Commercial Quality Specialist

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 Function:
Quality

Job Sub Function:
Customer/Commercial Quality

Job Category:
Professional

All Job Posting Locations:
Leeds, West Yorkshire, United Kingdom

Job Description:

About MedTech

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

We are searching for the best talent for Commercial Quality Specialist to be in Leeds.

Purpose:

Responsible for the execution of Commercial Quality related processes for training, change control and document control in a flawless and compliant way within the UK / Ireland Local Operating Company (LOC) and Johnson & Johnson Managed Service (JJMS).

You will be responsible for:



* Ensuring compliance to all applicable quality standards & regulatory requirements in the UK/Ireland LOCs and JJMS.


* Supporting documentation of the Quality Management System (QMS) processes in the document management system and assisting other departments to ensure documents are maintained.


* Support training activities – including maintenance & implementation of the training matrix, development and issuance of training metrics on a regular basis


* Owning, tracking and conducting non-conformances and CAPA investigations and document in the appropriate systems using approved tools.


* Ability to work alone but part of a virtual team.

Working independently to resolve quality issues locally or where applicable with appropriate escalation


* Performing Internal audits as per the UK/Irl, JJMS or EMEA schedule


* Managing & leading change control activities as applicable


* Supporting Monthly metric generation & collate data for Quality Management Review


* Acting as records coordinator for UK / Irl LOC


* Being an EMEA Subject Matter Expert to support the Commercial Quality EMEA team as required

Qualifications / Requirements:



*  A minimum of 5 years experience of working in a Medical Devices environment or other regulated environment


* Excellent written and oral English communication skills


* Good collaboration skills and ability to work independently with internal partners


* Demonstrate Leadership behaviours expected by J&J Credo and Leadership Principals


* Good System & Computer knowledge (Excel, Word,...