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- Tasks: Join a dynamic team to ensure top-notch quality in products and processes.
- Company: Thermo Fisher Scientific is a leader in the pharmaceutical and biotechnology sectors.
- Benefits: Enjoy a standard Monday to Friday schedule with opportunities for professional growth.
- Why this job: Make a real impact on product quality while collaborating with diverse teams.
- Qualifications: A degree in a relevant field and experience in quality assurance are essential.
- Other info: Be part of a supportive environment that values innovation and teamwork.
The predicted salary is between 30000 - 42000 £ per year.
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Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Office
Job Title: Quality Engineer
Location: Inchinnan
Position Objective:
We are recruiting for a Quality Engineer to join our small team onsite in Inchinnan. The role will establish and maintain outstanding Quality Systems that align with ISO13485 and FDA 21CFR Part 820. Assure compliance with both internal and external specifications and standards. Actively lead data collection, trend analysis, investigations, and improvements to processes, products, and systems.
Essential Functions:
- Collaborate closely with Production, Technical, and Manufacturing Engineering teams to resolve quality-related issues from customer complaints/concerns and internal incidents. Facilitate investigations and resolution of related quality issues.
- Partner with technical support and manufacturing to build and modify methods and procedures, ensuring that appropriate processes, products, materials, and manufacturing equipment meet stringent standards.
- Aim to improve efficiency in procedures and processes without compromising quality. Identify and implement improvement opportunities across the operational facility.
- Conduct statistical analysis to identify trends, investigate root causes, and lead corrective actions for processes and products.
- Maintain a detailed knowledge of Regulatory and Quality System requirements (ISO13485/FDA CFR).
- Apply the Trackwise system for handling non-conformances, deviations, and Corrective and Preventative Actions (CAPA).
- Apply the Agile system for change controls and provide training, support, and facilitate the change control process within operations.
- Participate actively on the Internal Quality Audit team.
- Ensure compliance with both in-house and external specifications and standards, such as GMPs and ISO regulations, and approve dispositions for non-conformances on raw materials and finished goods.
- Provide training and support to other QA staff as required.
- Perform independently with minimal direction, exercising considerable latitude in resolving technical objectives and solutions to complex problems.
- May perform additional related duties as required and assigned.
Education:
A Bachelor\’s or Master\’s degree in chemistry, biochemistry, microbiology, engineering, or a related field is required.
Experience:
- Related quality experience and demonstrated knowledge of compliance, quality, and scientific principles is required.
- Proficiency in Six Sigma tools and methodology is essential.
- Must have strong communication skills, work well in teams, and interact across all levels.
- Must be a self-starter who can take general concepts and direction and produce outstanding results.
- Additionally, must function effectively and efficiently in a global, multi-site organisation.
Contacts:
Will collaborate extensively with all other departments on matters relating to quality and service to uphold the company\’s dedication to customer happiness. This involves working with people at all levels within the organisation, as well as external customers and regulatory bodies.
Seniority level
-
Seniority level
Not Applicable
Employment type
-
Employment type
Full-time
Job function
-
Job function
Quality Assurance, Product Management, and Engineering
-
Industries
Pharmaceutical Manufacturing and Biotechnology Research
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Quality Engineer employer: Thermo Fisher Scientific
Contact Detail:
Thermo Fisher Scientific Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Quality Engineer
✨Tip Number 1
Familiarise yourself with ISO13485 and FDA 21CFR Part 820 regulations. Understanding these standards will not only help you in the interview but also demonstrate your commitment to quality assurance.
✨Tip Number 2
Brush up on your Six Sigma knowledge and be prepared to discuss how you've applied these tools in past roles. Highlighting specific examples of process improvements can set you apart from other candidates.
✨Tip Number 3
Network with current or former employees at Thermo Fisher Scientific. They can provide valuable insights into the company culture and expectations, which can help you tailor your approach during the application process.
✨Tip Number 4
Prepare to discuss your experience with data collection and trend analysis. Being able to articulate how you've used statistical methods to drive quality improvements will showcase your analytical skills effectively.
We think you need these skills to ace Quality Engineer
Some tips for your application 🫡
Understand the Role: Read the job description thoroughly to understand the key responsibilities and requirements for the Quality Engineer position. Tailor your application to highlight how your skills and experiences align with these expectations.
Highlight Relevant Experience: Emphasise your related quality experience, particularly in compliance and quality assurance. Mention any specific projects or roles where you applied Six Sigma tools or worked with ISO13485 and FDA regulations.
Showcase Communication Skills: Since the role involves collaboration across various teams, make sure to demonstrate your strong communication skills in your CV and cover letter. Provide examples of how you've effectively worked in teams or resolved conflicts.
Tailor Your CV and Cover Letter: Customise your CV and cover letter for this specific role. Use keywords from the job description and ensure that your documents reflect your ability to meet the essential functions outlined by Thermo Fisher Scientific.
How to prepare for a job interview at Thermo Fisher Scientific
✨Know Your Standards
Familiarise yourself with ISO13485 and FDA 21CFR Part 820. Be prepared to discuss how these standards apply to quality systems and how you've ensured compliance in your previous roles.
✨Showcase Your Analytical Skills
Be ready to talk about your experience with statistical analysis and trend identification. Prepare examples of how you've used data to drive improvements in processes or products.
✨Collaboration is Key
Highlight your ability to work with cross-functional teams. Share specific instances where you resolved quality-related issues by collaborating with production, technical, or engineering teams.
✨Demonstrate Your Problem-Solving Abilities
Prepare to discuss complex problems you've faced in quality assurance and the solutions you implemented. Emphasise your self-starter attitude and how you take initiative in challenging situations.
