Staff Supplier Quality Engineer

Imperative Care; Kentucky; On-site; USD 150,000 - 167,000; Full time

Benefits offered by this job

Stock options

401k plan

Health benefits

Generous PTO

Parental leave program

Job summary

Imperative Care seeks a Staff Supplier Quality Engineer to join our on-site team in Campbell, CA. You will provide supplier quality engineering support for medical devices, ensuring compliance with ISO 13485 and FDA requirements.

The role involves leading supplier change management, CAPA, NCMR, audits, and cross-functional collaboration. The ideal candidate has a strong background in supplier quality within regulated medical devices, experience with catheters or neurovascular products, and

Qualifications

• B.S. in Engineering or related discipline with 8+ years of supplier quality experience; or M.S. in Engineering with 6+ years of related experience.
• Experience with FDA 21 CFR Part 820, ISO 13485, ISO 14971 and GMP practices.
• Experience with catheters, endovascular or neurological devices.

Responsibilities

• Provide SQE support in development, manufacture and distribution of medical devices.
• Establish and maintain quality assurance standards per ISO 13485 and FDA regulations.
• Lead supplier change management, CAPA, NCMR, and supplier audits.
• Drive supplier quality improvements and risk management with cross-functional teams.
• Collaborate with Procurement, R&D, Operations to resolve supplier-related issues.

Skills

Supplier quality management

Multitasking

Analytical problem solving

Documentation review

Effective communication

Education

B.S. in Engineering

M.S. in Engineering (optional)

Tools

Microsoft Office

Job description

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 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

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.

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.

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.