Quality Engineer

7 days ago

Singapore GYROGEAR PTE. LTD. Full time

**Award-winning medical device startup (GyroGear.co **) has a single opening for a skilled Quality Engineer at our London HQ. We are developing intelligent wearable devices to stabilise hand tremors for 200 million people globally.

**JOB PURPOSES**:

- The Quality Engineer role is responsible for ensuring processes are implemented and maintained in accordance with the regulatory requirements of the MDR 2017/745 as well as those outlined in ISO 13485:2016 and 21 CFR Part 820.
- The role will entail management of the document and change control process within GyroGear’s QMS, also ensuring that training and competency are applied to all procedures in accordance with the ISO 14971:2019.
- The role will also require staff to understand design and development and the ability to support the quality department in the creation and maintenance of the design history file/ technical design dossier.
- The role will work closely with both the QA/RA Manager and the Engineering department to ensure that design transfer to manufacture is carried out effectively and that appropriate control is applied to manufacturing sites engaged in the manufacture and assembly of the GyroGlove.

**RESPONSIBILITIES:**:We are looking for an Quality Engineer whose responsibilities include, but are not limited to:

- Ownership of the Document and Change Control Process:

- Responsible for drafting and routing of documents through the QMS
- Responsible for management of change and maintenance of records within the QMS.
- Ensure that all drawings and specifications are transferred into the QMS, formally approved, and maintained throughout the design transfer process.
- Ownership of the Training and Competency Process.
- Responsible for ensuring training is implemented across all areas of the QMS.
- Responsible for ensuring competency is established against each process and procedure within the QMS. The role will require that competency evaluations are documented for all GyroGear staff against each area of the QMS.
- Responsibility for Quality guidance to GyroGear staff across all areas of the business.
- Ownership of Internal Equipment Control.
- Responsibility for ensuring that the equipment calibration and preventative maintenance schedule is established.
- Oversight of calibration and preventive maintenance processes within GyroGear and at supplier and contract manufacturer sites.
- Responsible for final sign off on calibration and preventive maintenance records at GyroGear.
- Execution of internal audits across the QMS within GyroGear.
- Delegated responsibility for supplier audit execution where required.
- Responsible for working with the Engineering department to maintain and update FMEA documentation.
- Delegated responsibility for Quality approval within the QMS.
- Delegated responsibility for Manufacturing Quality Control at contract manufacturing and supplier sites.

**QUALIFICATIONS**:

- Minimum 5 years working in the Medical Device or IVD industry.
- Experience working within an ISO 13485 regulated framework.
- Trained ISO 13485 internal auditor preferred.

**WORKING CONDITIONS**:

- The role will predominantly be home based, with an expectation to attend the office when required to support QA/RA activities such as internal and external audits, design reviews and to support business needs.

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