Senior Quality Assurance Engineer
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Ballerup
Are you passionate about quality and do you want to be part of a global organization with high professional standards working to shape the future of medical devices? Do you want to be part establishing a new manufacturing site in Mexico? Then we have an exciting job opportunity that may be your next career move.
We are looking for a Senior Quality Assurance engineer who will set the direction for the Quality Assurance of Ambu products from a corporate perspective in close collaboration with Ambu manufacturing sites in Malaysia, China, USA and at a new manufacturing site in Mexico. In this role you will be actively involved in QA activities for establishing the new Ambu manufacturing site in Mexico.
You will be part of a strong quality culture, where we keep ahead of new regulatory requirements and constantly strive for improvements. You will work from our Headquarters in Ballerup, Denmark and join a Corporate Quality Engineering unit where you will refer to the Director for Corporate Quality Engineering.
A global job with impact
As Senior Quality Assurance Engineer, you will get a varied working day in a dynamic organization where you get to influence Ambu’s marketed products as well as your own daily tasks and responsibilities.
Your key responsibilities will be to:
• You will be involved and driving QA activities for establishing new Ambu manufacturing site in Mexico.
• Be person responsible for regulatory compliance for release of Ambu products worldwide. This includes to keep oversight of the release process for Ambu’s four manufacturing sites. You will also be process owner for the release process and provide technical support to local site Release officers.
• You will take leadership in setting direction and define collaboration in relation to contract manufacturing and outsourced processes and take lead in ensuring clear procedures.
• Continuously develop the Quality Assurance Engineering area, including ensuring efficient QMS processes within your own area of responsibility
You will be part of a cross-functional team, and you will be working closely together with stakeholders from Regulatory Affairs, R&D, Marketing, Clinical Department and Ambu manufacturing sites.
Experience with Quality Assurance
To succeed in the job, you need to have at least 5+ years of experience within the Quality Assurance and preferable QC work including handling of product/material specifications, release test, sampling requirements, nonconformities, CAPA and COA/COC release within Medical Device industry.
Furthermore, you have detailed knowledge and experience with ISO13485, 21CRF820 and EU MDR 2017/745. You might have worked with contract manufactures/outsourced production and demonstrated experience from working with manufacturing of medical devices.
You have excellent communication skills, and you can take lead of cross-functional tasks. You have experience with working in a high paced environment and you are not afraid to take responsibility. Your business understanding makes you able to translate regulatory and quality requirements into effective business processes.
Ambu is a global company and English is our corporate language, which requires that you speak and write English at a high level. You will use English every day in your job.
How to apply
If you are ready to apply for the position, please apply as soon as possible. Note that we will invite candidates for interviews on a continuous basis so no need to hesitate. This job ad might be online until 17th September, but once we have found the right candidate, this ad will no longer be online.
If you have any questions about the position, you can contact Karsten Randrup Kragh, Director Corporate Quality Engineering, by phone +45 22478305. Your application will be treated with confidentiality.
We are looking for a Senior Quality Assurance engineer who will set the direction for the Quality Assurance of Ambu products from a corporate perspective in close collaboration with Ambu manufacturing sites in Malaysia, China, USA and at a new manufacturing site in Mexico. In this role you will be actively involved in QA activities for establishing the new Ambu manufacturing site in Mexico.
You will be part of a strong quality culture, where we keep ahead of new regulatory requirements and constantly strive for improvements. You will work from our Headquarters in Ballerup, Denmark and join a Corporate Quality Engineering unit where you will refer to the Director for Corporate Quality Engineering.
A global job with impact
As Senior Quality Assurance Engineer, you will get a varied working day in a dynamic organization where you get to influence Ambu’s marketed products as well as your own daily tasks and responsibilities.
Your key responsibilities will be to:
• You will be involved and driving QA activities for establishing new Ambu manufacturing site in Mexico.
• Be person responsible for regulatory compliance for release of Ambu products worldwide. This includes to keep oversight of the release process for Ambu’s four manufacturing sites. You will also be process owner for the release process and provide technical support to local site Release officers.
• You will take leadership in setting direction and define collaboration in relation to contract manufacturing and outsourced processes and take lead in ensuring clear procedures.
• Continuously develop the Quality Assurance Engineering area, including ensuring efficient QMS processes within your own area of responsibility
You will be part of a cross-functional team, and you will be working closely together with stakeholders from Regulatory Affairs, R&D, Marketing, Clinical Department and Ambu manufacturing sites.
Experience with Quality Assurance
To succeed in the job, you need to have at least 5+ years of experience within the Quality Assurance and preferable QC work including handling of product/material specifications, release test, sampling requirements, nonconformities, CAPA and COA/COC release within Medical Device industry.
Furthermore, you have detailed knowledge and experience with ISO13485, 21CRF820 and EU MDR 2017/745. You might have worked with contract manufactures/outsourced production and demonstrated experience from working with manufacturing of medical devices.
You have excellent communication skills, and you can take lead of cross-functional tasks. You have experience with working in a high paced environment and you are not afraid to take responsibility. Your business understanding makes you able to translate regulatory and quality requirements into effective business processes.
Ambu is a global company and English is our corporate language, which requires that you speak and write English at a high level. You will use English every day in your job.
How to apply
If you are ready to apply for the position, please apply as soon as possible. Note that we will invite candidates for interviews on a continuous basis so no need to hesitate. This job ad might be online until 17th September, but once we have found the right candidate, this ad will no longer be online.
If you have any questions about the position, you can contact Karsten Randrup Kragh, Director Corporate Quality Engineering, by phone +45 22478305. Your application will be treated with confidentiality.
Information og data
Denne ledige stilling har jobtypen "Produktchef", og befinder sig i kategorien "Ledelse og personale".
Arbejdsstedet er beliggende i Ballerup.
Jobbet er oprettet på vores service den 25.8.2021, men kan have været deaktiveret og genaktiveret igen.
Dagligt opdateret: Dette job opdateres dagligt ud fra jobudbyderens hjemmeside via vores søgemaskineteknologi og er aktivt lige nu.
- Produktchef
- Ballerup
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