About the role

Aplyr's Quick Take

This role is about overseeing quality assurance processes, managing audits, and ensuring compliance with ISO standards and regulations. You'll be leading a team, analyzing customer complaints, and coordinating with various regulatory bodies. It's primarily a supervisory position with a focus on quality systems.

Good fit

Ideal candidates have a background in science or engineering, experience in quality assurance, and strong analytical skills. A Six Sigma Green Belt is required, and those who thrive in structured environments with attention to detail will do well here.

Worth noting

The job requires strict adherence to cleanroom protocols and PPE usage, which may be a downside for some. The role also involves significant interaction with regulatory bodies, which could be a unique opportunity for those interested in compliance.

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

Aplyr's read

Thermo Fisher Scientific is a powerhouse in biotechnology, attracting professionals passionate about advancing scientific research and innovation across diverse roles and regions.
Synthesized from recent postings & public sources

What's promising

•Thermo Fisher is a leader in the biotech industry, offering stability and growth potential.
•The company invests heavily in R&D, fostering innovation and cutting-edge solutions.
•Global presence provides diverse career opportunities across multiple regions and disciplines.

What to watch

•High pressure and fast-paced environment may not suit everyone.
•Complex organizational structure can lead to communication challenges.
•Frequent acquisitions may result in uncertainty and change for employees.

Why Thermo Fisher

•Thermo Fisher's broad product portfolio spans laboratory equipment to clinical diagnostics.
•The company plays a crucial role in global scientific advancements and healthcare solutions.
•Strong focus on sustainability and corporate responsibility sets it apart in the industry.

Aplyr’s read is generated by AI from public sources. Was it useful?

About Thermo Fisher

Thermo Fisher

thermofisher.com

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Thermo Fisher Scientific is a global leader in serving science, providing a range of products and services to help researchers and scientists in laboratories and clinical settings.