Inflammatix is seeking a highly motivated Junior Quality Engineer to support quality and safety assurance of our facilities and in-vitro diagnostic (IVD) products. This role is based in our facilities in Lisbon, Portugal. The Junior Quality Engineer will work daily to ensure quality, safety, and compliance in all Inflammatix activities. The role also supports work required for regulatory compliance related to Quality System certification and FDA, EU and other regulatory authorities. We seek an individual compelled to join our dedicated team to bring breakthrough medical technologies to market that can favorably impact patient lives across the globe. This is a fantastic opportunity to gain experience in early-stage development of a growing biotech company.
PRIMARY RESPONSIBILITIES:
- Support local manufacturing operations through careful review of manufacturing and quality control records (DHRs), NCRs, and rework procedures, in full compliance with the quality system in place
- Support design transfer activities, specifically creating or updating material specifications, reviewing manufacturing and inspection and test procedures and records, and executing equipment qualification and spreadsheet validation work in close interaction with other internal teams
- Support supplier management activities such as qualification, problem solving, support engineering, as needed
- Support document control activities such as document creation and maintenance in the eQMS platform and monitoring of training assignments
- Support all activities related to Equipment Management for the Lisbon site, as indicated by the direct manager
- Support Lisbon site operational safety and compliance with all necessary stakeholders, proactively implementing new processes as needed
- Support maintenance of lab chemical inventory and SDS log, as well as other material inventory as needed
MINIMUM QUALIFICATIONS:
- BS/MS, preferably in biological sciences, biomedical engineering, biotechnology or related field.
- Strong written and verbal communication skills, including English level of at least C1.
- Proficiency with Microsoft Excel, Word, PowerPoint, and Outlook.
- Ability to work in cross-functional teams and support a breadth of tasks.
- Strong sense of accountability.
- Strong attention to detail, self-motivation, interpersonal and communication skills.
PREFERRED QUALIFICATIONS:
- Understanding of laboratory processes, equipment, and infrastructure
- Previous experience working in GLP, GMP, CLIA or ISO 13485 environment
- Previous experience working in bio/biotech/pharma company
- English level C2
- Experience with in vitro diagnostics
SALARY AND CLASSIFICATION:
- Classification: Full-time position at Inflammatix Portugal facilities in Lisbon, Portugal
- Compensation: Package is competitive/commensurate with experience
- Benefits: Medical insurance, transportation allowance, technology allowance
