Top 177273 Supplier quality development engineer Jobs

Supplier Quality Engineer
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- Full-time
- Hybrid work
- Background check
- 5 years
- Mid-level
- Health insurance
- Dental insurance
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Bradbury Stamm Construction Inc. —Albuquerque, NM
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Inland Empire Health Plan —Rancho Cucamonga, CA
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Trelleborg Sealing Solutions US, Inc —Litchfield, MN
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Supplier Quality Engineer

Sonablate Corp.
Indianapolis, IN

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Job Details

Full-time
$100,000 - $115,000 a year
9 days ago

Benefits

Health insurance
Dental insurance
401(k)
Paid time off
Vision insurance

Qualifications

Six Sigma Green Belt
Bachelor's degree
Problem-solving
Contracts
PPAP

Full Job Description

Company Overview

Sonablate Corp. is a global leader in minimally invasive, high-intensity focused ultrasound (HIFU) technologies dedicated to advancing precise and innovative medical procedures. With a commitment to quality and regulatory excellence, Sonablate designs, manufactures, and services cutting-edge medical devices that support a broad range of therapeutic applications worldwide.

About the Role

Sonablate Corp. is seeking a Supplier Quality Engineer to support supplier qualification, supplier development, supplier quality performance, and regulatory compliance within a medical device manufacturing environment.

This role will work closely with Quality, Regulatory, Engineering, Materials, and external suppliers to ensure purchased components, materials, and services meet Sonablate’s quality, regulatory, and business requirements. The Supplier Quality Engineer will support supplier selection, supplier audits, corrective action activities, first article inspection, quality agreements, raw material specifications, and continuous improvement initiatives.

The ideal candidate will have strong supplier quality experience in a regulated manufacturing environment, preferably medical devices, and will be comfortable working directly with suppliers to resolve quality issues and improve performance.

Key Responsibilities

Conduct supplier validation audits and support supplier qualification activities.
Assist Engineering in the supplier approval process by assessing supplier manufacturing and technical capabilities.
Support new product launches by ensuring supplier quality requirements are defined, communicated, and achieved.
Facilitate root cause analysis and corrective action activities related to supplier quality issues.
Perform supplier visits as needed to support investigations, corrective actions, and verification of effectiveness.
Work directly with suppliers to develop and implement corrective action plans.
Monitor and support supplier performance related to quality, cost, delivery, and continuous improvement.
Conduct supplier audits to evaluate material controls, process controls, and compliance with applicable requirements.
Work with Materials and Engineering to support supply chain structure throughout the product lifecycle.
Support Design for Manufacture and Assembly activities between Sonablate and suppliers.
Manage supplier-related nonconformances, containment activities, investigations, and problem resolution.
Document and communicate findings related to quality system improvement and regulatory compliance.
Oversee first article inspection activities and work with suppliers to resolve raw material or manufacturing process failures.
Support the creation and maintenance of supplier quality agreements, contracts, and raw material specification agreements.
Generate and maintain quality system documentation.
Lead or support quality investigations and quality improvement efforts.
Identify best practices and incorporate them into existing supplier quality processes.
Support compliance with applicable quality system regulations, certified standards, and customer requirements.
Manage multiple projects and priorities while meeting deadlines.
Partner cross-functionally with internal teams to resolve supplier and quality issues.
Perform other duties as assigned.

Qualifications

Bachelor’s degree in a technical field preferred; equivalent work experience may be considered.
Minimum of 5 years of related Quality Assurance or Supplier Quality experience in a regulated manufacturing environment.
Medical device manufacturing experience strongly preferred.
Strong knowledge of medical device quality system requirements.
Experience with supplier audits, supplier qualification, supplier corrective actions, and supplier performance management.
Working knowledge of APQP, PPAP, FMEA, root cause analysis, CAPA, and nonconformance management.
Working knowledge of data analysis techniques such as Gage R&R, ANOVA, DOE, SPC, probability, and process capability preferred.
ASQ certification preferred.
Six Sigma Green Belt or Black Belt certification preferred.
Strong written and verbal communication skills.
Ability to work effectively with suppliers, internal stakeholders, and cross-functional teams.
Strong documentation, investigation, and problem-solving skills.
Ability to manage multiple priorities in a regulated manufacturing environment.
Ability to travel up to 10% to 20%

Compensation

The anticipated salary range for this position is $100,000 – $115,000 annually, depending on experience, qualifications, and internal equity.

Equal Employment Opportunity

Sonablate Corp. provides equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity, national origin, age, disability, genetic information, marital status, amnesty, veteran status, or any other status protected by applicable federal, state, or local law.

Pay: $100,000.00 - $115,000.00 per year

Benefits:

401(k)
Dental insurance
Health insurance
Paid time off
Vision insurance

Work Location: Hybrid remote in Indianapolis, IN 46226

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Refine Your Search

supplier quality development engineer jobs

Supplier Quality Engineer

Quality Engineer

Materials Applications Engineer

Quality Engineer

Electrical Engineer – Smart Health & Wearable Devices

Metallurgical Engineer

Refrigeration Engineer

Sr. Systems Development Engineer , Secure Connection Services (SCS), Tactical Edge Mission Engineering Group (TEMEG)

Project Engineer

Customer Engineer

Environmental Project Professional, Las Vegas

Product Engineer

Business Development Manager (Applications Sales Engineer)

Operations Process Engineer - West Region

Project Engineer / Assistant Project Manager

Process Engineer

Engineer III - EDI

Manufacturing Excellence Leader

Quality Engineer

Quality Engineer

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