QA Manager Digital & Software

Employer
CTC Resourcing Solutions
Location
Solothurn, Switzerland
Salary
Competitive
Start date
22 Nov 2022
Closing date
22 Dec 2022

View more

Discipline
Quality, QA / QC
Hours
Full Time
Contract Type
Permanent
Experience Level
Experienced (non-manager)
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Job Details

CTC are specialised industry experts who can help companies source the best talent and provide reliable HR and consulting services, support varied candidates in finding promising career opportunities and offer the latest in skill development training programmes.

QA Manager - Digital & Software - 5087 (ADA)

Our client is a leading Medical Technology company in Switzerland. It is headquartered in Central Switzerland and has a global network of production sites, subsidiaries and sales partners. For our client’s Quality and Assurance department, we are looking for a Quality Assurance Manager - Digital & Software for a permanent role to be based in Central Switzerland area.

Main Responsibilities:
  • Ensure a common standard within the company with regard to quality and regulatory requirements.
  • Provides full product lifecycle quality oversight including all pre-production (i.e. Plan, Design, Validation and Release) and post-production (i.e. availability management, problem management, change control, etc.) for commercial and digital health assets, mobile applications including health software and SaMD applications
  • Reviews/approves technical documentation constituents
  • Provides necessary guidance and support to meet design control requirements
  • Ensures outstanding inspection readiness for systems in the portfolio

Qualifications and Experience:

· Relevant Swiss working/residency permit or Swiss/EU-Citizenship required;
  • A Bachelor’s degree in Computer Science, Information Systems, Business Administration or other related field is preferred
  • ITIL, Agile, and/or Scrum Master certifications are a plus
  • At least 4 years of dynamic experience in the pharmaceutical/medical device/biotech or other regulated industry is required
  • Knowledge of Software as Medical Device (SaMD) is desired, including ISO 13485, IEC 62304, IEC 82304, ISO 14971
  • Experience in authoring or reviewing validation protocols, Non-conformities, Change Requests, SOPs, Validation Plans and Reports is mandatory

Company

Due to our reputation for excellence and our proactive approach to networking and promoting CTC, we are able to engage the very best talent, and consequently work with the very best employers in the market who are serious about bringing talent to their organisation. If you are looking for a reliable partner with:

  • Established client and candidate network
  • Excellent and detailed knowledge of local requirements
  • Solid reputation
  • Quick and flexible approach to recruitment
  • High quality of service
  • People focused

Depending on your needs and situation, we offer business partnerships with flexible solutions that can be tailored to your specific resourcing needs - all with a collaborative, open, and friendly approach.

We recruit in the following areas:

  • Pharma/Biotech:
    • Clinical Development
    • Pre-Clinical Development
    • Regulatory affairs
    • Pharmacovigilance
    • Sales & Marketing
    • Supply Chain
    • Communications
    • Medical Affairs
    • General Management
  • Medical Devices / MedTech:
    • Engineering & Product Development
    • Quality & Manufacturing
    • Technical Writing
    • Regulatory Affairs
    • Sales & Marketing
Find Us
Website
Telephone
+41 61 695 88 66
Location
Münchensteinerstrasse 41
Münchensteinerstrasse 41
4052
Basel
CH

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