Quality Assurance Manager (Quality Systems)

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

Location: Stafford ST16 2LP, UK
Employment Type: Full Time
Work Mode: Remote
Department: QARA
Salary: £45K-55K / year
Role:
The Quality Assurance (QA) Manager will be responsible for overseeing and managing the quality management systems and processes of Strolll to ensure that our products and services consistently meet or exceed regulatory standards. This role involves building the quality team, managing internal and external audits, driving continuous improvement, and ensuring compliance with industry standards and best practices. Reporting to the VP of QARA & Cyber, you will be responsible for building a quality culture and a team in a growing organization.

Key Responsibilities:

• Quality System Management: 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 standard operating procedures (SOPs) to enhance operational efficiency.
• Team Leadership: 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.
• Internal & External Audits: Manage the internal audit programme, conduct internal audits and inspections to ensure compliance with quality and regulatory standards. Responsible for preparation, coordination and management of external audits by regulatory bodies or certification organizations. Follow-up any actions arising.
• Non-conformity, Corrective & Preventive Action: Process owner for nonconformities, and CAPA. As the process owner, lead investigations, maintain detailed records and act as the escalation point for complex issues, coordinating internally and externally to achieve timely resolution. Ensure corrective actions are implemented effectively.
• Continuous Improvement: Identify, drive and implement process improvements to meet applicable regulatory requirements, enhance product quality and customer satisfaction. Utilize tools for root cause analysis such as brainstorming, 5 why or cause-effect to address issues. Stay up to date with changes to quality standards, and best practices and implement necessary changes.
• Customer Satisfaction & Complaints: Process owner for customer complaints. Working internally and externally to maintain customer focus, and regulatory compliance.
• Training & Development: Provide mentorship and training to staff on quality processes, regulatory requirements, building a quality culture and best practices in quality management.
• Reporting & Analysis: Prepare data and inputs for management review. Analyse quality data to identify trends, and areas for improvement. Make data-driven decisions and present to senior management.
• Supplier Quality Management: Collaborate with suppliers to ensure that the quality of products and services meet company standards. Perform supplier audits as needed.

Qualifications & Experience:

• Minimum of 8 years of experience in quality management or a related field, with at least 5 years in a managerial role and ideally in the medical devices sector.
• Strong knowledge of quality management systems (QMS), including ISO 13485, FDA QSR.
• Familiarity with the design, development, and software development processes of medical devices.
• Experience with continuous improvement methodologies.
• Proficient in using quality management software and tools for data analysis and reporting.
• Strong communication and interpersonal skills to influence and interact effectively with cross-functional teams and customers.
• ISO 13485 Lead auditor

Skills & Abilities:

• Attention to detail and a high level of accuracy
• Problem-Solving: Ability to investigate issues, identify root causes, and develop effective corrective actions.
• Leadership: Proven ability to build, lead and motivate a team towards achieving organizational goals.
• Analytical Skills: Ability to analyse data and trends to drive decision-making and improvements.
• Time Management: Strong organizational skills to prioritize tasks and meet deadlines.
• Strong communication and interpersonal skills to influence and interact effectively with cross-functional teams and customers.