Quality Systems Project Manager

Quality Systems Project Manager

Location: Ireland

Working mode: Remote (1-2 F2F meetings with the team per year)

Duration: 12 months (opportunity for an extension + permanent role)

Hours: 39 hours per week

Travel: Up to 10%

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

Imagine your next project as Quality Systems Project Manager. The Quality Systems Project Manager for EUDAMED will oversee the creation & implementation of the QMS process for EUDAMED in JNJ Medtech. The role requires a comprehensive understanding of regulatory requirements, strong technical writing skills, strong project management skills, and the ability to coordinate cross franchise teams to ensure compliance with EUMDR & IVDR.

roles and responsibilities

• Develop & manage project plans , timelines and budgets .

• Co-ordinate with internal and external stakeholders to ensure all milestones are met

• Identify , manage and mitigate project risks and issues.

• Ensure the organisations data submissions to EUDAMED comply with EUMDR requirements.

• Stay updated on regulatory changes and provide guidance on EUDAMED – related compliance matters.

• Collaborate with quality assurance, IT and other relevant departments to ensure seamless integration and operation of EUDAMED processes.

• Develop and deliver change management processes to maintain data integrity

how to succeed

• A minimum of a Bachelor’s Degree, preferably in Engineering or related technical field. Generally, requires 10 years related experience.

• Experience working in both an FDA and European regulatory environment is preferred.

• This position will require relevant experience working in manufacturing/operations.

• In-depth knowledge of product/process Risk Management (FDA and ISO standards) is required.

• Experience with a proven track record of implementing appropriate risk mitigation.

• Technical training and experience using Statistics, Lean and Six Sigma Methodologies is preferred including Measurement System Analysis, SPC, DOEs, Reliability, etc.

• Strong knowledge of statistical software packages is preferred with the ability to preview, graph and analyse data and be able to present data that facilitates/drives decision making.

• The ability to perform "hands on" troubleshooting and problem solving is preferred. The ability to think on the feet and providing sound judgment is highly desired.

• 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.

• Advanced knowledge and experience in the areas listed in the Duties and Responsibilities associated with the position.

• Demonstrated project management and project leadership abilities are preferred.

• This position may require up to 10% travel

benefits

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

Caring for the world, one person at a time has inspired and united the people of Johnson & Johnson for over 130 years. As a skilled contractor, you’ll play a key part in the thinking, strategy, dynamism - and impact - of this iconic global healthcare company as they touch the lives of nearly a billion people every day. Contribute to the next healthcare breakthrough with your next project at Johnson & Johnson.

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. 

questions

If you would like some additional information about the role please contact: sara.marsalo@randstadsourceright.co.uk (please note that we do not accept applications via email).

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”.