Sqa mérnök állások, munkák

• A sorozatgyártás során beépülésre kerülő alkatrészek ellenőrzése, minőségfejlesztése, jóváhagyása
• Új modell bevezetési projektek támogatása, beszállítói PPAP csomagok felülvizsgálata és elfogadása
• Az alkatrész beszállítók fejlesztése, auditálása, értékelése

Prepare, support the creation and review and execute the release of all technical documentation for digital health and software products ensuring compliance with applicable standards and regulatory requirements such as IEC, IEC...

Design and write automated test cases Expand test automation coverage Close collaboration with developers and product team Independent test case planning and implementation...

• Maintaining and continuous improvement of the Quality System, including the associated management documentation and ISO certifications
• Planning and coordination of internal audits as per Internal Audit Plan
• Planning and coordination of the yearly Management Reviews including Reporting

Címkék, feliratok előkészítése, felragasztása a termékekre Minőségellenőr munkatárs napi munkájának támogatása Raktár terület napi szintű takarítása, a használt tisztítószerekre vonatkozó előírások és higiéniai elvárások betartásával Berendezések tisztítása, beállítása, kisebb karbantartási munkák...

• Take part in the definition of quality objectives for suppliers and supplier management
• Conduct quality audits at suppliers and service providers
• Support Purchasing in supplier selection.

• Acting as a key contact to IEE customers for quality-relevant topics during development and serial production
• Handling customer complaints
• Organizing and following up of customer audits
• Minimizing quality risks
• Preventing field actions
• Minimizing warranty costs and scrap costs

• Developing and maintaining sterility assurance and contamination control strategies for aseptic processing
• Leading risk assessments for aseptic process, single use systems and critical interventions, and ensuring compliance with authorities relevant Guidance such as Annex 1

• In-process controls, release and stability tests using HPLC-based analytical methods 
• DLS-based analyses; pH, IR, and wet chemical analyses
• Visual appearance test of finished drug product for batch release and stability 

• Provides direct supervision, resolves personnel issues, conducts performance evaluations, and performs managerial discipline, as necessary.
• Directly reports to include quality control supervisors.

• Develop and maintain test plans, test cases, and test documentation
• Test desktop applications for functional and performance requirements
• Conduct field tests with drones and sensors (eg, methane detector, magnetometer, echo sounder, GPR) to validate HW/SW integration

• Implement and maintain quality procedures in accordance with ISO
• Lead or support internal audits.
• Manage and drive the internal non-conformities process until issues resolutions.
• Manage Non conform product segregation and containment actions.

• You are responsible for quality related topics like change control, deviations and/or complaints related to DS products at CMOs
• Define together with the CMO effective CAPAs and track the timely implementation

• Responsible for receiving incoming green coffee samples
• Prepare and ensure timely dispatch of samples to our customers
• Provide support to the trading team by cupping and grading coffees in accordance with company procedures and business requirements

• Ensuring process adherence for the pre-market procedures
• Completeness of design history files and regulatory submissions
• Regulatory and process conformance for development and maintenance projects as a member of cross-functional teams