Senior QA & Compliance Leader - Medical Devices (Remote)

Strolll Limited; Stafford; Remote; GBP 45,000 - 55,000; Full time

Job summary

Strolll Limited in Stafford is seeking a Quality Assurance Manager to oversee the quality management systems and ensure our products and services consistently meet regulatory standards. You will build the quality team, manage internal and external audits, drive continuous improvement and ensure compliance with industry standards.

Reporting to the VP of QARA & Cyber, you will lead the creation of a quality culture, grow the team, and coordinate CAPA, training, and data-driven decision making

Qualifications

• 8+ years in quality management with 5+ years in a managerial role, ideally in the medical devices sector.
• Strong knowledge of quality management systems (QMS), including ISO 13485, FDA QSR.
• Experience with design, development, and software development processes of medical devices.
• Proficient in using quality management software and tools for data analysis and reporting.

Responsibilities

• Develop, implement, and maintain the company’s electronic quality management system (eQMS) to ensure compliance with ISO 13485 and other applicable standards. Design and document workflows and SOPs to enhance operational efficiency.
• Lead, mentor, build and manage a team of quality assurance experts, and internal auditors. Foster an open culture for continuous improvement and quality excellence within the team.
• Manage the internal audit programme, conduct internal audits and inspections to ensure compliance with quality and regulatory standards. Coordinate external audits by regulatory bodies or certification bodies. Follow-up actions.
• Process owner for nonconformities and CAPA. Lead investigations and coordinate timely resolution.
• Identify and implement process improvements to meet regulatory requirements and enhance product quality.
• Process owner for customer complaints and regulatory compliance across the organization.
• Provide mentorship and training on quality processes and regulatory requirements.
• Prepare data and inputs for management review; analyze quality data to identify trends and improvements.
• Collaborate with suppliers to ensure quality standards and perform supplier audits as needed.

Skills

Leadership

Quality management

Auditing

Regulatory knowledge

Data analysis

Communication

Problem-solving

Time management

Cross-functional collaboration

Attention to detail

Tools

Quality management software

Job description

Strolll Limited in Stafford is seeking a Quality Assurance Manager to oversee the quality management systems and ensure our products and services consistently meet regulatory standards. You will build the quality team, manage internal and external audits, drive continuous improvement and ensure compliance with industry standards.

Reporting to the VP of QARA & Cyber, you will lead the creation of a quality culture, grow the team, and coordinate CAPA, training, and data-driven decision making