Senior Quality Assurance Manager Medical Devices
2 weeks ago
Are you passionate about ensuring quality at every step and do you have a QA-mindset?
Ascendis Pharma is seeking a talented Senior Quality Assurance Manager Medical Devices to join our team.
About the Role
As a Senior Quality Assurance Manager Medical Devices, you will play a crucial role in our Quality Assurance team, responsible for establishing and maintaining quality management systems that ensure the highest standards of quality and compliance in our Medical Devices.
Key Responsibilities
- Develop and implement quality management systems and processes to ensure compliance with regulatory requirements.
- Conduct audits and assessments to identify areas for improvement and implement corrective actions.
- Collaborate with cross-functional teams to develop and implement quality-related procedures and processes.
- Provide guidance and support to colleagues on quality-related matters.
- Stay up-to-date with regulatory requirements and industry developments.
Requirements
- Masters degree in natural science or similar.
- Minimum 5 years of QA experience in life science.
- Experience with ISO13485:2016, MDSAP, 21CFR Part 820, 21CFR Part 4, ISO14971:2019, and ISO11608:2022.
- Strong analytical and problem-solving skills.
- Excellent communication and interpersonal skills.
About Ascendis Pharma
Ascendis Pharma is a fast-growing biopharmaceutical company with locations in Denmark, Germany, the United States, UK, Italy, Spain, and France. We are applying our TransCon technology to build a leading, fully integrated biopharmaceutical company focused on making a meaningful difference in patients' lives. Guided by our core values of patients, science, and passion, we use our TransCon drug development platform to fulfill our mission of developing new and potentially best-in-class therapies to address unmet medical needs.
Why Join Us?
At Ascendis Pharma, you will be part of an informal and innovative working environment where you will interact with colleagues, suppliers, and partners to deliver on Ascendis' ambitious corporate goals. You will be part of an expanding QA-organization supporting development, clinical, commercial, and launch activities.
Travel Requirements
5-10 days per year.
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