Quality Engineer

Quality Engineer – Johnson & Johnson MedTech

Join to apply for the Quality Engineer role at Johnson & Johnson MedTech . We believe health is everything and are committed to building innovative healthcare solutions that improve lives.

Job Summary

The Quality Engineer shares a passion for ensuring the highest quality experiences for our patients and customers. This position will lead Design Controls, Product & Process Validation, Risk Management, and Lifecycle Management for the Wound Closure and Healing (WCH) or the Biosurgery Platforms.

Duties & Responsibilities

• Demonstrate growing proficiency in applying tools and methods (e.g., Six Sigma, Lean) to identify and realize new product or process introductions as well as process and business improvements.
• Apply risk management and risk mitigation tools and practices (e.g., mistake proofing, critical control points, failure modes and effects analysis).
• Contribute to the reliability assessments of product design.
• Lead root‑cause investigations using problem‑solving techniques and tools, assessing the effectiveness of corrective actions.
• Support the development of test methods in equipment, process, and product qualifications/validations, and execute methods as needed.
• Implement and maintain production and process controls using appropriate techniques such as process capability measures, statistical process controls and process performance metrics.
• Support execution of project plans as a contributing member of the team.
• Communicate business‑related issues or opportunities to the next management level.
• Adhere to all Company guidelines related to Health, Safety and Environmental practice.
• Ensure subcontractors and staff follow all applicable guidelines and that resources are available and in good condition.
• Ensure personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures.
• Perform other duties assigned as needed.

Experience & Education

• Bachelor’s Degree in engineering, science or related technical field from an accredited institution. A relevant advanced degree is preferred.
• 2 – 4 years of work experience in a regulated industry (medical device, bio‑pharmaceutical, or pharmaceutical) is expected.

Required Knowledge, Skills, Abilities, Certifications, Licences & Affiliations

• Knowledge of ISO13485 and/or cGMP regulations.
• ASQ certification (CQE, CQM, CRE, or CQA), Six Sigma (Green Belt, Black Belt, etc.), or Process Excellence certification is preferred.
• Independent understanding and application of core GMP fundamentals, including Data Integrity (DI), Good Manufacturing Practices (GMP), and Good Documentation Practices (GDPs).
• Ability to perform applied statistics, design control, documentation, manufacturing practices, organizational requirements, root cause analysis, CAPA, measurement system analysis and reliability testing.
• Computer skills in Windows, word processing, project planning, presentation, e‑mail and spreadsheet software; use of additional software packages as required.

Additional Position Requirements

• Ability to work in scheduled work hours.
• Ability to work in a stressful/fast‑paced environment.
• Ability to work and interact with co‑workers to accomplish company goals in a team environment.
• Strong analytical/problem‑solving skills.
• Willingness to learn and adapt.
• Excellent verbal and written communication skills.
• Comfortable sitting for long periods, standing and walking moderately.
• Repetitive hand motions – computer entry.
• Compliance with local regulations and Company guidelines related to Health, Safety and Environmental practices.

Responsibility for Others & Internal Interactions

Works in collaboration with all other departments to ensure quality and compliance aspects are incorporated and maintained related to quality engineering and validation.

Location & Travel Requirements

• Primary location: within an Ethicon, Inc site, globally (Norderstedt, Schleswig-Holstein, Germany).
• Certain tasks can be performed remotely.
• Travel approx. 10% domestic and international.

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