Commercial Quality Specialist

5 days ago

Leeds, United Kingdom Johnson & Johnson Full time

**Job Function**:
Quality

**Job Sub**Function**:
Customer/Commercial Quality

**Job Category**:
Professional

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

**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.

**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, PowerPoint, Outlook, J&J systems)
- Customer focus for internal customers. Ability to develop close relationships with colleagues at all levels.
- Integrity and Credo-based Actions - The ability to build trust; tells the truth; initiates transparency into problems; demonstrates genuine caring for people.
- Collaboration and Teaming
- The ability to work well across functions and groups and to build effective teams.
- The willingness to put interests of enterprise above own and is solutions focused
- Positive attitude, well organized with attention to details. Has a sense of urgency

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