Plasma Biotal Limited has been established for over 30 years. We specialise in the thermal spraying of medical-grade hydroxyapatite coatings, and manufacture hydroxyapatite and other calcium phosphate materials for a worldwide customer base. We are now looking to recruit a Quality Assurance Engineer to assist our rapidly growing powder manufacturing facilities in Tideswell and Buxton.
We are seeking a meticulous and proactive Quality Assurance Engineer to join our growing team. In this role you will play a crucial part in monitoring and verifying all quality procedures, ensuring our products and services consistently meet the highest standards of safety, legality and quality.
Your Profile:
- Experience in Quality Assurance, ideally in manufacturing or laboratory environments.
- Understanding of ISO 13485 or ISO 9001 and GMP/GDP principles.
- Proficiency in Microsoft office (Word, Excel, PowerPoint, Outlook).
- Strong attention to detail and accuracy in record keeping.
- Familiarity with quality management and document control systems.
- Reliable and conscientious.
- Excellent interpersonal and communication skills (written and verbal) with the ability to communicate at all levels.
- Certificate in internal auditing is desirable, though not essential as training can be provided.
- Strong problem-solving skills.
- Ability to manage own time and workload effectively.
- Highly motivated, proactive and team-orientated to achieve goals and make continuous improvement.
- Ability to remain focused on Quality and consistently reiterate its importance to others.
Responsibilities:
- Maintain and manage quality documents, records and controlled documents in compliance with ISO standards and company procedures.
- Perform regular internal audits and assist with external audits.
- Review FMEAs and maintain control plans/process flows and specification control.
- Lead CAPA investigations and be a point of contact for Customer quality concerns.
- Perform internal calibration and manage external calibration providers.
- Product release inspection of reports and approved signatory / stamp holder.
- Change control management.
- Pest control monitoring.
- Participate in validation report review and external document review.
- Where required, raise SCARs against suppliers and follow up to ensure effective CAPA are implemented.
- Ensure a safe and healthy working environment by following Company Health and Safety rules and hygiene practices.
- Other tasks as required to support the business
Salary:
- £23,400 - £31,200 a year.
- Job Type: Permanent, Full-time or Part-Time (Minimum 30 hours per week). Specific hours and patterns are negotiable for the right candidate.
Benefits:
- Company pension: 5% employer contribution.
- Discretionary profit related bonus.
- Annual leave entitlement: 22 days per year (Pro rota) + bank holidays. Additional 3 days after 5 years’ service. Additional 2 days after 10 years’ service.
- Birthday holiday leave.
- Free on-site parking and tea/coffee during breaks