Quality Assurance Manager
- Recruiter
- FLAT FEE RECRUITER
- Location
- Sheffield
- Salary
- Negotiable D.O.E
- Posted
- 07 Dec 2016
- Closes
- 04 Jan 2017
- Ref
- 4187
- Contact
- Applicant Services
- Sectors
- Manufacturing & Industrial
- Contract Type
- Permanent
- Hours
- Full Time
Quality Assurance Manager
Sheffield, South Yorkshire S9
Negotiable D.O.E
Our client is an established Sheffield based medical devices company, currently looking to recruit an experienced Quality Assurance Manager to join their team.
Position Summary
As Quality Assurance Manager your main roles and responsibilities will include an array of duties including;
• Development and maintenance of the Company’s Quality Management Systems
• Managing the Company’s transition to ISO 13485:2016
• Notified Body surveillance audits
• Internal auditing
• Ensuring Company SOP's are fit for purpose
• Responsibility for the Company’s CAPA system
• Follow up of corrective and preventative action plans, raised from internal and external NCR’s
• Compilation, consolidation and management of medical device Technical Files including both OBL and full CE Marking technical documentation
• Process Validations
• Providing regulatory advice and assistance to customers
Who are we looking for?
The successful candidate will have the required skills and experience to undertake this role, including;
• Significant Internal Audit experience is essential
• Degree in a science/technical related discipline - chemistry, bio medical, medical engineering or similar is desirable
• Ability to run a QMS company wide covering all processes
• Regulatory Affairs experiences and knowledge within the health care industry
• Knowledge of ISO 13485 is essential, whereas knowledge of Council Directive 93/42/ECC and Directive 2007/47/EC is not essential but would be preferable.
• Analytical, forensically minded and the ability to make decisions
• Good communication skills both written and verbal English are essential
If you wish to be considered for this Quality Assurance Manager role click ‘apply’. You will receive an email shortly after your application - you will need to read and respond to this to complete your application. You must be eligible to work in the UK.
Sheffield, South Yorkshire S9
Negotiable D.O.E
Our client is an established Sheffield based medical devices company, currently looking to recruit an experienced Quality Assurance Manager to join their team.
Position Summary
As Quality Assurance Manager your main roles and responsibilities will include an array of duties including;
• Development and maintenance of the Company’s Quality Management Systems
• Managing the Company’s transition to ISO 13485:2016
• Notified Body surveillance audits
• Internal auditing
• Ensuring Company SOP's are fit for purpose
• Responsibility for the Company’s CAPA system
• Follow up of corrective and preventative action plans, raised from internal and external NCR’s
• Compilation, consolidation and management of medical device Technical Files including both OBL and full CE Marking technical documentation
• Process Validations
• Providing regulatory advice and assistance to customers
Who are we looking for?
The successful candidate will have the required skills and experience to undertake this role, including;
• Significant Internal Audit experience is essential
• Degree in a science/technical related discipline - chemistry, bio medical, medical engineering or similar is desirable
• Ability to run a QMS company wide covering all processes
• Regulatory Affairs experiences and knowledge within the health care industry
• Knowledge of ISO 13485 is essential, whereas knowledge of Council Directive 93/42/ECC and Directive 2007/47/EC is not essential but would be preferable.
• Analytical, forensically minded and the ability to make decisions
• Good communication skills both written and verbal English are essential
If you wish to be considered for this Quality Assurance Manager role click ‘apply’. You will receive an email shortly after your application - you will need to read and respond to this to complete your application. You must be eligible to work in the UK.