Principal Quality Associate

2 months ago

North Duffield, United Kingdom GBUK Ltd Full time

**Job description**

Due to continued companywide changes, we are looking for an enthusiastic person to join our expanding Compliance Team.

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 supply the NHS as well as export to over 40 countries worldwide.

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 Principal 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**:

- Assist the Quality Manager in creating processes, and ensuring systems are efficient and compliant with applicable standards/regulations.
- Represent the Quality team in the review of change controls.
- Oversee the logging, investigation, and documentation of all non-conformities, ensuring appropriate action is taken and completed within appropriate timescales including:

- Corrective and Preventative Action Reports (CAPA)
- Non-Conformity Reports (NC)
- Oversee the logging, investigation, and documentation of all product complaints, including:

- Recall handling
- Regulatory reporting
- Chair Quality Review Meeting, including undertaking QA analysis of all prepared data whilst escalating any trends to a CAPA. Assist with preparation for management review.
- Take part in internal and external audits.
- Assist the Quality Manager to coordinate work for the team. Deputise for the Quality Manager in their absence.

**Essential Requirements**:

- Worked within a Quality environment, preferably in the Medical Device Industry.
- Experience of working to a recognised QMS; ISO 13485, or ISO 9001 as a minimum.
- Qualification in or experience of Internal Auditing, preferably at Lead Auditor level.
- Experience of CAPA/Complaints and Root Cause Analysis.
- Knowledge of and experience in writing processes compliant with standards.

**Desirable Requirements**:

- Experience or knowledge of the MDR.
- Knowledge or experience of reporting incidents to the FDA

**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
- Problem Solver
- Able to project manage multiple tasks
- Organised working style with the proven ability to meet deadlines
- Eye for detail.
- High level of computer literacy

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**: £36,0000 - £42,000.00 per year

**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

**Salary**: £36,000.00-£42,000.00 per year

**Benefits**:

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

Schedule:

- Day shift
- Monday to Friday
- No weekends

Ability to commute/relocate:

- North Duffield, YO8 5DD: reliably commute or plan to relocate before starting work (required)

**Experience**:

- Quality: 1 year (preferred)

Licence/Certification:

- Driving Licence (preferred)

Work authorisation:

- United Kingdom (preferred)

Work Location: In person

Reference ID: GBUK/Q2

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