Quality Specialist

Quality Specialist

Randstad Professionals are one of the leading recruitment companies in Switzerland and with a dedicated IT contracting team in Zurich. We are excited to help you in your search. We focus on finding the best contracts for the best contractors.

We are looking for a Quality Specialist for our client based in Solothurn.

Role Objective

Quality Specialist for a Project to introduce product variants into Supply Chain. The Project is a global, multi-site, multi-department Supply Chain Compliance project.

The objective is to define and implement across the Supply Chain, a product variants management solution.

The Quality Specialist will be the Subject Matter Expert for the Quality and Compliance changes in business process and technologies of the different work streams. He/She will support all quality aspects related to systems, process and regulatory rules to the project and will work closely with the Project Leader.

Role Description

The Quality Specialist will be the Subject Matter Expert and support all system, process, procedures for End to End multi-variant readiness across all systems, BU and worldwide sites. Liaise with all key stakeholders in building and executing on the Multi-variant readiness. Work directly with the Plant Quality Managers at the sites in the clients network to prepare and execute variant introduction.

Quality work stream key responsibilities

-Support process and technology mapping related.
-Deliver mitigated risk assessment across business (PFMEA).
-Implement mitigations and assess control of the solutions.
-Organize and conduct system validations across business.
-Refine compliant distribution requirements.
-Change/Update procedures as required with other work streams.
-Prepare and execute system testing plan.
-Understand dependencies across work stream for change impact.
-Identify critical path and risks to project timeline.
-Issue status reports and effectively communicate to upper management.
-Work closely to support all testing.
-Update the full-scale End to End Business quality related flow and associated communication documents.
-Quantify the resources needed to achieve work stream project goals.

Core Team Responsibilities

- Develop, confirm, commit & deliver FPOs
- Identify their required resources/Extend team members
- Rigorous participation in core team meetings
- Communicate Key Deliverables status/issues to core team
- Support other Core team members
- Explain communication plan to extended team members and functional management
- Stay with project team until the project close-out

1. Qualification:

University/Bachelor's Degree or Equivalent in a Life Science, Engineering, or Physical Science discipline
Integrity around estimations and communications

2. Knowledge:

Essential:

1. 3+ years of relevant experience.
2. Fluent working in English. German or Italian are a plus.
3. Project leadership experience.
4. Previous proven Quality experience on large scale enterprises on medical devices requirements and compliance knowledge
5. GMP, GDP, ISO 13485, CFR 820
6. FMEA/Risk approach/Mapping experience
7. Operational Equipment qualification and/or CSV validation experience

Excellent cultural awareness.

Supply chain experience in medical device or pharmaceutical industry

3. Skills

Influencing and managing others.
Strong organization skills.
Can drive continuous process improvements.
Having the ability to work at both a macro and micro level as required.
Ability to translate complex situations into simple working solutions.
Proactive leadership approach with demonstrated skills in delivering major programs on time and within budget.
Proficient user of MS Office, Excel, Word, Powerpoint, MS Project

We are looking forward to receiving your full application.

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