BiVACOR is looking for a Quality Engineer (QE)
The Quality Engineer (QE) will develop and execute test procedures and works with the senior management to assist in implementing a QM system in accordance with ISO 13485 and 21 CFR 820.
The QE will manage daily Quality Assurance (QA) activities by developing and performing of validation & verification test and will also complete inspection and assembly activities. The QE will work with internal engineering staff from mechanical and electrical engineering backgrounds to the support manufacturing planning. The QE will act as a liaison between the company and external vendors/suppliers to ensure QA activities are sufficiently undertaken to support product development.
BiVACOR is looking for motivated and flexible team members, who are keen to contribute to this active and dynamic project. Strong organizational, time management, and technical skills paired with an analytical and problem-solving thinking in a deadline driven environment is needed. This role requires the ability to work with minimal supervision and offers the opportunity for a further career development towards a stronger QM.
As a young company eager to advance, its products from laboratory to clinic, BiVACOR is committed to establishing Quality Assurance practices that are supportive of ongoing R&D activities.
Develop and validate test methods, which address the User Needs and Product Specifications.
Supervise and perform inspection, assembly and V&V testing.
Design and build test fixtures, including maintenance.
Compile and communicate validation plans and reports documenting performance.
Create, edit, and maintain documentation related to design controls and quality system guidelines.
Assist in the development of design input specifications and study designs.
Write and review Standard Operating Procedures (SOPs) and Work Instructions (WIs).
With the internal and external QA personnel;
Assist in the documentation suitable for regulatory submissions,
Assist in conducting risk management activities and updating FTA, design and process FMEA.
Interact with external suppliers/vendors.
Execute quality agreements and quality control plans in collaboration with suppliers.
Perform supplier audits and participate in supplier visits.
Define, develop and implement processes and technical solutions to support current product designs, optimize manufacturing /reliability, and improve quality.
Bachelor’s degree or higher in Mechanical Engineering or similar, plus at least 2 years work experience in medical device development or quality assurance.
Experience with electrical/mechanical systems for medical devices in a regulated environment.
Understanding of design controls, including design (customer and product) requirements, performance specifications, and verification and validation testing.
Working knowledge of quality systems, risk management tools and applicable standards, such as 21 CFR Part 820 and ISOs 14708, 17025, 14971, 13485 is preferred.
Working knowledge of gauges and precision inspection equipment/instruments.
Previous experience in a Design Assurance role with experience through all phases (from product conception through commercialization) desirable.
Proficient with Microsoft Office and project planning software packages; experience with DAQ systems such as dSPACE, LabChart, LabVIEW highly desirable.
To apply, submit your resume and cover letter to firstname.lastname@example.org