Quality Assurance Manager ensuring compliance with GMP and regulatory standards for pharmaceutical products. Overseeing QA activities and maintaining a strong quality culture at the site.
About the role
- Quality Engineer at Datwyler ensuring compliance with regulatory requirements and supporting manufacturing processes. Collaborating to drive continuous improvement initiatives in a regulated environment.
Responsibilities
- Ensure compliance with ISO 13485, FDA 21 CFR 820, EU MDR, and other applicable regulatory and customer requirements.
- Provide quality engineering support for manufacturing processes, including molding, assembly, inspection, and packaging.
- Oversight process validations (IQ, OQ, PQ) and maintain validation documentation.
- Participate in PFMEA, Control Plans, and risk management activities.
- Oversight and support root cause investigations using tools such as 8D, Fishbone, and 5-Why.
- Support quality planning and risk assessments for new products and transfers.
Requirements
- Bachelor’s degree in Engineering, Quality, Science, or a related discipline.
- 2–5+ years of quality engineering experience in a regulated manufacturing environment, preferably medical device, pharmaceutical, or healthcare packaging.
- Experience with molding or precision manufacturing processes preferred.
- Strong knowledge of ISO 13485, FDA 21 CFR 820, Risk management (ISO 14971), Process validation.
- Experience with statistical tools and SPC.
- Proficiency in MS Office; experience with eQMS systems is a plus.
Benefits
- Health insurance
- Professional development opportunities
Job title
Job type
Experience level
Salary
Not specified
Degree requirement
Tech skills
Location requirements
Senior Quality Assurance Engineer at VIA focusing on integrating testing into engineering processes. Leveraging AI - driven automation to enhance QA efficiency and maintain security standards.
Principal Design Quality Engineer contributing to the compliance of medical software devices at Cleerly. Leading design quality engineering in the development and oversight of QMS and regulations.
SDET at CI&T focusing on automated and manual testing strategies for software quality. Collaborating with cross - functional teams in a multicultural environment to ensure reliable performance.
Senior IT Quality Assurance Lead overseeing QA processes for IT projects. Leading a team and ensuring quality throughout the project lifecycle in a dynamic environment.
Senior QA Analyst ensuring the accuracy, efficiency, and reliability of business process workflows across various platforms and systems in a global company.
Lead QA strategy and execution for complex enterprise applications. Defining testing approaches and mentoring junior QAs in an Agile environment.
QA Tester in Athens responsible for analyzing system specifications and conducting manual and automated tests. Collaborating with the QA team to ensure software quality and reliability.
Quality Engineer overseeing product quality assurance throughout its lifecycle in aeronautics and defense sectors. Involves project coordination and compliance management in a regulated environment.
QA Engineer focused on creating and executing test cases at Timestamp Group. Involves mobile applications, API testing, and teamwork in a Scrum setting.