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Quality Assurance Technician

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Straumann Group

18d ago

  • Job
    Full-time
    Mid & Senior Level
  • Madrid

AI generated summary

  • You need a technician diploma, QA experience in medical devices, knowledge of ISO 13485, EDMS, and SAP. Must be reliable, proactive, and fluent in English; German is a plus.
  • You will inspect quality certificates, manage non-conformities, perform root cause analyses, write reports, maintain documents, follow up on audits, and manage SharePoint permissions.

Requirements

  • Education
  • Technician diploma, professional education, or equivalent title. Advanced graduate studies/degrees are a plus.
  • Experience
  • Previous experience in quality management within the medical devices/pharmaceutical industry, in particular NCR & CAPA processing, supplier controls and product release processes (incl. DHR review possibly)
  • Knowledge and understanding of applicable medical device regulations (ISO 13485, FDA QSR, MDR etc.)
  • Knowledge/experience working with electronic documentation management systems (EDMS), and ERP (SAP mainly).
  • Knowledge in statistical methods and good distribution practice is an asset
  • Personal Attributes
  • Reliability and diligence, also when working under pressure
  • Innovative, resourceful, and proactive disposition, committed to ensuring continuous improvement of capacity and delivering quality service
  • Ability to communicate effectively with both internal and external personnel
  • Adequate computer skills, including ability to work effectively with MS Office, in particular Excel and Word
  • Fluent (written and spoken) English, preferably also German; any additional language an asset

Responsibilities

  • Incoming goods: Quality Certificates inspection (CoC 2.1/2.2 and CoA 3.1/3.2) and product release in SAP of outsourced Straumann products including email communication with receiving sites.
  • Processing and documentation of Supply Chain related non-conformities (NCR), CAPA & SCARs
  • Root causes analyses using methods such as 5 Whys, Ishikawa, FMEA, etc.
  • Review and follow-up of corrective and preventive actions with suppliers (SCARs)
  • Writing investigation reports
  • Setup of Quality Assurance Agreements incl. follow-up
  • Maintenance of business partner information data
  • Audit execution follow-up and audit documentation acc. to GDP
  • General Condition sheet management for subsidiaries and distributors
  • Document control
  • Review document attributes in the approval workflow
  • Manage periodic review of QMS documents
  • Manage permission / add and remove users into specific user group
  • Maintain standard overview in the sharepoint list

FAQs

What is the main purpose of the Quality Assurance Technician role?

The main purpose of the Quality Assurance Technician role is to ensure the conformity and quality of products and services provided by external parties as part of the Supply Chain Compliance team.

What are the main responsibilities of this position?

Main responsibilities include inspecting quality certificates for incoming goods, processing non-conformities, performing root cause analyses, managing corrective actions with suppliers, writing investigation reports, setting up Quality Assurance Agreements, and maintaining document control.

What educational qualifications are required for this role?

A Technician diploma, professional education, or an equivalent title is required. Advanced graduate studies or degrees are considered a plus.

What experience is necessary for this position?

Previous experience in quality management within the medical devices or pharmaceutical industry is necessary, particularly in NCR & CAPA processing, supplier controls, and product release processes. Knowledge of medical device regulations and proficiency in electronic documentation management systems (EDMS) and ERP (SAP) is also required.

What personal attributes are important for a Quality Assurance Technician?

Important personal attributes include reliability and diligence, innovative and proactive disposition for continuous improvement, effective communication skills, adequate computer skills including Excel and Word, and fluency in English, preferably with knowledge in German or additional languages.

Where is the position located?

The position is located in Madrid, Spain.

What type of employment is offered for this role?

The position is offered as a Full-Time employment.

Is travel required for this role?

Yes, there is a travel percentage of 0 - 10% expected in this role.

Will I receive consideration for employment regardless of my background?

Yes, all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or disability.

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Straumann Group

Manufacturing & Electronics
Industry
5001-10,000
Employees

Mission & Purpose

The Straumann Group is a global leader in dental solutions, specialising in implantology, restorative dentistry, and digital technologies. The company develops and manufactures dental implants, instruments, prosthetics, and cutting-edge digital tools to improve patient care and treatment outcomes. Straumann's ultimate mission is to restore confidence and smiles through innovative dental solutions that improve the quality of life. Their purpose is to deliver high-quality, science-based dental products and services that enhance oral health, fostering long-term partnerships with dental professionals and improving patient care worldwide.