DHF Quality Engineer

Pay: £37,500.00 - £48,500.00 per year

Job description:

POSITION TITLE: DHF Process Quality Engineer

REPORTS TO: QA Manager

LOCATION: First Water Ramsbury Ltd, Ramsbury

PURPOSE OF THE ROLE

The DHF Process Quality Engineer is a key member of the Quality Assurance team at First Water Ramsbury Ltd, a Gentell company. The role is responsible for supporting and maintaining an effective Quality Management System (QMS) in compliance with ISO 13485:2016, EU MDR 2017/745, UK MDR 2002 (as amended), and MDSAP requirements.

The position supports the QA Manager in ensuring that products and processes consistently meet regulatory, customer, and internal quality requirements, while driving continuous improvement across site operations.

KEY RESPONSIBILITIES

Specific responsibilities include, but are not limited to:

• Support the preparation and maintenance of DHF and Technical Files for CE marking and international registrations.
• Work cross-functionally with R&D, Quality Assurance, Regulatory Affairs, and Manufacturing teams to collect and integrate necessary documentation.
• Project manage activities simultaneously to ensure timely, compliant documents are generated to support Tech File submissions for new product launches
• Maintain document control systems, including version control, approval workflows, and archiving per company procedures.
• Review and edit technical content for accuracy, completeness, and compliance.
• Design artworks for packaging using appropriate software
• Support internal and external audits and inspections by providing required documentation and addressing any document-related findings.
• Supplier Management and perform supplier audits.
• Execute and support activities to ensure effective monitoring of supplier performance including supplier corrective actions
• Provide technical expertise regarding validations, verification and qualifications
• Assessing current products or services and identifying quality issues
• Determining performance indicators for a product or service’s quality
• Assist in the continuous improvement of documentation processes and templates to increase efficiency and ensure compliance.
• Train staff on documentation and DHF best practices as needed.
• Support External / regulatory or customer audits
• Any other activities delegated by the Quality Manager

COMPLIANCE & REGULATORY ALIGNMENT

This role directly supports compliance with:

• ISO 13485:2016 – Quality Management Systems for Medical Devices
• EU MDR 2017/745 – Medical Device Regulation
• UK MDR 2002 (as amended) – UK Medical Device Regulations
• MDSAP – Medical Device Single Audit Program
• ISO 14971:2019 – Risk Management for Medical Devices
• Applicable FDA QSR (21 CFR Part 820) principles where relevant

EEO STATEMENT

We are an Equal Employment Opportunity Employer and do not discriminate against applicants based on race, age, religion, sex, sexual orientation, gender identity, disability, or any other protected characteristic.