Product Quality Planner (m/f/d)

Product Quality Planner (m/f/d) - GMP/Production / in-vitro diagnostic / ISO 13485, IVDR, FDA 21 CFR part 820 / procure to-pay / Process Management methodologies (Lean, Six Sigma)/ test equipment quali?cation / test method validation / English and German

Project:
For our customer Roche Diagnostics International AG based in Rotkreuz we are looking for a Product Quality Planner (m/f/d).

Background:
Global External Manufacturing is the competence center for parts and products in the diagnostic workflow, manufactured by external suppliers. This includes the development of new products, product care activities, the assurance of supply as well as the supplier selection and maintenance in close collaboration with Procurement.

As a Product Quality Planner, you are responsible for the planning and state of the art measurement of the technical test speci?cations. This role assures that the products are tested compliant to the regulations, including statistical sampling plan and test procedures. The Product Quality Planner provides the necessary training of test procedures to chapter members and stakeholders outside of the organization.

The perfect candidate has a M.Sc- or B.Sc. degree in Engineering, Natural Science or related disciplines or apprenticeship with high degree of subject matter expertise and at least 3 years of relevant work experience in a GMP regulated company.

Tasks & Responsibilities:
• Transfer product speci?cation into test equipment requirements (URS)
• De?ne and develop test equipment
• De?ne acceptance criteria for test equipment
• Accountable for creation of test plan
• Implementation of test planning at supplier and RDI
• De?ne sample size for in-process control (IPC), product release testing and incoming goods inspection
• Conduct internal and supplier trainings regarding product quality inspection
• Accountable for test equipment quali?cation, test method validation, including correlation studies to RDI test equipment
• Technical Q&V documentation review at supplier regarding test equipment quali?cation, test method validation
• Responsible for review of ?rst article inspection (FAI) incl. veri?cation of the tolerance situation
• Technical assessment of changes of test equipment and test planning

Must Haves:
• M.Sc- or B.Sc. degree in Engineering, Natural Science or related disciplines or apprenticeship with high degree of subject matter expertise.
• 3+ years of relevant work experience in a GMP regulated, producing company
• Experience in IVD product manufacturing and testing, and with in-vitro diagnostic related regulations, such as ISO 13485, IVDR, FDA 21 CFR part 820 etc
• Knowledge of Process Management methodologies (Lean, Six Sigma, etc.)
• Experienced in test equipment quali?cation and test method validation
• Ability to think strategically and systemically, willingness to try new ideas and participate in changes
• Self-motivated, autonomous, structured and goal-oriented mindset with a solution oriented balance of short term mitigation and long term solution
• Ability to effectively communicate with all levels of the organization by establishing credibility and building rapport
• Performing well under pressure and decisiveness
• Excellent communication skills in German and English
• Travel required up to 10%

Reference Nr.: 924030SDA
Role: Product Quality Planner (m/f/d)
Industrie: Pharma
Workplace: Rotkreuz
Pensum: 80 - 100%
Start: 01.04.2025
Duration: unlimited
Deadline: 24.02.2025

If you are interested in this position, please send us your complete dossier via the link in this advertisement. If this position does not fit your profile and you wish to be considered for another position directly, you can also send us your dossier via this ad or to jobs[at]itcag[dot]com.
Contact us for more information about our company, our positions or our attractive Payroll-Only programme: +41 41 760 77 01.

About us:
ITech Consult is an ISO 9001:2015 certified Swiss company with offices in Germany and Ireland. ITech Consult specialises in the placement of highly qualified candidates for recruitment in the fields of IT, Life Science & Engineering.
We offer staff leasing & payroll services. For our candidates this is free of charge, also for Payroll we do not charge you any additional fees.