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Johnson & Johnson · 2 days ago

Experienced Supplier Quality Engineer

Bradley, WV

Full-time

Onsite

Entry, Mid Level

2+ years exp

Johnson & Johnson is a leader in healthcare innovation, committed to improving health outcomes through advanced solutions. The Experienced Supplier Quality Engineer will ensure the quality and compliance of materials and processes supporting medical device products, leading supplier qualification and performance management activities.

Hospital & Health Care

Comp. & Benefits

H1B Sponsor Likely

Responsibilities

Provides quality engineering leadership in the management of select contract manufacturing and supplier sites engaged in the production and delivery of Johnson and Johnson products and services

Responsible for technical leadership in establishing quality expectations at the supplier, to include process changes in partnership with Source Quality and New Product Development (NPD) Teams

Partner with NPD team to support successful launches at suppliers

Conduct supplier visits emphasizing quality improvement and compliance with good manufacturing practices, ISO and other applicable standards

Provide product team support for quality system requirements and supplier auditing, compliance assessment, and for support of sustaining manufacturing processes

Provide Quality Engineering support to suppliers including inspection technique support, product non-conformances, verification/validation activities, CAPA and change management

Address and support investigation of product issues to include product and processing complaints

Apply industry and process excellence tools and standards in daily quality operation activities, to include Good Manufacturing Practices (GMP), equipment engineering system (EES), and ISO

Report on supplier performance metrics during quality and management reviews

Lead supplier visits to assess compliance to process excellence standards

Ensure comprehensive measurement systems to monitor effectiveness of quality and reliability. Identify, bracket, correct and prevent defects. Present reports to management

Evaluating and implementing improved manufacturing engineering performance management systems and tracking tools, as well as facilitating resolution of complex technical, quality and operational problems

Responsible for communicating business-related issues or opportunities to next management level

Responsible for following all Company guidelines related to Health, Safety and Environmental practices as applicable

For those who supervise or manage a staff, responsible for ensuring that subordinates follow all Company guidelines related to Health, Safety and Environmental practices and that all resources needed to do so are available and in good condition, if applicable

Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures

Performs other duties assigned as needed

Qualification

GMP/GDP knowledgeFDA/ISO regulationsSupplier auditsCAPA processesCertified Quality EngineerSix Sigma certificationAnalytical ReasoningProblem SolvingCross-Functional CollaborationCommunication

Required

University Bachelor' degree in science, engineering, or related field

2 to 4 years' experience in a highly regulated industry is required

Strong knowledge of GMP/GDP, FDA/ISO regulations, and a robust Quality Management System

Demonstrated experience managing supplier nonconformance, CAPA, and change control processes

Direct experience performing supplier audits and supplier quality system assessments

Demonstrated problem-solving skills with root-cause analysis and familiarity with CAPA processes (8D, PDCA, etc.)

Excellent written and verbal communication skills; proven ability to interact with suppliers and cross-functional internal stakeholders

Ability leads to change, drive reliability, and foster a culture of quality and safety

Preferred

Certified Quality Engineer (CQE), Certified Quality Auditor (CQA), Six Sigma Black/Green Belt, or equivalent certification is desired

Analytical Reasoning

Business Behavior

Coaching

Compliance Management

Controls Compliance

Cross-Functional Collaboration

Data Compilation

ISO 9001

Issue Escalation

Persistence and Tenacity

Problem Solving

Quality Control (QC)

Quality Standards

Quality Systems Documentation

Report Writing

Technologically Savvy

Vendor Selection

Company

Johnson & Johnson

Glassdoor4.2

At Johnson & Johnson, we believe health is everything.

Founded in 1886

New Brunswick, NJ, US

10001+ employees

http://www.jnj.com

H1B Sponsorship

Johnson & Johnson has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)

Distribution of Different Job Fields Receiving Sponsorship

Represents job field similar to this job

Trends of Total Sponsorships

2025 (48)

2024 (56)

2023 (58)

2022 (59)

2021 (44)

2020 (27)