Manager, Group Quality and material Compliance

We are recruiting a Manager, Group Quality and Material Compliance, to our Group Operations team (Mariehamn or Uppsala).

The Optinova Group is one of the leading global suppliers of advanced tubing solutions for the medical device industry, as well as fluoropolymer tubing for challenging industrial applications, with the purpose of improving quality of everyday life around the world.

Group Operations (GOPS) is responsible for the performance and development of cross-functional, group-wide operations, such as end-to-end processes and KPIs, distribution model, ERP system, product data management, quality & regulatory compliance, trade compliance, operations controlling, common materials sourcing and logistics services.

The Optinova quality is globally known and essential to our identity, as it is a differentiating factor in our market. Regulatory compliance is critical in the plastics industry. As the Manager for Group Quality and Material Compliance, you will support the group in staying top notch within these areas.

Your responsibilities :

Group Quality

- Ensure that Group and entities have necessary QMS, quality certifications and resourcing for quality activities

- Represent Optinova quality in customer and supplier negotiations

- Define Group level quality policies and processes, such as complaints handling

- Plan and organize group wide audit programs and support in QMS audits when needed

- Define and implement quality KPIs and related reporting

- Coaching and working with quality and material compliance resources in different entities

- Development and harmonization of quality IT systems and related processes

Material regulatory compliance

- Initiate and involve in proactive studies, risk assessments and group statements on material compliance legislation

- Organize material compliance activities within group and ensure adequate resourcing

To succeed in this role, you need:

-Experience in establishing and maintaining QMS

- Experience and preferably internal auditor qualification for at least some of the following quality standards: ISO 9001, ISO 13485, ISO 14001, NFS/EU 10-2011, IATF 16949

- Experience in leading in a matrix organization

- Experience from manufacturing industry

- Experience in using quality and document management IT systems

- Fluency in English and Swedish preferred

You also need to be a good communicator with excellent collaboration skills, as you will work with stakeholders within Optinova group as well as customers and suppliers.

We offer you an opportunity to work in an exciting industry in a global company that is expanding, where your focus area - Quality - is of uttermost value.

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Sista ansökningsdag

Please contact our hiring manager Mikko Hakala, +358 400 904660