Quality Assurance Engineer
Our Client is an innovative R&D Biotech that has many agents at various trial phases and successfully achieved FDA Approval in 2015 for a new medical device within Oncology. They have a start up feel about them which creates a fast-paced, highly dynamic and entrepreneurial culture with an emphasis on being patient centric. They went “live” in 2015, so they are still setting and building up the structures and processes and are now in a role out phase for their new product. They now seek a Quality Assurance Engineer to be based close to Zug on a permanent basis.
- You will be part of a team of 5 working on internal audits and manufacturing;
- All manufacturing is outsourced therefore you will be expected to engage with 3rd party sources to ensure quality and regulations are adhered to the highest standards;
- Due to the unique nature of the company having direct contact with their patients, this allows them to get feedback directly, so if a patient isn’t satisfied with something on the device, they can look at making modifications and implement new product changes quickly and efficiently – you will be integral to the process ensuring changes are made to spec;
- You will be responsible for the contract manufacturing experience and/or supply chain and will understand the release processes and sign-off procedure;
- Ideally, you will have direct experience with internal audits (deviation and change control);
- This role is non clinical.
Qualifications and Experience:
- BSc in Engineering or Scientific qualification;
- Minimum of 5 years experience in Medical Device industry or pharma;
- In depth understanding of internal audits and supply chain;
- Fluency in English (verbal and written) and excellent communication skills;
- Ability to efficiently organize and prioritize work within a multifaceted framework and set deadlines;
- Excellent organizational and record-keeping skills with high standards and attention to detail;
- Relevant working/residency permit or Swiss/EU-Citizenship required.