Supplier Quality Engineer

Presentation

Mölnlycke Health Care is a world-leading medical products and solutions company that equips healthcare professionals to achieve the best patient, clinical and economic outcomes. We design and supply products and solutions for use in wound treatment, pressure ulcer, infection prevention and surgery.

Are you organized, self-going and ambitious? Are you driven by results and improvements with experience from Supplier Quality? This could be the next job for you!

Mölnlycke Health Care is now recruiting a Supplier Quality Engineer to the headquarter in Gothenburg. In the role as Supplier Quality Engineer at Mölnlycke Health Care you will ensure that the suppliers (raw material and components) are qualified, evaluated and approved in accordance with Mölnlycke's requirements, applicable quality-, environmental- and ethical standard requirements and regulations.

Selection and interviews will be held continuously, welcome with your application!


Arbetsuppgifter

In the role as Supplier Quality Engineer you will coordinate evaluations and validations of the supplier’s product development and products of raw material and components. You will lead and follow-up the development of applicable processes to secure compliance and to enhance efficiency and continuous improvements. The Supplier Quality Engineer will act as supplier manufacturing approval owner as decided in projects (SQA or R&D) and sign off of Quality agreements with suppliers (in addition to R&D and Procurement).

You will lead, plan and follow-up supplier audits and quality complaints at suppliers. In order to do that, you are in support of Supplier Quality Management activities at local sites and support suppliers in relation to materials and components to determine critical quality parameters regarding processes, test methods, specifications and protocols in relation to development projects, audits and/or severe quality problems. In this role you will lead or participates in CAPA, FMEA and other failure investigation activities related to suppliers. You will also plan and support suppliers yearly audit plan and continuous evaluation of suppliers performance through KPIs, Meetings and scorecards.

The Supplier Quality Engineer is also involved in validation of new suppliers and collaborates both externally and internally with many different functions such as purchasing, quality control, R&D and more. You will perform process validation and participate in the annual Procurement Strategy work. Also, you will develop, improve and implement new and existing quality system requirements to improve business performance.

Key decisions:
- Supplier qualification, evaluation and approval owner
- Follow up supplier’s performance and decide actions to be taken to correct, improve or change suppliers, raw materials or components.
- Decisions related to supplier quality audits
- Management of the Approved Supplier List
- Quality related decisions in designated projects
- Supplier CAPA management and escalated issues
- Decisions in quality system requirements to be implemented e.g. procedures, processes, policies and tools

There will be approximately 3-4 days of travel, once a month.


Utbildning/erfarenhet

We believe that the right person for this position has a quality- and process engineering degree or equivalent and has Supplier Quality Engineering experience.

Skills:

- Lead Auditor Certificate (ISO 9001, ISO 13485)
- Competence in ISO13485, MDD, Environmental standards, GMP, FDA
- Statistical process control, process validation and risk analysis
- Strong technical knowledge about key International/European standards such as EN13795, ISO10993, ISO11607 preferably for non-woven material, biocompatibility, packaging etc.

The person we are looking for has a cross functional team mind-set and is a clear communicator. We value persons for this role who are result oriented, structured and organized. We believe that you are responsible, analysing and engaged with good capabilities to both be detail focused as well as able to see the bigger picture. Furthermore, you need to be self-going and able to plan your work independently and organize work to make deadlines in time. Fluent English language.


Företagsbeskrivning

Mölnlycke Health Care is a world-leading medical products and solutions company that equips healthcare professionals to achieve the best patient, clinical and economic outcomes. We design and supply products and solutions for use in wound treatment, pressure ulcer, infection prevention and surgery. Our products and solutions provide value for money supported by clinical and health economic evidence.

Language

en-GB