Sr. Supplier Quality Engineer - Shockwave Medical

Johnson & Johnson MedTech; Santa Clara (CA); On-site; USD 89,000 - 143,000; Full time

Job summary

An established industry player is seeking a Sr. Supplier Quality Engineer to enhance its innovative medical solutions. This role involves managing supplier quality, ensuring compliance with regulatory standards, and collaborating across functions to improve processes. You'll be pivotal in driving quality improvements and supporting manufacturing operations for cutting-edge medical devices. If you have a passion for quality engineering and a desire to make a significant impact in healthcare, this opportunity is tailored for you.

Benefits

Performance Bonuses

Comprehensive Benefits

Retirement Plans

Paid Time Off

Qualifications

• 5+ years of experience in supplier quality management or related field.
• Strong understanding of regulatory standards in the medical device industry.

Responsibilities

• Manage supplier performance and resolve quality issues.
• Support manufacturing operations and conduct supplier audits.

Skills

Supplier Quality Management

Risk Management

Process Improvements

Technical Writing

Statistics

Six Sigma

Lean Methodologies

Communication Skills

Education

BS in Engineering

MS in Engineering

Tools

cGMP

FDA 820 QSR

ISO 13485

Job description

Sr. Supplier Quality Engineer - Shockwave Medical

Join to apply for the Sr. Supplier Quality Engineer - Shockwave Medical role at Johnson & Johnson MedTech.

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com.

Job Function

Supply Chain Engineering

Job Sub Function

Quality Engineering

Job Category

Scientific/Technology

Location

Santa Clara, California, United States of America

Job Description

Johnson & Johnson is hiring a Sr. Supplier Quality Engineer – Shockwave Medical in Santa Clara, CA. We are developing innovative solutions like Intravascular Lithotripsy (IVL) for treating complex calcified cardiovascular disease, aiming to set new standards in medical device treatment of atherosclerotic conditions.

Position Overview

The Sr. Supplier Quality Engineer supports manufacturing operations, manages suppliers, and collaborates across functions to resolve quality issues. Responsibilities include scope of work decisions, risk management, process improvements, material disposition, and updating product specifications.

Essential Job Functions

Supplier Management

• Partner with Procurement, R&D, Operations, Quality, and Suppliers to investigate, resolve, and prevent supplier quality issues.
• Monitor supplier performance metrics, identify improvement opportunities, and communicate risks or opportunities.
• Plan, execute, and report on supplier audits; review and approve SCARs and SCAs; drive root cause analysis and corrective actions.
• Participate in component qualification change projects and analyze supplier performance data.

Manufacturing Support

• Investigate and resolve NCRs and CAPAs; review DCOs; support internal and third-party audits; participate in MRB meetings.

Manufacturing Line Transfers

• Collaborate on requirements and documentation for transferring manufacturing lines to CMs; provide training and support.

Qualifications

• BS in engineering + 5+ years, or MS + 3+ years of relevant experience.
• Experience in the medical device industry preferred; strong understanding of cGMP, FDA 820 QSR, ISO 13485.
• Technical writing, communication skills, proactive attitude, ability to work independently, and experience with statistics, Six Sigma, Lean.
• Certifications such as CQE, Lead Auditor, Six Sigma, Project Management are a plus.
• Ability to lift up to 25 lbs and travel up to 20%.

Pay Range & Benefits

Salary: $89,000 - $142,600. Includes performance bonuses, comprehensive benefits, retirement plans, time off, and more. Details at https://www.careers.jnj.com/employee-benefits.

Equal Opportunity Employer

Johnson & Johnson values diversity and inclusion. We provide accommodations for applicants with disabilities upon request.