Medical Devices Sourcing jobs

Senior Supplier Quality Engineer

Location: Galway

Duration: 12 months

Hours: 40

Participate, support, and lead activities related to external suppliers of raw material, components, finished devices and services for the inspection of incoming materials, implementation of corrective/preventive actions, validations, certifications, qualifications and any project related to quality improvement.

This position has responsibilities on Ethicon and Cardiovascular and Specialty Solution (CSS) Family of Johnson and Johnson companies, including multiple product platforms such as General Surgery Medical Devices, Sutures, ENT, Infection Preventions Electrophysiology, Neurovascular, Esthetic Surgical and non-surgical devices.

Roles and Responsibilities

• Supports different business units on the company, following up on situations related to supplier quality.

• Support the incoming inspection group (technician, team lead supervisor, etc.) on the decision-making process and follow up of material nonconformance with suppliers.

• Responsible to coordinate supplier investigations, related to material non-conformances.

• Participate in the investigation process and risk analysis of non-conformances caused by suppliers.

• Works directly with suppliers and external manufacturers to ensure the products and services received meet requirements and/or specifications.

• Responsible for approving and/or escalating deviations on product specifications or processes from suppliers.

• Responsible for generating corrective and preventive actions to suppliers, and verification of the effectiveness of such actions for approval and closure

• Collect and distribute supplier performance data.

• Support suppliers on the implementation of improvement plans (example SPC, Gage R&R, etc.).

• Support and lead initiatives to improve suppliers’ performance in order to certify them or reduce receiving inspection activities.

• Participate in the analysis of complaints related to suppliers.

• Interact with other groups (Sourcing, R&D, LCM, Engineering, etc.) for the process of supplier selection.

• Visit and evaluate suppliers through audits or technical assessments.

• Develop and implement improvement programs for suppliers.

• Support the Quality Audit group providing quality metrics and supplier performance data.

• Participate and support the introduction of new products in relation to new components or finished devices provided by suppliers.

• Supports the qualification, validation and certification of supplier's inspections methods and equipment.

• Responsible for the generation or updates to Supplier Quality Agreements.

• Participate with other functional groups and support activities related to changes requested by or to suppliers.

• Responsible to review, create and approve changes to company procedures, work instructions, forms, inspection reports and other related controlled documentation.

• Complete all training on time assigned by the quality compliance department.

• Responsible for follow ups, implementation and closure of company corrective and preventive actions either internal or external.

• Attend and participate in quality metric reviews.

• Participate in different projects like Kaizen, PE (GB/BB) and lean.

• 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

• Bachelor’s degree in an engineering discipline is required.

• Professional experience of 5+ years in a related industry are required.

• 5+ years of experience in Quality Assurance working with suppliers is required.

• Strong knowledge on corrective and preventive action systems (CAPA).

• Basic knowledge on statistical analysis and problem-solving techniques.

• Basic knowledge of project management tools. Experience implementing tools in desired.

• Strong understanding of GMP, QSR, ISO 13485 requirements.

• Experienced with validation certification and auditing of suppliers.

• Understands specification drawings and departmental procedures.

• Knowledge of document control systems, preferably ADAPTIV, ETQ and JDE.

• Understands six sigma toots, preferably Green Belt certified or higher.

• Works under minimum supervision and takes self-directed action.

• Ability to negotiate and mentor other engineers.

• Ability to take actions as needed based on J&J Credo

Benefits

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

Application Process

We are looking to process the first round of applications within the next 2 working days.

We do not accept applications via email. The pay rate for this role will depend on how you are paid. PAYE, LTD & Umbrella options are available.

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”.