Quality Assurance Specialist - global Medical Devices company – Zurich

Health Care/Medicine jobs >> Pharmaceutical

Negotiable

Permanent

Description

Quality Assurance Specialist - global Medical Devices company – Zurich

NES Global Talent in Switzerland focuses purely in the Life Science sector where we support the Pharma, Medical Device, Biotech industries and work on QA, Technical and Regulatory positions. With a database that consists of over 2000 Life Science involved talents based in Switzerland and a contact that covers 90% of the job seekers we advertise our clients through all recruitment rotes on a daily basis.

Currently we support one of our clients in the Medical Device industry in Zurich. In order to strengthen their team there, we are looking for an experienced professional to join them as a Quality Assurance Specialist. Their current and upcoming global projects in Q2 and Q3 predict growth in the QA department and they've reached to us for our support.

Responsibilities:

Operate in close collaboration with production and assure a timely handling of all quality relevant topics and compliance with current FDA, EMEA regulations and ISO 13485.
Assure that all intermediate and final products manufactured in Majorenacker site for Production Medical Devices (PMD) meets requirements according to the company specification and current guidelines.
Assure that quality systems such as deviation system and change control system are consistently followed.
Escalate any issues which may impact on the compliance status or product quality of our specific products.
Batch disposition on product release through entire manufacturing and packaging process
Review and Approval of SAP master data including recipes, BOM, DMD/AGG codes and etc.
In time Batch Record review and release for products
Batch release of semi-finished and finished goods (Autorelease by SAP).
In time processing of products Complaint and of NCs
Compliance to GMP, EHS and SOX specifications and guidelines associated with each function.
Construction and review of quality documents (e.g. SOPS, Q-Agreements etc.)
Owned Change Owner function and assess changes in area of responsibility
Filing and archiving of Batch documentation and samples.
Procurement for QA Business Unit
Creation of product certification in eLIMS
Download, edit and enter scorecards data, trend reports and governance processes
NCs and complaints handling
Represents the staff QA specialist in the quality department regarding specific products
Must-haves

High level of quality mindset for all tasks. Strong analytical thinking.
Experience working in GMP regulated industries
Experience in Nonconformance investigations, CAPAs and complaint investigations
Experience with change controls
Capable to of creating and revising work instructions and procedure
Strong written and verbal communication skills
Fluency in German and English written and verbally
Nice-to-have

Experience with electronic quality systems
Experience supporting 3rd party inspections and audits (e.g. FDA, Notified Body, or Customer Audit)
Minimum Bachelor’s degree in Engineering, Life Sciences, or Physical Sciences
3-5 Years Experience In Highly Regulated Industry Preferred
Medical Device industry experience (FDA and ISO 13485) preferred
Practiced in MS Office products
Experience with SAP
What is in for you:

Detailed conversation, introduction and preparation for a successful application with an experienced consultant
Transparency and support throughout the application process
Negotiation with clients for better work/contract conditions
Follow up and update on market relevant opportunities
Experience in within the EU is needed. Please note we can only accept applications from candidates who hold valid European Union passport and are able to work in Europe without visa sponsorship.

For a confidential discussion about quality assurance vacancies, then send your CV to me, Martin Ivanov, Senior Recruitment Consultant for Switzerland.

Keywords: medical device, global projects, management, MDR, MDD, medical devices, Quality, Quality Assurance, QA, Engineering, CAPA, CAPAs, Audit, Audits, Quality Management System, Quality Management Systems, QMS, ISO 9001, ISO 13485, FDA, QSR

Established in 1978, NES Global Talent provides a complete range of contract and permanent talent solutions to the Oil and Gas, Power, Construction and Infrastructure, Life Sciences, Manufacturing and IT sectors worldwide. With more than 40 offices in 28 countries, we are able to provide our clients with the engineering and technical expertise they need, wherever and whenever it is needed. Offering far more than a traditional recruitment service, we fully support our contractors while they are on assignment with everything from securing visas and work permits, to providing market leading benefits packages and accommodation, ensuring they are safely and compliantly able to support our clients
  • 1
  • Negotiable
  • None
  • None
  • CV-124998
  • Permanent
  • 3

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