Quality Engineer, Medical Device
4 days left
- Full Time
ProClinical is currently seeking a Quality Engineer, Medical Device, for a start-up biotechnology aspiring to transform human health. This position supports quality assurance activities related to quality system compliance and continuous improvement. The ideal candidate will have a Quality Assurance background in an in vitro diagnostic or molecular reagent company and/or a product development background in molecular biology products or molecular diagnostic products company utilizing nucleic acid technology (e.g. PCR, sequencing, etc) is a plus.
- Manage or support the document control program as well as suggest and implement improvements to existing process.
- Support the training program as well as suggest and implement improvements to existing process.
- General support and may assist in the investigation and resolution of nonconforming events and CAPA projects.
- Work with management to improve quality system policies and procedures.
- Assist in internal and external audits.
- Write and/or review documents.
- Perform other duties as assigned.
- The Document Control Specialist will follow the financial guidelines set by manager.
- Attend and participate in team meetings, and interact in a positive, professional manner.
- Ability to exercise independent judgment Works under limited supervision
- Skills: Knowledge/Skills:
- Excellent problem solving and analytical skills Effective interpersonal and communication skills and capable of supporting cross-functional project goals.
Skills and Requirements:
- Degree in Molecular Biology or related field plus 1-2 years of industry experience; in vitro diagnostic or molecular reagent quality assurance preferred or
- 2-4 years of direct work experience in QA, including all aspects of device/diagnostic quality systems Experience with ISO quality management systems Excellent problem solving and analytical skills.
- Effective interpersonal and communication skills and capable of supporting cross-functional project goals.
- An understanding of GDP and/or ISO Standards is a plus.
- Quality engineering experience is a plus.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Owen Bach on or upload your CV on our website - .
A full job description is available on request.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.