Quality Systems Analyst

Werkgever CLS Services
Plaats Leiden
Provincie Zuid-Holland
Land Nederland
Dienstverband Deeltijd (< 36 uur)
Contract Vast
Plaatsingsdatum vrijdag 10 augustus 2018

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CLS Services is a leading professional recruitment agency, specialised in the recruitment and career coaching of people with a background in chemistry & life sciences. For our client, Mentor Medical Systems, we are searching for a Quality Systems Analyst .

Company profile
A Global Leader in Aesthetic Medicine Founded in 1969, Mentor Worldwide LLC is a leading supplier of medical products for the global aesthetic medicine market. The Company develops, manufactures, and markets innovative, science-based products for aesthetics markets around the world. Headquartered in Santa Barbara, California, Mentor has manufacturing and research operations in the United States, Mauritius, and the Netherlands. Mentor has made breast implant devices for more than 20 years. Mentor's breast implants are for use in both breast augmentation and breast reconstruction and are of the highest quality, and made under strict standards of design and testing.

The Quality Systems Analyst (Change Control) is the Change Analyst for Document Control
and Change Control. As Quality systems analyst you ensures the continuous education, implementation and improvement of Quality Systems and compliance with QS Regulation and ISO within the Leiden facility. The Quality Systems Analyst ensures that the Leiden Plant, Document Control and Change Control Processes and structure meet all business and regulatory requirements. Responsible for Site Records Management and Site Record Management representative for Mentor Leiden.

Job description
Your responsibilities in the role of Quality Systems Analyst:
  • Ensure quality systems are effectively deployed;
  • Performs periodic checks to verify appropriate application;
  • Maintain regular interface with Management;
  • Assist in the development of Quality Metrics;
  • Achieve company's Quality goals;
  • Use statistical methods, quality tools and computer generated reports to continuously improve process capability;
  • Provide education/training as needed regarding Document Control and Change Control processes including MVI/Validation Documents;
  • Lead and participates in quality system improvement initiatives;
  • Conducts internal audits to determine compliance with quality management system standards as well as regulatory and customer requirements;
  • Determines root causes of quality issues and develops corrective actions and recommendations;
  • Establishes, maintains and implements communications to increase awareness and promote improvement of quality issues across the business;
  • Assists department head in implementing new product development procedures and documentation;
  • Assists with external audits, generating reports with corrective action plans and ensuring implementation of corrective actions in a timely manner;
  • Responsible for the Site Records Management being the Site Record Management representative;
  • Backup on other tasks within QS department to assure business continuity, if required.

Who we're looking for
The ideal candidate has a University/Bachelor’s Degree, at least a Lean/Six Sigma Green Belt and a background in statistics. You have minimal 2 years of related experience and preferably mathematical and analytical thinking skills. You have thorough understanding of medically regulated plant operations, including knowledge of industry standards & regulations, processes and practices in a variety of different departments and operations.
Next to that you have good communication skills in English and it is an advantage if you have experience with auditing.
You have the ability to read, analyze, and interpret general business periodicals, to write reports, procedure manuals, related documentation and effectively present information.

Additional vacancy information
Contract:Temporary contract with CLS Services
Contactperson:René Kemps
+31 (0)31 (0)88 22 77 555


Opleiding WO
Ervaring Starter (0 - 3 jaar)


Interested? Send us a detailed curriculum vitae, accompanied by an application letter indicating your motivation. Please use our online application form. (Please use button *Direct solliciteren*)
(Vacancy number A1800082)
You can follow our vacancies on Twitter http://twitter.com/CLSServicesJobs .

For more information please contact René Kemps at +31 (0)31 (0)88 22 77 555


As a dynamic company CLS Services is dedicated to recruiting top level professionals in chemistry and life sciences. Clients appreciate our professionalism, flexibility and ability to come up with tailor-made solutions for any specialist function. Founders and directors Jan Paul Favier and René Kemps both have relevant technical backgrounds and extensive experience in high-level recruitment in the CLS Services sector. In short time we have built up an impressive track record and now serve multinationals as well as smaller and more specialized biotech, chemical, pharmaceutical and food companies.

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