QMS Specialist

As a QMS Specialist the employee will be responsible for assisting the Senior QMS Manager in ensuring that the Rayner QMS is fit for purpose and is suitable for all Rayner divisions with particular focus on the European based sites.

Please note that this role is hybrid (3 days on-site, 2 days WFH) at our Rayner Biomaterials HQ in Sousel, Portugal.

What You'll Be Doing:

• Assist in the maintenance, administration, and development of the Internal Audit System
• Assist in the maintenance and development (i.e., Training) of the Internal Audit Team.
• Assist in the maintenance and administration of External Audits as required.
• Undertake maintenance, administration, and development of the QMS elements of the onboarding and offboarding System as per HR and the Quality requirements.
• Assist in the maintenance, administration, and development of the e-QMS platform (IQMS from Ideagen) platform.
• Assist in the maintenance, administration, and execution of the Change Control System
• Assist in the maintenance, administration, and execution of the Planned Deviation System
• Assist in the process development to streamline and simplify Quality Management and associated systems.
• Assist in the identification, management, and completion of Corrective and Preventive Actions with a commitment to continuous improvement.
• Undertake the archiving of company material, ensuring an efficient system which is easily accessed and utilised in line with the relevant procedures.
• Assist the Senior QMS Manager in establishing and maintaining standard operating procedures for document development, management, and control.
• This includes all documents associated with Quality Systems, such as the Quality Manual, Corporate and facility requirements, manufacturing and quality specifications, Device Master Records, and documentation related to Quality System training.
• Support other teams in the creation and maintenance of Quality Management or equivalent System related procedures, records, and work instructions, as required.

What Experience & Skills You Will Need:

Essential

• Experience working with Quality Management Systems
• Business level English (B2 and above)
• Computer literate, working knowledge of Microsoft office products e.g., Excel, Word, etc.

Desirable

• Experience working in Quality Assurance or Regulatory Affairs
• Experience of working with electronic QMS e.g., Ideagen “Quality Management Platform”
• Experience in Auditing (External and Internal)
• Knowledge of ISO 13485
• Knowledge of CFR820
• Advanced Excel, Word, and Adobe skills

What We Can Offer You:

• Comprehensive benefits package
• Global appreciation platform to recognise colleagues around the globe
• Fantastic opportunity to work with highly talented teams and individuals and grow with the business
• Being part of an organisation you can be proud to work for changing the lives of millions of people!