Senior Quality Engineer

Johnson & Johnson; Galway; On-site; EUR 4,133,000 - 6,612,000; Full time

Benefits offered by this job

Competitive hourly rate

Job summary

Johnson & Johnson MedTech, specifically the Cerenovus division, is seeking a Design Quality Engineer to strengthen design control and risk management across product design and manufacturing. You will apply six sigma and lean methods, and work with R&D, Regulatory, Supply Chain, and QA to uphold the quality system and enable compliant growth.

The role involves lifecycle management, root cause analysis, vendor support, and documenting design changes.

Qualifications

• A minimum of 4 years of related experience.
• Knowledge working in a highly regulated industry.
• Familiarity with ISO 13485, specifically Design Control.
• Interpersonal skills that promote conflict resolution in both personnel and technical contexts.
• Strong written and verbal communication skills to communicate effectively at all levels.
• Excellent problem solving/root cause investigation and decision-making skills.

Responsibilities

• Responsible for ensuring Design control and Risk Management activities, wherever they are performed comply with the requirements of the quality system.
• Executes Life Cycle Management projects in a cross-functional setting as the design quality engineer core team member.
• Works on complex problems and provides solutions which are highly innovative and comprehensive.
• Applies scientific and engineering knowledge to the development and improvement of medical device products, associated processes, and manufacturing equipment as well as associated validations.
• Works independently and in cross-functional teams to determine root cause, develop mitigations and corrective and preventative actions for design, process, and manufacturing related issues.
• Utilizes the application of six sigma and lean tools and methodologies.

Skills

Communication skills

Problem solving

Teamwork

Interpersonal skills

Written communication

Education

Bachelor's degree in Engineering

Advanced degree preferred

Tools

Microsoft Project

FPX

Job description

Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments.

Your unique talents will help patients on their journey to wellness. Learn more at https://www.jnj.com/medtech

The position provides quality technical and compliance expertise as part of teams tasked with modifying existing designs, supplier changes, internal manufacturing support, and other lifecycle management activities. The use of engineering and supply chain knowledge to assist in the execution of cross-functional projects in support of the company’s strategies, goals, objectives, and product portfolio. Uses knowledge of scientific techniques and process excellence to modify/ develop and validate safe, effective, and efficient processes.

Provides technical support to ensure continuity of supply. Assures compliance to applicable regulations and leads quality activities such as risk assessments, device testing, audits, procedure development, documentation review and changes to controlled documents. Provides design control, risk management, and compliance support for product design and manufacturing, corrective and preventive actions, product/process improvements and complaint investigations.

Responsible for supporting the Design Changes of products in compliance with the Cerenovus, Inc. Quality System and in line with Johnson & Johnson policies and standards to enable compliant growth and the design/manufacture of robust high-quality products. Works closely with the R&D, Regulatory, Supply Chain, Clinical and Marketing functions in creating/maintaining quality systems for product design and ongoing business needs.

Roles and Responsibilities

• Responsible for ensuring Design control and Risk Management activities, wherever they are performed comply with the requirements of the quality system.
• Executes Life Cycle Management projects in a cross-functional setting as the design quality engineer core team member.
• Works on complex problems and provides solutions which are highly innovative and comprehensive.
• Applies scientific and engineering knowledge to the development and improvement of medical device products, associated processes, and manufacturing equipment as well as associated validations.
• Works independently and in cross-functional teams (both internal and external) to determine root cause, develop mitigations and corrective and preventative actions for design, process, and manufacturing related issues.
• Exercise judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions.
• Evaluates manufacturing processes / products and collaborates with R&D, NPI, Sourcing, QA, Manufacturing and Finance teams to lead projects / initiatives to improve quality, productivity and reduce costs.
• Utilizes the application of six sigma and lean tools and methodologies.
• Ensures quality conduct of projects including design, data summary and interpretation, reports and review compliance to applicable regulations.
• Generate written reports and provide technical expertise to related projects.
• Provide technical support for outside suppliers, vendors, and/or consultants as required.
• Provide guidance and work direction to other engineers and related project team members.
• Responsible for communicating business related issues or opportunities to next management level.
• Responsible for ensuring personal and Company compliance with all International, Federal, State, local and Company regulations, requirements, policies, and procedures.
• Performs other duties assigned as needed.

How to Succeed

Education:

• A minimum of Bachelor’s or equivalent degree in Engineering or area of Scientific discipline is required; An advanced degree is preferred.

Experience and Skills:

Required:

• A minimum of 4 years of related experience.
• Knowledge working in a highly regulated industry.
• Familiarity with ISO 13485, specifically Design Control.
• Interpersonal skills that promote conflict resolution in both personnel and technical contexts.
• Strong written and verbal communication skills to communicate effectively at all levels.
• Excellent problem solving/root cause investigation and decision-making skills.

Preferred:

• Medical device industry experience.
• Manufacturing process IQ, OQ, PQ qualifications as related to medical devices.
• Working knowledge of applicable requirements related to the MDSAP jurisdictions.
• Strong project management skills (Microsoft Project, FPX and/or other project management tools).

This role offers a very competitive hourly rate. This contract will run for 12 months.

about Cerenovus

Cerenovus is part of Johnson & Johnson MedTech and an emerging leader in neurovascular care. Our commitment to changing the trajectory of stroke is inspired by our long heritage and dedication to helping physicians protect people from a lifetime of hardship. At Cerenovus we offer a broad portfolio of devices used in the endovascular treatment of hemorrhagic and ischemic stroke. Contribute to the next healthcare breakthrough with your next project at Cerenovus.

https://www.jnjmedtech.com/en-US/companies/cerenovus

Diversity, Equity & Inclusion

For more than 130 years, diversity, equity & inclusion (DEI) have been part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Our commitment to respect the dignity and diversity of all is embedded in our Credo.

We know that the success of our business depends on having the best talent in a workforce that reflects the diverse markets we serve around the world and an inclusive culture that values different perspectives and life experiences. That is why we are working to create an inclusive environment where diverse backgrounds, perspectives and experiences are valued and each one of our people feels that they belong and can reach their potential. No matter who they are. Diversity, Equity & Inclusion at Johnson & Johnson means “You Belong”.