulated medical device products, including supplier qualification, change management, audits, quality agreements, CAPA, NCMR, SCARs, risk management, and performance analysis. Partner with suppliers, Procurement, R&D, and Operations to resolve quality issues, prevent disruptions, and improve processes. Ensure compliance with ISO 13485, FDA regulations, ISO 14971, and good manufacturing practices while independently driving supplier quality projects.
Title: Staff Supplier Quality Engineer
This position is based in our Campbell, California offices. This position is on-site, full-time.
Why Imperative Care?
Do you want to make a real impact on patients?
As part of our team at Imperative Care, you can help elevate care for patients suffering from stroke and other devastating vascular diseases. Every day, the technologies that we develop at Imperative Care directly impact people at the most vulnerable moments of their lives. Our focus is on the needs of the patient, and they come first in everything we do.
What You’ll Do
Provide Supplier Quality Engineering support in the development, manufacture, and distribution of Imperative Care’s medical device products consistent with the Company’s Quality Policy and Quality Objectives. Establish and maintain quality assurance standards that adhere to ISO 13485, FDA and other governmental regulations.
- 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 supplier’s 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
What You’ll Bring:
- 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 industry Lead 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
Employee Benefits include a stake in our collective success with stock options, competitive salaries, a 401k plan, health benefits, generous PTO, and a parental leave program.
Join Us! Imperative Care
Salary Range: $150,000 – 167,000
Please note that the salary information is a general guideline only. Imperative Care considers factors such as scope and responsibilities of the position, candidate's work experience, education/training, key skills, and internal equity, as well as location, market and business considerations when extending an offer. As part of our total rewards package, Imperative Care offers comprehensive benefits including a 401k plan, health benefits, generous PTO, a parental leave program and emotional health resources.
Imperative Care Campbell, California, USA Office
Dell Ave, Campbell, CA, United States, 95008
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