Albert Browne Ltd. (UK)
Quality Specialist
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Quality Specialist
Quality Specialist
Position Summary
Do you want to spend your working time making a difference in the world around you? Are you passionate about supporting the medical and pharmaceutical industries? Do you care about keeping patients and people safe? If so, then a career with Steris could be perfect for you.
About You
About Us
At STERIS, we are the technological leader in the design, production, and supply of sterilization equipment and monitoring systems.
We are currently recruiting for a Quality Specialist. This is an outstanding opportunity to join our business at a skilled professional level.
Enlisted under the Steris Group, the Quality Specialist will be responsible for supporting our fitness-for-purpose Quality Management System (QMS) to ensure adherence to ISO 13485, FDA 21 CFR Part 820/211, EU MDR, and other applicable regulatory standards.
Key Responsibility Areas:
- Document control assistance
- Site audit coordination
- Support for risk management
- Validation activities where required
Role Overview
The Quality Specialist will assist in all quality functions on-site, with key focus areas covering documentation, compliance, audits, and improvement initiatives.
Key Responsibilities
- Process document control transactions
- Review Device History Records (DHR) and support batch record release processes
- Assist with site-record retention practices
- Coordinate calibration activities, ensuring proper scheduling and accurate recordkeeping
- Support & monitor regulatory inspection preparation
- Enhance internal & external audit readiness
- Work closely with teams pre-, during, and post-audit activities
- Track and resolve audit findings before deadlines
- Support targeted Lean initiatives to continually improve processes
- Comply & assist in maintaining SAP compliance for data integrity and accessibility
Additionally, the Quality Specialist will:
- Provide oversight of document and record retention activities on-site
- Lead and/or support audit coordination
- Represent the business at key ** Slovakia-based manufacturing operations**
- Become familiar with process operators and process validation protocols
- Document processes and achieve plans within the assigned process area
- Oversee and liaise with various external partners
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Duties
- Manage administration tasks (e.g. compliance documentation, audit records) with at least 3 years of experience
- Execute document control transactions with accuracy
- Maintain familiarity with and act on QMS best practices
- Coordinate cloud-based document storage controls within established procedures
- Contribute flexibly to other duties as assigned
Supporting Relationships
- Lean Process Improvement Group (including internal audits and training)
- Regulatory Affairs (for compliance documentation)
- Mechanical/Production teams (for process validation feedback)
- Health & Safety officers (to identify and mitigate risks)
Experience & Qualifications
Minimum Requirements:
- 3+ years of experience in quality assurance, quality control, regulatory compliance, or document control
- Strong familiarity with document control systems for medical devices or pharmaceutical applications
- Experience with QMS standards including ISO 13485, FDA Part 820, and EU MDR (Medical Device Regulation)
For excelling in this role, we require the following competencies:
- Teamwork: Collaborate effectively with cross-functional teams
- Results-Oriented Mindset:
- Meet deadlines and maintain rigorous attention to detail
- Analyse technical issues and make data-driven decisions
- Adapts quickly to changing priorities and advancing expectations
- Communication: Ability to create clear and profitable written communications
- Provide accurate updates to stakeholders along key decision paths
- PC Skills: Proficient in common business software, including Excel and Word
- Additional Excel proficiency (e.g. data sorting and formula creation) is beneficial
Benefits of Joining Steris
- Globally respected employer with commitment to healthcare innovation
- Full complement of standard employment benefits in line with industry standards
- Opportunities to advance professionally within a global firm
- Integration with a collaborative, results-driven community committed to worldwide health and safety
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Quality Policy Statement
STERIS pledges our undivided commitment to maintaining quality across all products, processes, and services. We strive for continuous development and believe in upholding these standards:
- Committing to comply with customer and applicable regulatory requirements
- Professional ethics and integrity in everything we do
- Educating and engaging our teams to cultivate a culture of quality
Supporting Our Commitment
Our Quality Specialist role supports this by:
- Aligning with QMS and regulatory systems (ISO, FDA, EU MDR)
- Ensuring documentation is complete, traceable, and maintained per standards
- Driving improvements to enhance efficiency and reduce defects across processes
Equal Opportunities Policy
STERIS operates a policy of non-discrimination and equal opportunity employment, ensuring fair consideration for all applicants and employees.
We provide job opportunities and career advancement based solely on qualifications, skills, abilities, and achievement without regard for protected characteristics, including:
- Age
- Disability
- Gender (including transgender/gender reassignment)
- Marital or civil partnership status
- Pregnancy and maternity status
- Race, ethnicity, national origin
- Religion, faith or belief
- Sex (gender)
- Sexual orientation
Our intention is to select the best candidate for each position, and we comply fully with relevant UK employment laws.
Steris vision: WE HELP OUR CUSTOMERS CREATE A HEALTHIER AND SAFER WORLD by delivering groundbreaking healthcare and life sciences products.
For more information, visit www.steris.com.
Note: Steris is an Equal Opportunity Employer.
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