Logo of Huzzle

Home

Matches

Explore

Manage

Quality Specialist

image

Thermo Fisher Scientific

6d ago

  • Job
    Full-time
    Junior, Mid & Senior Level
  • Research & Development
  • Barcelona

AI generated summary

  • You need a bachelor's in Life Sciences, quality assurance experience, knowledge of relevant regulations, and strong analytical skills. Medical device experience is preferred; travel up to 20% is required.
  • You will implement quality procedures, conduct audits, analyze data, train team members, maintain QMS, and manage nonconformance and corrective actions to ensure project quality and 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 this position?

The work schedule is a 7 1/2 hour shift.

What are the environmental conditions for this role?

The environmental conditions are office-based.

What is the primary responsibility of a Quality Specialist I at Thermo Fisher Scientific?

The primary responsibility is to ensure the flawless quality of products by collaborating closely with internal teams and implementing quality assurance procedures.

Is experience in the medical device industry required for this role?

While it's preferred, proven experience in quality assurance is required, and experience in the medical device or life sciences industry will be beneficial.

What are the educational requirements for this position?

A bachelor's degree in Life Sciences or a related field, or equivalent experience is required.

Will this position require travel?

Yes, this position may require up to 20% domestic and international travel.

What are the key skills required for a Quality Specialist I?

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

What specific Quality Management System requirements should applicants be familiar with?

Applicants should be knowledgeable of Quality Management System requirements, especially regarding European regulations like 21 CFR Part 820, ISO 13485/IVDR, and ISO 9001 requirements.

Does Thermo Fisher Scientific provide accommodations for individuals with disabilities?

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

Where can candidates apply for this position?

Candidates can apply by visiting http://jobs.thermofisher.com to start their journey with Thermo Fisher Scientific Inc.

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.