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Product and Process Lifecycle Specialist

4 months ago

Sheffield, United Kingdom Stirling Q&R Ltd Full time

**About the Client**

Our client, a leader in manufacturing operations, is dedicated to upholding the highest standards of quality and efficiency. Situated in the dynamic city of Sheffield, their Regulatory Affairs and Quality Assurance (RAQA) department is renowned for its commitment to innovation in enhancing product quality and operational efficiency.

**The Role**

**Background/Experience**

**Essential Duties and Responsibilities**:

- Conducting QA reviews of design transfer.
- Establishing effective validation and validation planning activities.
- Identifying and validating processes according to established validation, design control, and regulatory submission plans.
- Establishing and maintaining effective product and process control plans and Failure Mode Effects Analysis (FMEA) through change control.
- Implementing effective Statistical Process Control (SPC) mechanisms where appropriate.
- Providing appropriate training as a result of validation, control planning, and FMEAs.
- Establishing product and process capability reporting and improvement plans.
- Reviewing submission, Nonconformance (NCP), and Corrective and Preventive Action (CAPA) reports for evidence of recurring product or process quality issues and establishing effective improvement plans.
- Reviewing significant product or process change submissions.
- Liaising with customers and suppliers on quality engineering activities.
- Reporting on product and process performance Key Performance Indicators (KPIs).

**Qualifications**:

- Advanced degree or equivalent experience in a related field.
- Demonstrated at least 2-4 years' track record in a similar role, with extensive experience in quality management systems.
- Strong analytical skills and proficiency in data management and reporting.
- Excellent communication skills with fluency in English.

**Application Process**

If you are driven by quality, excel in a fast-paced environment, and seek an opportunity to make a significant impact, we encourage you to apply.

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

Pay: £30,000.00-£45,000.00 per year

**Benefits**:

- Company pension
- Free parking
- On-site parking

Schedule:

- Monday to Friday

Supplemental pay types:

- Bonus scheme

Ability to commute/relocate:

- Sheffield, South Yorkshire: reliably commute or plan to relocate before starting work (preferred)

**Experience**:

- Quality Assurance: 2 years (preferred)
- Medical Device/ IVD: 2 years (preferred)

Work Location: In person