Supervisor, QA (Quality Systems Engineer)

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