QA IT Compliance Specialist
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QA IT Compliance Specialist– Corporate QA Systems, IT Compliance
Join us in shaping the future of Ambu Medical Devices
Are you passionate about quality and IT? Would you like to work in a global company where you can work across functions and on a wide variety of projects? Do you want to be a part of a global organization with high professional standards and a great working environment? Then we have an exciting job opportunity that may be your next career move.
We are looking for a QA IT Compliance Specialist, who can take up this position in the Corporate QA Systems, IT Compliance department. As a QA IT Compliance Specialist, you will be involved in several IT system projects and improvements governed primarily by Corporate IT. As we are a small team you will have great opportunities to engage with many different colleagues and build on your personal and professional development.
Ambu aspiration is to be the most customer-centric company in our field, to expand our leading position in single use endoscopy, anesthesia, and patient monitoring solutions. Our four strategic focus areas are providing innovative solutions for true customer needs, to excel in execution across the value chain, take leaps towards a sustainable future, bring people together in one shared culture.
A global job with impact
As QA IT Compliance Specialist, you will get a varied working day in a dynamic organization where you get to influence Ambu’s processes and IT Systems as well as your own daily tasks and responsibilities.
Your key responsibilities will be:
• Ensure compliance oversight – participate in project as IT QA responsible (both new projects and optimizations)
• Validation of IT Systems – review documentation, evaluate compliance and data integrity risk, approvals and monitoring, test guidance and training.
• QA on changes to IT systems - Perform QA review and approval of IT changes related to various Ambu Business IT Systems (GxP).
• IT Business Partner – act as a close contact and effective business partner with Corporate IT on quality topics, data integrity and Information Security.
• Optimizations – maintain and continuously improve QMS processes within Corporate QA Systems area of responsibility, including IT QMS processes pertaining to Corporate IT.
Experience and passion
To succeed in the job, you could have a relevant academic background - e.g. a MSc / BSc in engineering or similar. Having 2-4 years’ experience from working with compliance in IT systems within the regulated industry (Medical Device or Pharma) will be an advantage.
Key competences
• Flair for working in IT Systems as well as technical interest.
• Experience with, or interest in Compliance and/or QA support to IT projects and changes.
• Knowledge of regulatory requirements for Medical Devices and/or computerized systems validation e.g. ISO 13485, 21 CFR Part 11, GAMP5, Data Integrity, Information Security.
• If you have experience as an IT Auditor of IT suppliers, it will also be an advantage.
As a person, you are outgoing, open to learn, and you can work both in groups and independently. You take pride in good collaboration and focus on respectful dialogue with your colleagues. You are structured and good at prioritizing, planning, and finalizing your tasks. For all the key responsibilities you can establish good balance between business requirements and requirements from regulations.
Ambu promises
• The chance to actively help shape a paradigm shift in the healthcare market.
• An exciting job with innovative and groundbreaking medical device products.
• A pleasant working atmosphere where the customer is the focus of our work.
• A collegial, friendly, and dynamic working environment in a constantly growing company.
• Participation in an energetic team with short communication channels.
• Remuneration in line with the market and performance.
• Room for active personal and professional advancement.
Ambu – a visionary and international workplace where your efforts matter
As Ambu is a global company it is essential that you have excellent English skills and that you have a global mindset in relation to both co-workers and business opportunities.
We offer a wide range of professional, social, and financial employee benefits along with exciting job challenges and career opportunities contributing to your job satisfaction.
When to apply
As an equal opportunity employer, all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, or national origin. If you are ready to apply for the position, please apply as soon as possible. We will invite candidates for interviews on a continuous basis so no need to hesitate.
For further inquiries please contact Head of Corporate QA Systems, IT Compliance, Niels-Jørgen Svarrer, at [email protected]
Your application will be treated with confidentiality.
Join us in shaping the future of Ambu Medical Devices
Are you passionate about quality and IT? Would you like to work in a global company where you can work across functions and on a wide variety of projects? Do you want to be a part of a global organization with high professional standards and a great working environment? Then we have an exciting job opportunity that may be your next career move.
We are looking for a QA IT Compliance Specialist, who can take up this position in the Corporate QA Systems, IT Compliance department. As a QA IT Compliance Specialist, you will be involved in several IT system projects and improvements governed primarily by Corporate IT. As we are a small team you will have great opportunities to engage with many different colleagues and build on your personal and professional development.
Ambu aspiration is to be the most customer-centric company in our field, to expand our leading position in single use endoscopy, anesthesia, and patient monitoring solutions. Our four strategic focus areas are providing innovative solutions for true customer needs, to excel in execution across the value chain, take leaps towards a sustainable future, bring people together in one shared culture.
A global job with impact
As QA IT Compliance Specialist, you will get a varied working day in a dynamic organization where you get to influence Ambu’s processes and IT Systems as well as your own daily tasks and responsibilities.
Your key responsibilities will be:
• Ensure compliance oversight – participate in project as IT QA responsible (both new projects and optimizations)
• Validation of IT Systems – review documentation, evaluate compliance and data integrity risk, approvals and monitoring, test guidance and training.
• QA on changes to IT systems - Perform QA review and approval of IT changes related to various Ambu Business IT Systems (GxP).
• IT Business Partner – act as a close contact and effective business partner with Corporate IT on quality topics, data integrity and Information Security.
• Optimizations – maintain and continuously improve QMS processes within Corporate QA Systems area of responsibility, including IT QMS processes pertaining to Corporate IT.
Experience and passion
To succeed in the job, you could have a relevant academic background - e.g. a MSc / BSc in engineering or similar. Having 2-4 years’ experience from working with compliance in IT systems within the regulated industry (Medical Device or Pharma) will be an advantage.
Key competences
• Flair for working in IT Systems as well as technical interest.
• Experience with, or interest in Compliance and/or QA support to IT projects and changes.
• Knowledge of regulatory requirements for Medical Devices and/or computerized systems validation e.g. ISO 13485, 21 CFR Part 11, GAMP5, Data Integrity, Information Security.
• If you have experience as an IT Auditor of IT suppliers, it will also be an advantage.
As a person, you are outgoing, open to learn, and you can work both in groups and independently. You take pride in good collaboration and focus on respectful dialogue with your colleagues. You are structured and good at prioritizing, planning, and finalizing your tasks. For all the key responsibilities you can establish good balance between business requirements and requirements from regulations.
Ambu promises
• The chance to actively help shape a paradigm shift in the healthcare market.
• An exciting job with innovative and groundbreaking medical device products.
• A pleasant working atmosphere where the customer is the focus of our work.
• A collegial, friendly, and dynamic working environment in a constantly growing company.
• Participation in an energetic team with short communication channels.
• Remuneration in line with the market and performance.
• Room for active personal and professional advancement.
Ambu – a visionary and international workplace where your efforts matter
As Ambu is a global company it is essential that you have excellent English skills and that you have a global mindset in relation to both co-workers and business opportunities.
We offer a wide range of professional, social, and financial employee benefits along with exciting job challenges and career opportunities contributing to your job satisfaction.
When to apply
As an equal opportunity employer, all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, or national origin. If you are ready to apply for the position, please apply as soon as possible. We will invite candidates for interviews on a continuous basis so no need to hesitate.
For further inquiries please contact Head of Corporate QA Systems, IT Compliance, Niels-Jørgen Svarrer, at [email protected]
Your application will be treated with confidentiality.
Information og data
Denne ledige stilling har jobtypen "Øvrige", og befinder sig i kategorien "Øvrige stillinger".
Arbejdsstedet er beliggende i Ballerup.
Jobbet er oprettet på vores service den 14.3.2023, 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.
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