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Quality Assurance Engineer
Quality Assurance Engineer
Fulltime (40 hours)About the Job:
We offer a challenging position for a (starting) Quality Assurance Engineer professional in an innovation driven Medical Device Company. You work closely with the Quality Assurance Manager; you are part of the IMDS QA team where you take ownership for driving compliance of our operations – and development process and the quality of our products. You enjoy working in a multi-disciplinary environment, you are highly skilled in communication and you have a can-do attitude. You realize that quality is of paramount importance and you are passionate about delivering solutions that truly stand out.
About the Tasks & Responsibilities:
The Quality Assurance Engineer participates both within an Operations environment as well as a New Product Development environment. Typical tasks for the Quality Assurance Engineer are:
- Review of Engineering -, Qualification- and Validation protocols and reports
- Review of New Product Development documentation
- Review of Specifications, Calibration- and Maintenance records
- Maintenance of Quality Management Procedures, – Guidance’s and – Templates
- Prepare and organize the Quality Management System Review meetings
- Coordinate handling of Non-Conformance Records, CAPA’s and complaint investigations
- Coordinate Cleanroom Monitoring and Corrective Actions
- Coordinate Bioburden Monitoring, Endotoxin Monitoring and Periodic Dose Audits
- Train new employees on Quality Management System
- Prepare and execute internal audits (ISO 13485, cGMP) and DHF audits
About the Job Requirements:
- BSc or MSc degree in exact sciences (e.g. Business Engineering)
- Strong feeling for an engineering environment
- Some experience in Quality Assurance, either through college or internship or in work experience
- Highly committed, respectful, trustful, eager and demonstrates ownership
- Creates alignment between cross functional team members through effective communication and seeks cross-function cooperation
- Has sufficient technical knowledge to enable high level communication with development– and manufacturing engineers
- Able to write clear reports in English, delivers presentations effectively to small and larger groups
- Can define objectives and break down into executable tasks with scheduling and tracking for overall plan execution; can prioritize activities by importance and meet tight deadlines.
About the Company:
IMDS (Interventional Medical Device Solutions) in Roden, The Netherlands, is an innovative and international high-tech organization and is dedicated to improve the patient outcome of percutaneous coronary interventions (PCI). With strong focus on game changing in-house technology, we develop unique product solutions enable advance treatment options. IMDS is equipped as a Centre of Excellence in order to develop, improve and manufacture innovative solutions for Medical Devices. When you join IMDS, you are part of a highly motivated team that is helping to improve quality of life. IMDS offers the excitement and growth potential of an agile company with the strength and stability of an established industry leader. The environment is fluid and fast-paced and the people work together to make a difference every day. The atmosphere is friendly and team-oriented. Working at IMDS gives you the opportunity to make a positive impact on the lives of others. IMDS is committed to building and maintaining a workforce that reflects the diversity of its global customer base.
About what we offer:
- Engaged international working environment in a modern working location
- Challenging job position with corresponding responsibilities
- Personal development to become a professional Quality Assurance Engineer in the leading Medical Device Industry
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