Senior Quality Engineer

Description

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

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Position Job Title: Senior Quality Engineer

Scope: Ethicon, Mentor LLC

JOB SUMMARY

• Use Quality Engineering principles, tools and techniques to develop, optimize, and support systems and processes that are aligned with the overall Company strategy and mission affecting continuous quality improvement.
• Responsible for developing, modifying, applying and maintaining quality evaluation and control systems/protocols. Devises and implements methods and procedures for inspecting, testing and evaluating the precision and accuracy of products and production equipment. Designs and analyzes inspection and testing processes, mechanisms and equipment.
• Conducts quality assurance tests and performing statistical analysis to assess the level of control and manage product quality risks.
• Undertakes root cause analysis of incidents requiring corrective action.
• Ensures that corrective measures and deviation meet acceptable reliability standards and that documentation is compliant with requirements.

DUTIES & RESPONSIBILITIES

Under limited supervision and in accordance with all applicable federal, state and local laws/regulations and Corporate Johnson & Johnson, procedures and guidelines, this position:

• Supports, consults, trains on, and leads quality improvement projects throughout the life cycle of Mentor products this includes product design and development, manufacturing, purchasing and improvements.
• Utilizes statistical tools and techniques to establish sampling plans. Supports engineering activities in process and vendor specification development.
• Analyzes process-, product-, test- and Quality Management System data and investigates for improvement opportunities.
• Is responsible for pFMEA documentation and leading pFMEA meetings.
• Reviews validations documentation (eg. IQ, OQ, PQ and verification studies) for process and computer software validations.
• Leads or acts as team member for CAPA and Internal audit observation investigation and action plans.
• Investigates instances of nonconforming material and supports the determination of cause, corrective action and recommendation of the disposition of product.
• Ensures that software validations are performed according to applicable FDA guidelines. Provides end user support by software validation throughout the Software Validation Life Cycle at The Netherlands Operations.
• Is responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures
• Complies with all applicable environmental, safety and occupational health policies.
• Performs additional duties as assigned to support the Quality Engineering function.
• Demonstrates high autonomy.
• Leads significant projects, programs or initiatives.
• Mentors entry-level and mid-level engineers, helping to grow the team’s capabilities.

EXPERIENCE AND EDUCATION

• Bachelor’s degree (B.S.) in engineering, science, mathematics or statistics is required.
• Demonstrated knowledge of good manufacturing principles and practices, and procedures;
• A minimum of three years related manufacturing experience and/or training; or equivalent combination of education and experience is desired.

REQUIRED KNOWLEDGE, SKILLS, ABILITIES, CERTIFICATIONS/LICENSES and AFFILIATIONS .

• Pro Active
• Troubleshooting and Risk Assessment / Risk Management minded
• Tact
• High level of accuracy
• Flexible and Service minded
• Able to identify and simplify complex issues
• Communication skills
• Fluent in English
• Able to work on cross-functional teams is required.
• CQE certification, Six Sigma Greenbelt certifications are preferred to all Quality Engineer job levels.
• Able to communicate effectively within diverse interdepartmental groups.

ADDITIONAL POSITION REQUIREMENTS

• The employee performs routine office and operations demands including computer operation. Routine office and operations including computer usage are required.
• The position also requires occasional work in a clean room production environment which requires certain preparation and gowning practices.
• Ability to work and interact with co-workers to accomplish company goals in a team environment.

RESPONSIBILITY FOR OTHERS & INTERNAL INTERACTIONS

This position reports to Quality Operations Engineering Lead.

LOCATION & TRAVEL REQUIREMENTS

Primary location of the position – Mentor LLC, Leiden, The Netherlands;

Expected travel percentage for domestic, international, or both – less than 3% per year.

EXTERNAL INTERACTIONS

The position may require interactions as subject matter expert with government agencies, competent authorities, third part suppliers or customers of J&J.

Closing date: Tuesday 13th of January 2026.

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Preferred Skills: