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Quality Specialist

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Thermo Fisher Scientific

18d ago

  • Job
    Full-time
    Junior & Mid Level
  • Science
  • Barcelona

AI generated summary

  • You must have a relevant degree, quality assurance experience, knowledge of regulations, strong analytical skills, attention to detail, and the ability to collaborate in a fast-paced environment.
  • You will implement quality assurance procedures, collaborate on improvements, conduct audits, maintain documentation, analyze data, train team members, and oversee the Quality Management System compliance.

Requirements

  • - Bachelor's degree in Life Sciences or a related field, or equivalent experience
  • - Proven experience in quality assurance
  • - Knowledge of Quality Management System requirements, especially with regard to European regulations (21 CFR Part 820, ISO13485/ IVDR and ISO9001 requirements)
  • - Experience in medical device industry/Life Sciences industry experience preferred
  • - This position would require up to 20% domestic and international travel
  • - Strong understanding of Quality Assurance methodologies and tools
  • - Excellent analytical and problem-solving skills
  • - Exceptional attention to detail and a commitment to delivering world-class results
  • - Ability to work collaboratively in a fast-paced, ambitious environment

Responsibilities

  • Determine and implement Quality Assurance procedures to ensure flawless execution of projects
  • Collaborate with cross-functional teams to successfully implement quality improvement initiatives
  • Conduct thorough audits and inspections to ensure compliance with industry standards and regulations
  • Develop and maintain documentation of quality processes and procedures
  • Analyze data and identify areas for improvement to optimize operational efficiency
  • Train and educate team members on quality standards and effective strategies
  • Maintain the Quality Management System (QMS) as directed by the Quality Assurance at HQ, and the support of the Technical Director. Ensures that PDX Spain and Portugal QMS conforms to customer, internal and local regulatory/legal requirements
  • Act as the Quality Management Representative / Subsidiary Quality management Representative for the company
  • Approves and monitors entries in the Nonconformance, Corrective Action/Preventive Action and training systems

FAQs

What is the work schedule for the Quality Specialist position?

The work schedule for the Quality Specialist position consists of a 7 1/2 hour shift.

What are the main responsibilities of a Quality Specialist?

A Quality Specialist is responsible for implementing Quality Assurance procedures, collaborating on quality improvement initiatives, conducting audits and inspections, maintaining documentation, analyzing data for improvements, training team members, maintaining the Quality Management System, acting as the Quality Management Representative, and monitoring entries in quality systems.

What educational background is required for this position?

A Bachelor's degree in Life Sciences or a related field, or equivalent experience, is required for this position.

Is experience in the medical device or Life Sciences industry preferred?

Yes, experience in the medical device industry or Life Sciences industry is preferred.

What are the travel requirements for this position?

This position may require up to 20% domestic and international travel.

What quality management standards should a candidate be familiar with?

Candidates should have knowledge of Quality Management System requirements, specifically regarding European regulations such as 21 CFR Part 820, ISO 13485, IVDR, and ISO 9001.

Are there any specific skills required for this role?

Yes, the role requires a strong understanding of Quality Assurance methodologies and tools, excellent analytical and problem-solving skills, exceptional attention to detail, and the ability to work collaboratively in a fast-paced environment.

Does Thermo Fisher Scientific offer accommodations for individuals with disabilities?

Yes, Thermo Fisher Scientific is committed to providing reasonable accommodations for individuals with disabilities.

How can I apply for the Quality Specialist position at Thermo Fisher Scientific?

You can apply for the Quality Specialist position by visiting http://jobs.thermofisher.com to start your application process.

Is Thermo Fisher Scientific an equal opportunity employer?

Yes, Thermo Fisher Scientific is an equal opportunity employer and values diversity in the workplace.

Thermo Fisher Scientific

The World Leader In Serving Science

Science & Healthcare
Industry
10,001+
Employees

Mission & Purpose

Thermo Fisher Scientific Inc. 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 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.