Quality Assurance Coordinator

SGS; Remoto; EUR 50.000 - 70.000; Tempo pieno

Descrizione del lavoro

A leading global TIC company is seeking a QA Manager who will maintain the quality management system for medical devices. The role is remote and requires significant QA experience. Strong organizational and documentation skills are essential, as well as in-depth knowledge of quality management systems. Ideally, you have a degree in Biomedical Sciences and familiarity with global medical device regulations. Join a supportive and inclusive environment that values professional growth.

Servizi

Flexible schedule

Continuous learning options

Multinational environment

Benefits platform

Competenze

• Good working knowledge of quality management systems including CAPA management.
• Ability to organise own workload considering priorities.
• Experience with medical devices is a plus.

Mansioni

• Manage daily QA tasks including document maintenance.
• Support the development of combined scheme documents.
• Ensure compliance with quality management system.

Conoscenze

Quality management systems

Detail oriented

Organisational skills

MS Office tools

Fluent English

Formazione

Bachelor's degree in Biomedical Sciences or similar

Descrizione del lavoro

Overview

Main Purpose of Role: Maintenance of the NB 1639 medical device internal quality management system.

This role will report to the Quality & Regulatory Manager Business Assurance. It is remote based and we are open to candidates located everywhere across Europe, but they must hold a valid work permit for their country of residency.

Responsibilities

• Managing of daily QA tasks: Updating and maintenance of documents under the MDD MDR and IVDR scheme
• Management the IF database
• Collaboration on generic scheme documents
• Publishing of documents on the SGS website
• Bizzmine (Quality Management System); user communication and maintenance.
• Management of complaints compliance queries and appeals
• Management of continual improvement
• Management of document control and records
• Perform quality assurance check on updated quality management system documents
• Release of updated quality management system documents in Bizzmine
• Build a good working relationship with the Global Medical Device Certification / Competency / Technical and Clinical Manager(s) and other Global Medical Device Team members
• Undertake personal professional development and ensure appropriate training records are updated
• Provide technical support to all parts of the business
• Maintain a full knowledge and understanding of SGS procedures regulations guidance documents (e.g. MDCG) and external approval criteria
• Support the development and maintenance of combined scheme documents.

Qualifications & Skills

Essential :

• Good working knowledge of quality management systems including CAPA management, document control and good documentation practices (GDP)
• Detail oriented
• Strong organisational skills
• Ability to organise own workload considering priorities set by the global medical device quality manager
• Ability to adapt quickly and demonstrate flexibility
• Ability to work in a team
• Ability to write clear procedures
• Good working knowledge of the main MS office tools (Word Excel Outlook)
• Fluent written and spoken English.

A nice to have :

• Detailed understanding of global medical device regulations MDR and IVDR and medical device directive MDD
• Knowledge of accreditation standard ISO 17021-1 : 2015 ISO 13485 ISO 9001.

Experience

Essential : Significant work experience in a position with QA responsibility.

A nice to have : Experience working with medical devices

Auditing experience against recognised standards.

Qualifications

Essential : Bachelors degree (or higher) in Biomedical Sciences or similar field (e.g. pharmacy bioengineering nurse ...)

A nice to have : Medical device training on MDD MDR IVDR or ISO 13485

Medical device auditor

Performance Indicators

• Turnaround time for compliance issues / complaints / appeals
• Efficient running of QMS and release of quality management documents.

How to Apply

Please send your CV in English

Additional Information

• Why SGS — Global and very stable company world leader in the TIC (Testing Inspection and Certification) industry.
• Flexible schedule and hybrid model.
• SGS university and Campus for continuous learning options.
• Multinational environment where you will work with colleagues from multiple continents.
• Benefits platform.

Join Us: At SGS we believe in innovation collaboration and continuous improvement. We offer a supportive and inclusive work environment that encourages professional growth and personal development.

Remote Work: Yes

Employment Type: Full-time

Key Skills

Quality Assurance, FDA Regulations, Data Collection, Food Industry, ICH Q7, ISO 9001, Hospice Care, Food Processing, Quality Management, cGMP, QA / QC, HACCP

Experience

years

Vacancy

1