Senior Qms Specialist

2 days ago

Worthing, United Kingdom Rayner Intraocular Lenses Full time

Location- Worthing- Discipline:
- Quality Assurance- Job type:
- Permanent Full Time- Job ref:
- 007807As a Senior 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.

**What You'll Be Doing**
- Undertake maintenance, administration, and development of the Internal Audit System and 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 (Q-Pulse) platform.
- Assist in the maintenance, administration, and execution of the Change Control System and Planned Deviation System.
- Undertake 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 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 Do You Need**
- Experience working with Quality Management Systems
- Computer literate, working knowledge of Microsoft office products e.g., Excel, Word, etc.
- Experience working in Quality Assurance or Regulatory Affairs
- Experience of working with electronic QMS e.g., Ideagen “Q-Pulse 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**
- Private healthcare
- Wellbeing allowance up to £300.00 a year
- Monthly yoga sessions and quarterly massages
- Annual programme of fun events
- On site restaurant
- Enhanced maternity & paternity leave
- On site parking

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