QA/RA Manager Medical Devices
QA/RA Manager Medical Devices
Location: Skipton
Type: Permanent
Salary: GBP45,000 - GBP50,000
Additional Benefits: 5% pension contribution, 25 days hol with 1 day increase per year up to 30 days plus bank hols, Private health insurance and cash back scheme.
Hours: 9am - 5pm Monday - Friday
Our client is an established innovative manufacturer of medical devices and is looking to bring in an experienced manager. With huge plans for the next 6 years and new products being developed; the successful candidate will have a team built around them and given the autonomy to strive.
Key Responsibilities
Manages and reviews quality systems processes and serves to improve awareness, visibility, and communication on quality initiatives to support assigned quality goals and priorities.
Accountable for all Quality and regulatory requirements for the business
Accountability for monitoring and maintenance of existing processes
Accountable for internal and external audits
Accountable creating and maintaining internal audit schedules and records including tracking CAPA activities as required
Accountable for the execution of Notified Body audits and track progress of responses
Accountable for investigating quality issues and interact with products suppliers regarding these
Review and investigate customer complaints, determine product failure root causes and evaluate risk of failures
Ensure that the quality system is understood and applied throughout the organisation on all levels by personnel concerned
Authorising product release to stock and completion of relevant records upon receipt
Accountable for the maintenance and generation of technical files, test reports of product conformity according to MDD and MDR.
Leads and co-ordinates regulatory activities to support assigned projects.
Ensures effective co-ordination and implementation of regulatory activities in support of product development, registration, lifecycle management and maintenance in the region.
Ensures effective planning and tracking of activities.
Ensures effective co-ordination of the review and approval of product-related packaging as required, to ensure regulatory compliance.
Ensures that budgets and forecasts are developed and actuals managed in line with corporate requirements.
Clearly defines and communicates regulatory strategy in support of new product registration, in line with commercial objectives.
Ensures that teams and functional groups are provided with clear, constructive regulatory advice and intelligence to assist planning and issue resolution during product development, registration, lifecycle management and maintenance.
Develops proposals for initiatives and implements, as required.
The Person:
You will already have experience in both ISO 13485 and medical device regulations (MDD and MDR) as well as:
Proficiency in quality systems (ISO 13485), associated documentation
Proficient medical device industry and medical device regulations ((MDD and MDR)
Bachelor's degree in a related field
Minimum 5 years' experience working in Quality and Regulatory roles within Medical devices.
Important Information: We endeavour to process your personal data in a fair and transparent manner. In applying for this role, Russell Taylor will be acting within your interest and will contact you in relation to the role, either by email, phone or text message. For more information see our Privacy Policy h t t p s : / / w w w . r u s s e l l - t a y l o r . c o . u k / p r i v a c y - p o l i c y on our website. It is important you are aware of your individual rights and the provisions the company has put in place to protect your data. If you would like further information on the policy or the GDPR please contact us on h u s s e l l - t a y l o r . c o . u k
Location: Skipton
Type: Permanent
Salary: GBP45,000 - GBP50,000
Additional Benefits: 5% pension contribution, 25 days hol with 1 day increase per year up to 30 days plus bank hols, Private health insurance and cash back scheme.
Hours: 9am - 5pm Monday - Friday
Our client is an established innovative manufacturer of medical devices and is looking to bring in an experienced manager. With huge plans for the next 6 years and new products being developed; the successful candidate will have a team built around them and given the autonomy to strive.
Key Responsibilities
Manages and reviews quality systems processes and serves to improve awareness, visibility, and communication on quality initiatives to support assigned quality goals and priorities.
Accountable for all Quality and regulatory requirements for the business
Accountability for monitoring and maintenance of existing processes
Accountable for internal and external audits
Accountable creating and maintaining internal audit schedules and records including tracking CAPA activities as required
Accountable for the execution of Notified Body audits and track progress of responses
Accountable for investigating quality issues and interact with products suppliers regarding these
Review and investigate customer complaints, determine product failure root causes and evaluate risk of failures
Ensure that the quality system is understood and applied throughout the organisation on all levels by personnel concerned
Authorising product release to stock and completion of relevant records upon receipt
Accountable for the maintenance and generation of technical files, test reports of product conformity according to MDD and MDR.
Leads and co-ordinates regulatory activities to support assigned projects.
Ensures effective co-ordination and implementation of regulatory activities in support of product development, registration, lifecycle management and maintenance in the region.
Ensures effective planning and tracking of activities.
Ensures effective co-ordination of the review and approval of product-related packaging as required, to ensure regulatory compliance.
Ensures that budgets and forecasts are developed and actuals managed in line with corporate requirements.
Clearly defines and communicates regulatory strategy in support of new product registration, in line with commercial objectives.
Ensures that teams and functional groups are provided with clear, constructive regulatory advice and intelligence to assist planning and issue resolution during product development, registration, lifecycle management and maintenance.
Develops proposals for initiatives and implements, as required.
The Person:
You will already have experience in both ISO 13485 and medical device regulations (MDD and MDR) as well as:
Proficiency in quality systems (ISO 13485), associated documentation
Proficient medical device industry and medical device regulations ((MDD and MDR)
Bachelor's degree in a related field
Minimum 5 years' experience working in Quality and Regulatory roles within Medical devices.
Important Information: We endeavour to process your personal data in a fair and transparent manner. In applying for this role, Russell Taylor will be acting within your interest and will contact you in relation to the role, either by email, phone or text message. For more information see our Privacy Policy h t t p s : / / w w w . r u s s e l l - t a y l o r . c o . u k / p r i v a c y - p o l i c y on our website. It is important you are aware of your individual rights and the provisions the company has put in place to protect your data. If you would like further information on the policy or the GDPR please contact us on h u s s e l l - t a y l o r . c o . u k