Quality Engineer

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 : / /

Job Function :

R&D Product Development

Job Sub Function :

Biomedical Engineering

Job Category :

Scientific / Technology

All Job Posting Locations :

Norderstedt, Schleswig-Holstein, Germany

Job Description :

Internal Posting

TARIFF

JOB SUMMARY

The Quality Engineer shares a passion for ensuring the highest quality experiences for our patients and customers.

This position will be responsible for the leadership and support of Quality Engineering activities pertaining to Design Controls, Product & Process Validation, Risk Management, and Lifecycle Management for the Wound Closure and Healing (WCH) or the Biosurgery Platforms.

WCH is a market leader in surgical tissue healing with a broad portfolio including Antibacterial sutures, Knotless Tissue Control Devices, Topical Skin Adhesives, Skin Closure Systems, and traditional absorbable and non-absorbable surgical sutures with innovative needle technologies.

The Biosurgery Platform consists of a comprehensive portfolio of adjunctive hemostats and sealants.

DUTIES & RESPONSIBILITIES

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

• Demonstrating growing proficiency in applying various tools and methods (for example, Six Sigma, Lean) to identify and realize new product or process introductions as well as process and business improvements.
• Demonstrating growing proficiency in applying various risk management and risk mitigation tools and practices (for example, mistake proofing, critical control points, failure modes and effects analysis).
• Contributing to the reliability assessments of product design.
• Contributing to root cause investigations using various problem‑solving techniques and tools and assessing the effectiveness of corrective actions.
• Supporting the development of test methods in equipment, process, and product qualifications/validations; executing methods as needed for development and qualification.
• Implementing and/or maintaining production and process controls using appropriate techniques (for example, process capability measures, statistical process controls, and process performance metrics).
• Supporting execution of project plans as a contributing member of the team.
• Responsible for communicating business‑related issues or opportunities to next management level.
• Responsible for following all company guidelines related to health, safety and environmental practice (as applicable).
• For those who supervise or manage a staff, responsible for ensuring that subordinates follow all company guidelines related to health, safety and environmental practices and that all resources needed to do so are available and in good condition (if 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.

EXPERIENCE AND EDUCATION

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

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

• Knowledge of ISO13485 and / or cGMP regulations.
• An ASQ certification (CQE, CQM, CRE, or CQA), Six Sigma (Green Belt, Black Belt, etc.), or Process Excellence certification is preferred.
• Demonstrate independent understanding and application of core GMP fundamentals, including but not limited to Data Integrity (DI), Good Manufacturing Practices (GMP), and Good Documentation Practices (GDPs).
• Technical quality areas: applied statistics of increasing complexity, design control, good documentation practices, good manufacturing practices, organizational requirements, root cause analysis and CAPA, measurement system analysis (MSA) and reliability testing/analysis under guidance.
• Personal computer skills: Windows – word processing, project planning, presentation, e‑mail, and spreadsheet software; learn and apply software packages as required.

ADDITIONAL POSITION REQUIREMENTS

• Ability to work in scheduled work hours.
• Ability to work in stressful / fast paced environment.
• Ability to work and interact with co‑workers to accomplish company goals in a team environment.
• Analytical / Problem Solving Skills.
• Ability to learn.
• Ability to communicate verbally and in writing.
• Must be able to sit for long periods of time with a moderate amount of standing and walking.
• Ability to do repetitive hand motions – computer entry.
• Must follow applicable local regulations & 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

• The primary location for the position is within an Ethicon, Inc site, globally.
• – certain task(s) can be performed remotely.
• Travel is approximately 10% and may include domestic and international.

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