Quality Engineer

Location

Basingstoke, Hampshire | United Kingdom

Job description

Position : Quality Engineer

Location: Basingstoke

Hours: Monday - Friday (8am-4pm)

Thermo Fisher Scientific Inc. (NYSE: TMO) is the world leader in serving science, with annual revenue of approximately $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, increasing productivity in their laboratories, improving patient health through diagnostics or the development and manufacture of life-changing therapies, we are here to support them. Our global team of more than 100,000 colleagues delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon and PPD. For more information, please visit .

Position Summary:

The Quality Engineer will champion the implementation, improvement and continuation of quality assurance practices in Operations. The successful candidate will work with Operations to ensure the overall quality of manufactured product and create documentation, devise quality tests and define the criteria a test result should meet.

They play a key role in fixing issues when they arise. They will partner with Operations and is the primary point of contact for all Quality decisions affecting daily activities.

The Quality Engineer will assist Operations management in facilitating SOP management and procedural adherence, product and process failure investigations, in process controls and validation. In addition, they will evaluate and utilise design concepts to ensure quality standards are routinely met.

The individual selected for this role will act as an effective leader in promoting quality disciplines, decisions and practices and will apply sound, systematic, problem-solving methodologies in identifying, prioritising, communicating and resolving quality issues identified with consistently failing product and processes.

Key Responsibilities:

Create quality documentation and development of SOPs for the facility and products in line with industry and regulatory standards.

Proactively review and improve systems and processes to ensure maintenance of standards.

Maintain accurate quality documentation.

Work closely with Operations to ensure quality procedures and standards are followed and documentation is correctly maintained and implement any new changes or adaptations based on a quality review.

Partner with Operations leadership to establish controls and inspection points to facilitate detection, correction, and prevention of nonconforming materials, parts, assemblies, and products.

Analyse problems reported and develop improvements to overcome them

Conduct statistical analysis of manufacturing data and create reports for senior management based on quality documentation.

Provide Quality guidance to product and process failure investigations, validation protocols, validation reports and in-process controls.

Assist Operations in solving process issues and facilitate inter- department team workshops in the resolution of quality problems.

Work with Operations, R & D, Purchasing and Engineering to improve product quality while reducing material scrap and costs.

Drive quality management focus on productivity improvements throughout operations.

Serve as Quality Representative for all quality-related corrective/preventive actions within Operations.

Assure that Operation's standards align with division and departmental policies, national and international codes, and applicable safety requirements.

Analyse trends and collaborate with Operations to investigate trends, conduct root cause analysis and implement corrective actions for processes and products.

Minimum Requirements/Qualifications:

• Bachelor’s degree required in science subject area or related field with quality assurance experience in a medical device or pharmaceutical manufacturing environment.
• Strong background in process control and statistical techniques.
• Medical device, GMP, EU Regulation or ISO 13485 background.
• Proven understanding of compliance, quality and scientific principles.
• Must be a self-starter who can take general concepts and direction and produce desirable results.
• Ability to prioritise multiple tasks functions effectively in a global, multi-site organisation.

• Work effectively as a member of a cross- functional team.
• Strong comprehension of quality related tools, such as structured problem solving, FMEA (Failure Mode and Effects Analysis), SPC (Statistical Process Control), DOE (Design of Experiments) and Six Sigma/PPI.
• Strong solid understanding of various computer software, such as SAP, as well as Microsoft Word, Excel and PowerPoint.
• Experience with lean manufacturing practices.
• Knowledge of qualification / validation (process, sterilisation, cleaning, software) requirements.
• Perform independently without continual direction and exercise considerable latitude in determining technical objectives and solutions to complex problems.
• May be required to support in completion of related duties as the need arises and/or assigned.

Non-Negotiable Hiring Criteria:

• Excellent oral and written communication skills.
• Strong leadership skills with the ability to challenge, influence, and build consensus.
• Ability to work both independently and as a team member.
• Strong quality background and problem analysis and decision-making skills.

Thermo Fisher Scientific Inc. (NYSE: TMO) is the world leader in serving science, with annual revenue of approximately $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, increasing productivity in their laboratories, improving patient health through diagnostics or the development and manufacture of life-changing therapies, we are here to support them. Our global team of more than 100,000 colleagues delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon and PPD. For more information, please visit .

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