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Johnson & Johnson · 11 hours ago

Experienced Quality Engineer

Bradley, WV

Full-time

Onsite

Entry, Mid Level

2+ years exp

Johnson & Johnson is a leader in healthcare innovation, dedicated to improving health through advanced solutions. The Experienced Quality Engineer will support the MedTech Orthopaedics business by ensuring quality and efficacy in manufacturing processes, conducting technical reviews, and leading risk management activities.

Hospital & Health Care

Comp. & Benefits

H1B Sponsor Likely

Responsibilities

Support new product introduction as part of design transfer

Support planning and execution of manufacturing process qualifications including IQ, OQ, PQ, Process Verification and Test Method Validation (TMV)

Ensure that all critical to quality (CTQ) features are identified and adequately addressed in control plan by qualified test methods

Lead risk management activities and develop process FMEAs to ensure that process risk has been fully assessed, appropriate risk controls implemented, and risk reduced as far as possible

Collect data and execute/conduct various analytical/statistical analysis and interpretation as part of process improvements and day-to-day support

Conduct investigation, bounding, documentation, review and approval of non-conformances, CAPAs and customer complaints. Escalation of quality issues as appropriate

Analyze/review effectiveness of preventive and corrective actions. Review root cause investigation according to an established process

Support quality improvement initiatives such as process and product characterizations that lead to continuous / cost improvements

Review/analyze the effectiveness of PDCA, Six Sigma, Kaizen, Lean Techniques and/or other improvement tools and programs

Conduct benchmarking to develop more effective methods for improving quality

Review/analyze whether current product and processes (including actions or decisions conducted) are in compliance to standards such as the QSRs, ISO 13485, etc

Champions compliance to applicable Global Regulations and standards (e.g. QSRs, ISO, EN and Medical Device Directive (MDD) requirements) including providing support during internal and external audits

Conduct periodic line audits to assess for production controls such as lot segregation. Review results of area audits to ensure that corrective and preventive actions are adequate

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

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

Quality Management Systems (QMS)Process Verification / ValidationRisk ManagementSix SigmaLean TechniquesData AnalysisCoachingCompliance ManagementCommunication skillsProblem SolvingInterpersonal skillsDetail-Oriented

Required

A minimum of a University bachelor's degree, preferably in engineering: Mechanical, Electrical, Industrial or applicable science

2 - 4 years experience as a Quality Professional in the Medical Device Industry required

Demonstrated knowledge of manufacturing principles and practices, and procedures

Excellent communication skills in English, spoken and written

Ability to perform “active involvement” in the solution of problems and resolution of problems, preferably

Capacity to solve problems providing good judgment is highly desired

Experience conducting Process Verification / Validation

Experience leading risk management activities and developing associated documentation, such as Failure Modes & Effects Analysis

Interpersonal skills that foster collaboration as it relates to technical situations

Strong initiative and follow-through in completing responsibilities, overcoming obstacles and balancing multiple priorities effectively through strong technical and/or leadership experience

Preferred

Experience with inspection & test methods including GD&T

Experience working with ERP systems and associated Quality process flows (SAP, MES and Windchill knowledge preferably)

Strong experience with Six Sigma or Lean

Certifications such as CQA, CQE, CQM (preferably), CBA, MBB or BB are a plus

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)