Quality and Compliance Associate

2 weeks ago

Bristol, United Kingdom OKKO Health Full time

# Job Title: Quality and Compliance Associate
Location: UK / Remote with occasional travel to Bristol (our HQ) or London

Salary Range**:£25,000 - £30,000

About Us:
OKKO Health is at the forefront of developing innovative medical software solutions, improving patient care through cutting-edge technology. As a dedicated Software as a Medical Device (SaMD) company, we are committed to maintaining the highest standards of quality and compliance in all aspects of our operations. We are looking for a motivated Quality and Compliance Associate to join our team and help us continue to meet and exceed regulatory standards.

**Job Description**:
The Quality and Compliance Associate will play a critical role in ensuring that our products and processes adhere to regulatory requirements and company policies and procedures. This individual will support the management and maintenance of our Quality Management System (QMS), Information Security Management System (ISMS), and Data Protection Management System (DPMS). They will use our Action Tracker in Jira to manage and implement audits, corrective and preventive actions (CAPAs), customer complaints and feedback, nonconformances and information security events. They will be responsible for preparing for audits and responding to audit findings, overseeing management reviews and ensuring compliance with data protection laws.

Key Responsibilities:

- Support audit preparation and manage responses, implementing corrective action plans.
- Oversee document control and maintenance for QMS, ISMS, and DPMS.
- Assist in creating, maintaining, and overseeing policies for ISO 13485, 9001, 14971, and other regulations.
- Utilise Jira Action Tracker to manage CAPAs, customer complaints, feedback, nonconformance, information security events, and design control processes.
- Support the setting and monitoring of QMS/ISMS/DPMS objectives and KPIs.
- Support the wider team in activities such as facilitating management review meetings, actioning Data Subject Access Requests (DSARs), risk management, updating data retention policies and change management.
- Drive continual improvement, work on process improvement initiatives, and support training activities.
- Maintain awareness of industry standards and regulatory requirements.
- Assist with quality and compliance communications internally and externally.

Qualifications:

- Proven experience in quality management, audit preparation/response, and document control.
- Familiarity with ISO 13485, 14971, 27001, 9001, GDPR, and relevant standards in SaMD.
- Understanding of the software development lifecycle.
- Demonstrated ability to develop initiatives and foster collaborations across all organisational levels.
- Strong organisational and project management skills.
- Excellent communication skills, both verbal and written.
- Proficient in Jira or other quality management software.
- Proficient in Google Suite (Google Docs, Sheets, Slides, Drive etc.) or the Microsoft equivalent
- Detail-oriented with a strong analytical mindset.
- Experience in pharma/biotech/medtech environments preferred.

We Offer:

- Competitive salary and benefits package.
- Opportunity to contribute to a dynamic and innovative healthcare team.
- Professional growth and development opportunities.
- Flexible working hours and remote work options.

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