Senior Lifecycle Quality Engineer
Johnson & Johnson
full-time
Posted on:
Location Type: Hybrid
Location: Ciudad Juarez • Mexico
Visit company websiteExplore more
Job Level
About the role
- Provides leadership in design and implementation of world-class quality engineering to support entire product life cycle with focus on quality engineering activities such as reliability, risk management, analytics/statistical techniques, requirements management, verification & validation, and design control across the lifecycle of the product.
- Provides complex product team support for quality system design and audit, compliance assessment, and for support of steady state manufacturing processes.
- Reviews and edits all engineering documentation related to assigned projects, such as technical reports, work instructions and method and process validation; provides review and approval for the release of new products and design changes ensuring quality requirements are met.
- Addresses and corrects product and process complaints through data analysis, continuous product improvement, and/or corrective and preventive actions.
- Studies specifications, engineering blueprints, tool orders, and shop data and confers with engineering and shop personnel to resolve design problems related to material characteristics, dimensional tolerances, service requirements, manufacturing procedures, and cost.
Requirements
- A bachelor's degree in engineering from an accredited engineering or relevant science/technical school is required.
- Generally requires minimum of 4 years’ work experience.
- Experience in a regulated industry (medical technology, pharmaceutical, or biotechnology) or veterans with leadership experience will be given preference.
- Experience with Risk Management (ISO 14971), Medical Device Quality Management System (ISO 13485), Gage repeatability and reproducibility theory and application, statistics, project management (supporting multiple projects simultaneously), and reliability is strongly preferred.
- Auditing skills such as - ISO, QSR (Quality Systems Regulations), MDSAP, and GMP standards are preferred.
- An ASQ certification (CQE, CQM, CRE or CQA) is an asset.
- Six Sigma (Green Belt, Black Belt, etc.) or Process Excellence certification is an asset.
- Candidates must be fluent in English, for both written and oral communication.
Benefits
- Health insurance
- Professional development.
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
quality engineeringrisk managementanalyticsstatistical techniquesrequirements managementverification and validationdesign controldata analysiscontinuous product improvementproject management
Soft Skills
leadershipcommunicationproblem-solvingcollaborationattention to detail
Certifications
ASQ CQEASQ CQMASQ CREASQ CQASix Sigma Green BeltSix Sigma Black Belt