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6 months ago
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Senior Quality Engineer


Thermo Fisher Scientific
Location: Newport
Job type: Permanent
Sector: Manufacturing
Category: Quality Engineering Jobs
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Job ID : 69256BR

Location : United Kingdom - Newport

Job Description

Division Specific Information

The Laboratory Products Group (LPD) unites deep scientific expertise, a collaborative culture and rich resources to deliver the lab equipment and consumables that our customers need to achieve their scientific goals – quickly, reliably and safely. Our smart lab solutions make it faster and easier for our customers to focus on what matters most – delivering answers and innovations that save and improve lives.
Our laboratory equipment products are used primarily by pharmaceutical companies for drug discovery and development and by biotechnology companies and universities for life science research to advance the prevention and cure of diseases and enhance quality of life. Our offering consists of equipment, accessories, and services for sample preparation, storage and protection, and analysis.
Our laboratory consumables products include plastics, glass, and related equipment that customers use every day to support their scientific research, drug discovery and development, quality and process control, and clinical and basic research and development needs.

What will you do?

* Provides expert support to the Quality Manager. This position is responsible for managing the internal NCR process, provides quality support to the validation, supplier approval and supplier complaints processes
* Responsible for the management of the internal NCR process. Ensure that effective root cause analysis has been carried out and that corrective action plans are produced, are effective and completed within the agreed timescales.
* Train relevant personnel in root cause analysis as required.
* Analyse NCR data and monitor trends to highlight further areas of improvement.
* Work closely with the engineering team to ensure all validations are carried out to the required standard.
* Review all validation protocols and reports to ensure suitability.
* Manage the rework process to ensure that any rework is identified and completed in a timely manner.
* Produce and maintain the Master Validation Plan for all products.
* Collaborate with the purchasing team to ensure new suppliers are reviewed and approved.
* Carry out supplier audits as required.
* Manage the supplier complaints process to ensure all supplier issues are recorded, SCAR raised and that supplier corrective actions are reviewed for their effectiveness.
* Ensure specifications, drawings, technical data sheets in place and maintained for all raw materials and components.
* Carry out internal audits as per the internal audit schedule.
* Produce monthly NCR KPI reports.

Who we are looking for: experience, skills & abilities
* Honours degree in a science or engineering subject.
* Fully conversant in Microsoft Word & Excel (especially Pivot tables) and Minitab.
* 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.
* Previous experience in a quality role in the medical device, IVD or pharmaceutical sectors would be advantageous
* Full member or Chartered member status of the Chartered Quality Institute would be advantageous.
* Lead QMS auditor qualification.
* Full understanding, via formal training and proven experience in the technical & quality requirements of process validation i.e. IQ/OQ/PQ, including sampling, statistical analysis, protocol and report production and review.
* Formal training and proven experience in the use of quality tools such as RCA, 5Y, 8D, C&E, Pareto, Control Charts etc

What’s in it for you:
* Competitive package
* Excellent benefits - Private healthcare, contributory pension scheme, life assurance + flexible additional benefits.
* 25 days annual holiday plus UK bank holidays
* Training, career progression and opportunities within a world leader in serving science.

About us:
As the world leader in serving science, our work is more than something that fills our days. When you’re part of Thermo Fisher Scientific, you’ll do challenging work, and be part of a team that values performance, quality and innovation. With revenues of $20 billion and the largest investment in R&D in the industry, we give our people the resources and opportunities to make significant contributions to the world.

Each one of our 65,000 extraordinary minds has a unique story to tell. It’s not just a career, it’s a chance to realise your best – professionally and personally.

Join us and contribute to our mission—enabling our customers to make the world healthier, cleaner and safer. !
Job ID : 69256BR

Location : United Kingdom - Newport

Job Description

Division Specific Information

The Laboratory Products Group (LPD) unites deep scientific expertise, a collaborative culture and rich resources to deliver the lab equipment and consumables that our customers need to achieve their scientific goals – quickly, reliably and safely. Our smart lab solutions make it faster and easier for our customers to focus on what matters most – delivering answers and innovations that save and improve lives.
Our laboratory equipment products are used primarily by pharmaceutical companies for drug discovery and development and by biotechnology companies and universities for life science research to advance the prevention and cure of diseases and enhance quality of life. Our offering consists of equipment, accessories, and services for sample preparation, storage and protection, and analysis.
Our laboratory consumables products include plastics, glass, and related equipment that customers use every day to support their scientific research, drug discovery and development, quality and process control, and clinical and basic research and development needs.

What will you do?

* Provides expert support to the Quality Manager. This position is responsible for managing the internal NCR process, provides quality support to the validation, supplier approval and supplier complaints processes
* Responsible for the management of the internal NCR process. Ensure that effective root cause analysis has been carried out and that corrective action plans are produced, are effective and completed within the agreed timescales.
* Train relevant personnel in root cause analysis as required.
* Analyse NCR data and monitor trends to highlight further areas of improvement.
* Work closely with the engineering team to ensure all validations are carried out to the required standard.
* Review all validation protocols and reports to ensure suitability.
* Manage the rework process to ensure that any rework is identified and completed in a timely manner.
* Produce and maintain the Master Validation Plan for all products.
* Collaborate with the purchasing team to ensure new suppliers are reviewed and approved.
* Carry out supplier audits as required.
* Manage the supplier complaints process to ensure all supplier issues are recorded, SCAR raised and that supplier corrective actions are reviewed for their effectiveness.
* Ensure specifications, drawings, technical data sheets in place and maintained for all raw materials and components.
* Carry out internal audits as per the internal audit schedule.
* Produce monthly NCR KPI reports.

Who we are looking for: experience, skills & abilities
* Honours degree in a science or engineering subject.
* Fully conversant in Microsoft Word & Excel (especially Pivot tables) and Minitab.
* 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.
* Previous experience in a quality role in the medical device, IVD or pharmaceutical sectors would be advantageous
* Full member or Chartered member status of the Chartered Quality Institute would be advantageous.
* Lead QMS auditor qualification.
* Full understanding, via formal training and proven experience in the technical & quality requirements of process validation i.e. IQ/OQ/PQ, including sampling, statistical analysis, protocol and report production and review.
* Formal training and proven experience in the use of quality tools such as RCA, 5Y, 8D, C&E, Pareto, Control Charts etc

What’s in it for you:
* Competitive package
* Excellent benefits - Private healthcare, contributory pension scheme, life assurance + flexible additional benefits.
* 25 days annual holiday plus UK bank holidays
* Training, career progression and opportunities within a world leader in serving science.

About us:
As the world leader in serving science, our work is more than something that fills our days. When you’re part of Thermo Fisher Scientific, you’ll do challenging work, and be part of a team that values performance, quality and innovation. With revenues of $20 billion and the largest investment in R&D in the industry, we give our people the resources and opportunities to make significant contributions to the world.

Each one of our 65,000 extraordinary minds has a unique story to tell. It’s not just a career, it’s a chance to realise your best – professionally and personally.

Join us and contribute to our mission—enabling our customers to make the world healthier, cleaner and safer. !
Apply

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