Senior Quality Associate

6 months ago


Selby, United Kingdom GBUK Ltd Full time

**Job description**

GBUK Group of award-winning specialist companies are experts in the provision of enteral feeding, critical care and patient handling products and technologies. Within the Group, GBUK Enteral is the UK's leading supplier of enteral feeding tubes, syringes, and gastronomy devices; GBUK Healthcare offers medical, surgical and critical care devices and GBUK Banana provides a comprehensive range of innovative safety-centred patient moving and handling systems. We are a top 20 supplier to the NHS as well as supporting patients and healthcare professionals in over 45 countries worldwide with more than 600,000 medical devices daily.

Full driving licence and your own vehicle is essential for this role as there are no public transport links to our site.

We have a fantastic opportunity become available for a Senior Quality Associate, reporting to the Quality Manager at our offices in Selby, North Yorkshire.

You will be responsible for supporting the compliance team to ensure all required certification is maintained.

**Duties will include**:

- Complete internal audits in compliance with ISO 13485, 21 CFR, MDD/MDR and UKCA regulations.
- Assist in logging, investigation, and documenting all non-conformities, ensuring appropriate action is taken and completed within appropriate timescales including:

- Corrective and Preventative Action Reports (CAPA)
- Non-Conformity Reports (NC)
- Assist in logging, investigating, and documenting all product complaints, including:

- Recall handling
- Regulatory reporting
- Assist with the preparation for the Quality Review Meeting, including preparation of trend analysis data whilst escalating any trends to a CAPA.
- Create and revise Product Specification Documentation
- Oversee and track external supplier audits and completion of actions.
- Any other duties as required

**Essential Requirements**:

- Worked within a Quality environment, within the Medical Device Industry.
- Experience of auditing to ISO 13485 preferably at Lead Auditor level.
- Experience of generating and completing CAPA/Complaints and Root Cause Analysis.

**Desirable Requirements**:

- Experience or knowledge of auditing the MDR, 21 CFR and UKCA regulations.
- Knowledge or experience of reporting incidents to competent authorities
- Experience in writing processes compliant with standards
- Experience of ISO 14001

**Key Skills and Competencies**:

- Full Driving licence and own vehicle (essential as no public transport to our site)
- Excellent interpersonal skills at all levels
- Capable of working in a team and independently
- Good organisational and leadership skills with attention to detail
- Good written and verbal communication skills
- Able to project manage multiple tasks and projects to strict deadlines

In return we provide full training for the role and ongoing support along with a full benefits package including:

- 25 days holiday plus Bank Holidays
- Company pension scheme
- Company Performance Bonus potential
- Free on-site parking
- Health Cash Plan (on completion of Probation)
- Wellness programmes
- Company Events
- Cycle to Work Scheme
- Referral Scheme
- Discounts in conjunction with linked companies

, Permanent

Schedule: Monday to Friday

**Salary**: Fro, £32,0000 per year depending on experience

**Equality**:
All qualified applicants will receive consideration for employment without regard to age, disability or medical condition; colour, ethnicity, race, citizenship, and national origin; religion; pregnancy, family status and caring responsibilities; sexual orientation; sex, gender identity, gender expression, and transgender identity; protected veteran status; size or any other basis protected by appropriate law.

**Job Types**: Full-time, Permanent

Pay: From £32,000.00 per year

**Benefits**:

- Additional leave
- Company events
- Company pension
- Cycle to work scheme
- Employee discount
- Free flu jabs
- Free parking
- Health & wellbeing programme
- On-site parking
- Sick pay

Schedule:

- Day shift
- Monday to Friday

Licence/Certification:

- Driving Licence (preferred)

Work authorisation:

- United Kingdom (preferred)

Work Location: In person

Reference ID: GBUK/Qual24.2


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