Senior Quality Engineer

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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 teams capabilities.

EXPERIENCE AND EDUCATION

• Bachelors 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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