Quality Assurance Officer

2 weeks ago


Washington, United Kingdom Theo James Recruitment Ltd Full time

Shift:
Monday - Thursday inclusive 8.00 am - 4.30 pm

Friday 8.00 am - 3.30 pm/Flexitime

**Benefits**:

- Pension 5% Contribution EE and ER
- Pension salary sacrifice scheme (NI savings)
- Health shield after probation (Cash Health Scheme)
- Death in Service Scheme (twice annual salary benefit)
- Support NPD regarding FMEAs, and other aspects of risk management where required.
- Support change controls, QMS records (such as CAPA records), and documentation control in line with current procedures
- Ensure effective implementation of CAPAs in response to non-conformities raised from several input functions such as internal complaints, supplier CAPA, etc.
- Review batch history records and validation documentation where required.
- In co-operation with the buyer, ensuring vendors are controlled and monitored. Vendor audits and liaisons with vendors to ensure product quality is maintained.
- Reactive and proactive investigation of products and processes regarding quality issues raised post-market.
- Implement and deliver aspects of training relating to Quality Assurance and QMS across the site where required.
- Assist with the maintenance and implementation of the Customer Complaint System. Work with colleagues to identify the root cause and oversee the implementation of any corrective actions. Support submission of regulatory documentation, as required.
- Support the Product Complaint System to ensure that reports of product non-conformity are recorded, investigated, and appropriate preventative actions determined implemented, and monitored to prevent reoccurrence.
- Carry out internal audits to a pre-determined audit schedule to ensure compliance with the scope of certification of Quality Management System and Regulatory Requirements.
- Assist where required during External Audits
- Undertake training and development as required.
- Provide a positive influence in the implementation of new and alternative practices or systems.
- Demonstrate good use of initiative and support the department in achieving KPIs and objectives.
- The job entails interaction between departments within Rocket Medical: it is essential that the job holder has good interpersonal and communication skills.
- It is essential that the jobholder exhibits a high level of conscientiousness and accuracy in all tasks or duties.
- Good organization skills and methodical approach to work
- The job holder must maintain and uphold company values.

**Skills & experience**

Hold a degree qualification or have suitable evidence of 2 years of vocational experience within a similar role.

Working knowledge of 13485 & 93/42/EEC

Auditing background and can demonstrate lead auditor principles?

Excellent verbal and written communication within all levels of the business.

Able to motivate and provide regulatory guidance.

Experience working with regulatory/quality software systems.

**Why Should You Apply?**
- Theo James Recruitment specializes in Manufacturing & Engineering recruitment across the following disciplines._

Senior Appointments

Leadership and Management

Supply Chain/Logistics

Design - Engineer, Management

Project Engineering, Management

Production / Process Engineering

Maintenance - Technician, Engineer, Management

Quality - Engineering, Management

Health, Safety & Environmental

HR & Finance

Sales & Business Administration

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

**Salary**: £30,000.00-£34,500.00 per year

**Benefits**:

- Company pension
- Flexitime
- Free parking
- On-site parking

Schedule:

- Day shift
- Flexitime
- Monday to Friday

Ability to commute/relocate:

- Washington, Tyne and Wear: reliably commute or plan to relocate before starting work (required)

Work Location: In person

Reference ID: 40130



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