Quality & Process Specialist (f/m/o) 100%

Peppercorn - talent acquisition. For more than 30 years, we support our clients in the personnel recruitment for fixed and temporary placements. We are a financially independent company within the FAVORIS group.

For an international pharmaceutical company located in STÄFA we are looking for a:

Quality & Process Specialist (f/m/o) 100%

The Quality & Process Specialist support the team Corp. ME in regards of quality aspects (QMS) and MDR, MDSAP / ISO 13485 / ISO 9001 requirements, translating them into our engineering environmental, considering our needs and supporting our Corp. ME vision. The ME team is the connection between our R&D and our production. The team develop the production processes, define the production set-up including all equipment, tools and documentation. After implementation in our global production network ME support all production sites in all technical and quality related questions.

Your tasks:
  • [endif]Guidance and improvement of processes, including corresponding descriptions, considering constant monitoring of changes within regulatory aspects
  • Training / support of new employees within Corp. ME in the area of high level Corp. ME Quality & Process landscape
  • Quality assurance for project deliverables related to our process landscape
  • Support project leaders, engineers and developers with interpretation and implementation of different standards, guideline and regulatory aspects
  • Active contribution during audit preparation and also while audit gets executed, can also include explanations in front of the auditor
  • Support and execute related NCs and CAPAs
Your profile:
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  • [if !supportLists]Degree in Engineering and / or Quality & Regulatory Management
  • Experience working in the area of process development, product industrialization or product development preferably in a medical devices environment
  • Knowledge in regulatory and quality management is a must (MDR, FDA 21 CFR 820, ISO13485)
  • Committed and quality oriented person combined with good communication skills
  • Fluent German and good English skills (written and spoken)
  • Very command of MS Office programs
Are you interested?

We look forward to discuss further details with you.

Peppercorn Human Experts AG
Auberg 2
4051 Basel

Nancy Sommer
Telefon: 058 255 31 02

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