Internal & Supplier Quality Auditor
Internal & Supplier Quality Auditor required to work within QA/RA to effectively manage, plan, schedule and perform internal and supplier quality audits across the Manufacturing Division (M-BC) and supplier base to ensure continued compliance against a range of highly regulated Markets through the MDSAP Programme. This will involve extensive offsite travel to supplier sites within the UK, Europe and global. Required to work under minimal supervision while setting day to priorities based on the changing business needs. Expert knowledge of quality engineering principles, medical device regulations with practical application to the business and QMS requirements. Key leader for managing external audits such as FDA and Notified Body. Make key decisions on internal and external audits findings and leading teams to address/resolve QMS compliance gaps. Submit detailed management reports identifying business compliance risks with proposals to resolve
- Lead and manage an internal/external audit program
- Manage the collection and analysis of output and outcomes from audits
- Lead and support 3rd party audits (MDSAP), FDA and Notified Body of the M-BC
- Define, manage and lead an internal/supplier audit programme for the quality management system and complete audits according to the plan
- Ensure actions as a consequence of audits are completed within specified timescales
- Ensure continued regulatory compliance to international regulations and standards
- Provide internal auditor training
- Ensure supplier audit file are complete including ISO certificates and other relevant documents.
- Provide and present regular detailed management reports
- Lead and Support 3rd party audits (MDSAP)
- Represent the company during external audits e.g. FDA, Notified Body
Education and Qualifications:
- Educated to a higher technical qualification in an engineering, science and/or business related subject e.g. Bachelor degree or equivalent.
- The position holder must be a trained auditor, preferably through an IRCA recognised course or equivalent to MDSAP and/or ISO 9001:2015 and ISO 13485:2016.
- Must be an excellent communicator both verbal and written. Must have expert knowledge of QMS standards/requirements and quality engineering.
- Experience of auditing and assessing to multiple standards and regulations with a particular emphasis on quality management. Able to work under minimal supervision and make decisions for work priorities.
- Extensive experience within a Quality Assurance/Regulatory Affairs role
This job was originally posted as www.jobsite.co.uk/job/959524265