Interim Quality Systems Analyst NCR/CAPA | Breast Implants | Leiden (NL)

Location: Netherlands

SIRE® is the market leader in Life Sciences recruitment. We believe the recruitment market needs to gear up in technology and continuous innovation. We like technology, in a Life Sciences market driven on science, we couldn’t stay behind; we drive Recruitment Science. Investing a majority of our turnover in technology enables us to use unique Resource Technologies. By using highly advanced algorithms, we enable our team of Resource & Data Strategists© to maintain the most advanced, detailed and complete Life Sciences network in Europe. This big data enables us to work Reverse Recruitment©: we first analyze the market in-depth before we go out to the market. Because we analyze the whole market, we can compare facts and data. This enables us to do Facts & Big Data Recruitment©, making sure we, or better yet, you find the right career!Our client is a professional Medical Devices organisation, based in Zuid-Holland Netherlands.

The Company

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. 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.

Role Description

The Quality Systems Analyst is the NCR-CAPA Site Lead. The Quality Systems Analyst 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 Nonconformity and Corrective and Preventive Action Processes and structure meet all business and regulatory requirements.

Responsibilities

1. Responsible for the overall management and effectiveness of the NCR & CAPA processes.
2. Representation of the site on the worldwide NCR and CAPA Teams.
3. Organize and lead the CAPA Review Boards.
4. Provide education/training as needed regarding NCR & CAPA processes including Bounding, and Failure Investigation/ Problem Solving.
5. Ensures compliance of NCR process, CAPA process and assigned projects with the FDA Quality System Regulation, ISO 13485, MDD, CMDR and other industry standards as applicable.
6. Responsible for analysis of complex statistical methods, quality tools and computer-generated reports to continuously improve process capability.
7. Leads and participates in quality system improvement initiatives.
8. Determines root causes of quality issues and develops corrective action and recommendations.
9. Establishes, maintains and implements communications to increase awareness and promote improvement of quality issues across the business.
10. Report NCR/CAPA scorecard results, as needed.
11. Ensures quality systems are effectively deployed and performs periodic checks to verify appropriate application.
12. Performs other duties assigned as needed.

Requirements

- University / bachelor’s Degree or Equivalent years of experience
- Requires a minimum of 2 years related experience. Medical device manufacturing experience preferred.
- Audit experience;
- Stakeholder management experience and able to facilitate and moderate meetings.

Other information

This is an interim position for 10 months until the end of 2019. It concerns a temporary backfill for someone who has a project elsewhere.

Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Cees Roffelsen.