Quality Assurance Specialist
at Dexis
Tuusula, Etelä-Suomi, Finland -
Start Date | Expiry Date | Salary | Posted On | Experience | Skills | Telecommute | Sponsor Visa |
---|---|---|---|---|---|---|---|
Immediate | 05 May, 2025 | Not Specified | 06 Feb, 2025 | 3 year(s) or above | Regulatory Requirements,Communication Skills,International Environment,Regulations,Lean Culture,English | No | No |
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Description:
JOB DESCRIPTION:
We are looking for Quality Assurance Specialist to be in charge of various quality assurance activities as part of our QARA team in Tuusula.
As a Quality Assurance Specialist, you will have an active and important role in supporting R&D, Maintenance Engineering, Customer Care, Sourcing, Product Management and Operations in their efforts to ensure high product quality and global regulatory compliance.
- You will be responsible for evaluating incoming customer complaint data, identifying safety related and potentially reportable complaints and gathering needed information for complaint closure.
- In addition you will be analyzing various quality data, identifying production, process or product issues, and coordinating implementation of solutions.
- You will use problem solving methodologies for in-process, supplier and customer quality issues.
- The role will also include support for new product development, engineering and manufacturing changes to ensure compliance against regulatory requirements and internal procedures.
- You will participate in internal and external audits. You will have a great opportunity to further develop and improve our company’s quality management system processes and tools.
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JOB REQUIREMENTS:
We expect you to
- have an Engineering Degree and 3+ years of experience in a quality engineering or quality assurance role
- have proficiency both in spoken and written Finnish and English
- demonstrate excellent communication skills across business functions and cultural boundaries
- enjoy working in a fast-paced, international environment
- have proficiency in Microsoft Office applications.
Additionally, the following will be considered an advantage:
- experience in medical device industry and understanding of international medical device standards, regulations and risk management
- knowledge and interest in Lean methods and processes.
As a person, you are self-motivated and able to work independently, yet an efficient team player, who strives for reaching the goals. You take initiative, learn quickly and enjoy facing challenges and solving problems. You have a sense of urgency and strong attention to detail. You understand the importance of your role in complying with the rigorous regulatory requirements for healthcare technology and ensuring our imaging products fulfill or even exceed the high-quality expectations of our end-users.
We offer you inspiring challenges in a rapidly growing global healthtech business and an opportunity to work within a strong Lean culture. The position offers interesting and varying responsibilities and an attractive opportunity to excel your professional expertise as a part of our global QARA team.
Responsibilities:
- You will be responsible for evaluating incoming customer complaint data, identifying safety related and potentially reportable complaints and gathering needed information for complaint closure.
- In addition you will be analyzing various quality data, identifying production, process or product issues, and coordinating implementation of solutions.
- You will use problem solving methodologies for in-process, supplier and customer quality issues.
- The role will also include support for new product development, engineering and manufacturing changes to ensure compliance against regulatory requirements and internal procedures.
- You will participate in internal and external audits. You will have a great opportunity to further develop and improve our company’s quality management system processes and tools
REQUIREMENT SUMMARY
Min:3.0Max:8.0 year(s)
Pharmaceuticals
Production / Maintenance / Quality
Software Testing, Clinical Pharmacy
Graduate
A quality engineering or quality assurance role
Proficient
1
Tuusula, Finland