Quality Assurance Specialist
Location: Heywood
Salary: According to experience
The Role
- Continued regulatory compliance to ISO13485 and support of Technical Documentation under (EU)2017/745 and (EU)2017/746 to maintain device compliance.
- Maintain and improve the company's Electronic Documentation Management System (EDMS) by progressing, reviewing and updating quality procedures, risk assessments and work instructions.
- Serve as key contact for quality/compliance while hosting external regulatory and accreditation bodies.
- Coordinate and manage the internal/process audit programme to drive improvement assisted alongside external consultancy.
- Manage document control processes and quality documentation through the EDMS.
- Monitor and investigate customer complaints and non‑conformities along with CAPA/root cause activities.
- Track audit findings and identify gaps within existing quality systems and implement improvements ensuring agreed actions are completed in a timely manner by stakeholders.
- Enhance compliance with ISO13485, ISO9001 and Medical Device requirements using initiative.
- Approve product literature and artwork to ensure they meet regulatory requirements.
Essential Qualifications
- Previous experience in Quality Assurance or managing a QMS within a regulated environment.
- Experience managing CAPAs, complaints and non-conformities.
- Strong documentation and procedural writing skills.
- ISO13485 experience within a Medical Device environment.
- Experience with internal auditing.
Additional Information
This is a documentation, compliance and quality systems role with some external travel. Hybrid working will be considered after a probationary period. Laboratory, inspection, and testing experience will only be considered where significant involvement within the Quality System/documentation can be demonstrated.
Quality Assurance Specialist in Middleton employer: East Lancashire Services
Join a dynamic team where your customer service skills will shine in a supportive and fast-paced environment. Our company values its employees by offering competitive salaries, opportunities for professional growth, and a culture that prioritises teamwork and customer satisfaction. Located in a thriving area, we provide a unique chance to engage with a diverse clientele while developing your career in the manufacturing sector.
