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

JOB 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/
J&J MedTech is recruiting for a Quality & Compliance Staff Engineer reporting to the Quality Operations Manager and to be based in Cork (Ireland).

JOB SUMMARY

The Quality & Compliance Staff Engineer devises or adapts new methods or procedures to control or coordinate all aspects of several projects simultaneously and in the solution of technical and related projects.
The Quality & Compliance Staff Engineer is an emerging authority in a specific technical field, exercising considerable latitude in determining technical objectives of assignments. Work is generally expected to result in the development of new or refined methods to reduce risk, equipment, materials, processes, products and or technical methods.
The Quality & Compliance Staff Engineer will utilize Quality tools and practices for the effective and efficient development, transfer, and maintenance of products/processes throughout the product lifecycle.
The incumbent will also utilize Quality Engineering principles and problem-solving skills to improve and maintain products/processes that are aligned with the overall Quality and Business vision.
They will utilize appropriate risk management to prevent unanticipated failure modes and improve capability of processes.
This person will support processes in Base Business and supervise and lead projects and initiatives, as well as lead, mentor and support team members.

PRODUCT/PROCESS QUALIFICATION

• Approve IQ, OQ, PQ, TMV or Software Validation

EXPERIENCE AND EDUCATION

• Degree qualified in a relevant Engineering/Science discipline, and/or 5+ years relevant experience in the Medical Device industry or medical field.
• Demonstrated leadership skills and the ability to make effective decisions.
• Experience in regulated industry, FDA, ISO, etc.
• Proven track record of successfully delivering projects.
• Self-motivated, with focus on Quality, Delivery and Cost.
• Previous people management experience
• Certification in Six Sigma or Statistical Engineering.
• Experience with a proven track record of implementing appropriate risk mitigation.
• Good technical understanding of manufacturing equipment and processes is required.

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

• Excellent Planning & Organisational Skills
• Strong project and people management, coaching and leadership skills are desired.
• The ability to perform “hands on” troubleshooting and problem solving is required.
• The ability to think on the feet and providing sound judgment is highly desired.
• Ability to manage multiple assignments or projects with sound analytical, troubleshooting, and problem-solving skills.
• Advanced knowledge and proven leadership in the areas listed in the Duties and Responsibilities associated with the position.
• Demonstrated project management and project leadership abilities are required.
• Flexible work ethic.
• Strong influencing skills.
• Excellent communication and presentation skills.
• Good Problem-Solving skills.
• Drive, energy and enthusiasm for delivering to commitments.
• Excellent planning & organisation skills with an attention for detail.
• Understanding of the NPI (New Product Introduction) process and Process Validation expertise is preferred.
• A thorough understanding of GMP/ISO regulations and validation regulations is preferred.

LOCATION & TRAVEL REQUIREMENTS

• This position may require up to 20% travel and will be based in an MD&D manufacturing facility.

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

• Responsible for communicating business related issues or opportunities to next management level.
• Responsible for following all Company guidelines related to Health, Safety and Environmental practices 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.