Quality Management Systems Specialist

Quality Management Systems Specialist

Location: Remote (occasional site visit to Dublin may be required)

Duration: 12 months

Hours: 39 per week

Hourly rate: Competitive hourly rate (PAYE, Umbrella and Ltd options available)

Johnson & Johnson is recruiting for a Quality Management System Specialist in the Johnson and Johnson Medtech division. This is an exciting role involving the integration of a new acquisition into J&J and ensuring support for their Quality Management System compliance to large regulations. 

As a Quality Management System Specialist, you will join Johnson and Johnson’s Emerging Standards and Regulations Integration team supporting the integration of standards and regulations for a key MedTech business, ensuring supply continuity to our customers and patients.  

The role is responsible for leading gap assessments, quality planning and gap remediation through new process implementation or procedure creation/updates/integration for the ESRI Program. This role will work with key senior business leads across Johnson & Johnson MedTech to support the integration of this acquisition and their path to compliance.

roles and responsibilities

• Conducting gap assessments in an efficient and timely manner against large MedTech regulations for the business by sourcing their procedures and gaining an understanding of their processes

• Identifying risks and escalations as part of the program process

• Clarifying and verifying gaps with business SMEs to understand remediation steps

• Identifying process owners to close all identified gaps

• Create Quality Plans, as required, per the project strategy

• Generate associated Interim Reports, as needed, to support project progress

• Close out Quality Plans, as required

• Update trackers showing status and completion of activities

• Work with the project team and business stakeholders to document status and completion of activities in the appropriate trackers and implementation project plans

how to succeed

• 5+ Years relevant experience in MedTech

• 5+ Years Quality Systems experience required

• Familiar with quality tools and problem-solving techniques

• You will have experience with MedTech regulations such as EU MDR, Swiss MedDO and other GXP standards and regulations

• Exceptional communication skills to allow you to work effectively across various levels and teams

• Strong documentation and communication skills

• Proactive, independent and committed, with a can-do attitude which will enable you to build effective relationships and networks locally/regionally.  

• You will be able to make complex issues clear and transparent and be a strong problem solver.  

• You will have wide Quality Systems experience and be able to work effectively across many different functions 

• You will have a strong sense of personal responsibility and be able to work both as an individual leader and be a strong team player 

benefits

This role offers a very competitive hourly rate. This contract will run for 12 months and has a chance of contract extension.

you are welcome here

Johnson & Johnson is working to create an inclusive environment where diverse backgrounds, perspectives, and experiences are valued and each and every one of our people feels that they belong and can reach their potential. No matter who they are.

About Johnson & Johnson MedTech

At Johnson & Johnson MedTech, we unleash diverse healthcare expertise, purposeful technology, and a passion for people to transform the future of medical intervention and empower everyone to live their best life possible.

For more than a century, we have driven breakthrough scientific innovation to address unmet needs and reimagine health. In surgery, orthopaedics, vision, and interventional solutions, we continue to help save lives and create a future where healthcare solutions are smarter, less invasive, and more personalised.

https://www.jnj.com/healthcare-products/medtech

application process

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. 

We are accepting applications from Ireland only.

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”.