Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc... allowed, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)
Job Description
As part of the Thermo Fisher Scientific team, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world's toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.
DESCRIPTION
How you will make an impact:
- Manage the ISO 9001 internal audit programme, including auditor qualification and competency maintenance, and conduct audits in line with the approved schedule
- Liaise with customers regarding regulatory, compliance and technical issues
- Coordinate and lead external audit activites with customers
- Ensure technical files are up to date and in full compliance with IVDR (EU) 2017/746
- Liaise with Certification & Notified Bodies regarding ISO certification issues and CE marking of product
- Liaise with the MHRA and other Competent Authorities regarding regulatory compliance to IVDR
- Manage the customer complaints process, ensuring effective root cause analysis has been carried out and that corrective action plans are produced, are effective and completed within agreed timescales
- Produce customer complaint reports and ensure customer complaint response times comply with company targets
- Train relevant personnel in root cause analysis as required
- Analyse complaint data and monitor trends to highlight further areas of improvement
- Produce monthly complaint KPI reports
- Support the ongoing maintenance and effective operation of electronic quality systems, ensuring systems remain compliant, current, and fit for purpose.
- Provide functional oversight of the Batch Release Team, supporting workload coordination, prioritisation and activities to ensure timely and compliant batch release.
REQUIREMENTS
Minimum Requirements/Qualifications:
- Honours degree in a science or engineering subject
- Fully conversant in Microsoft Word & Excel (especially Pivot tables)
- Six Sigma Green or Black Belt certification preferred
- Previous experience in blow/injection moulding and extrusion would be advantageous
- Formal qualifications in quality e.g. CQI Diploma, A11, A12 or MSc preferred
- Full member or Chartered member status of the Chartered Quality Institute would be advantageous
- Proven experience of successfully managing internal audit programmes
- Lead QMS auditor qualification would be advantageous
- Background or experience working within ISO13485 Quality Management Systems would be advantageous
Non-Negotiable Hiring Criteria:
- Proven experience of dealing with Notified Bodies and the MHRA regarding regulatory compliance issues for IVDR
- Formal training, proven experience and success in the use of quality tools such as RCA, 5Y, 8D, C&E, Pareto, Control Charts etc.
- Previous experience in a regulatory or compliance role in the medical device/IVD sector
