Senior Quality Assurance Engineer
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Ballerup
Have you set your mind on working for a global company where you can work across functions and on a wide variety of projects? As a member of our QAE Compliance and SQM team, that is exactly what we are having in store for you!
As our new Senior Quality Assurance Engineer, you will drive multiple projects within our QA organization - for the continued improvement of corporate QA processes and for timely delivery according to strategic initiatives. In this role you will support the Corporate QA organization to reach optimal performance and in meeting multiple global business goals.
Our purpose is together, we rethink solutions to save lives and improve patient care.
Our 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.
You will be a trusted partner, provide insights, and support decision making, to drive business performance. The role is hybrid, and you will be based at our Headquarters in Ballerup, where you will be reporting directly to the Head of QAE Compliance & SQM. You will be warmly welcomed by our current QA / RA Team, consisting of 9 other brilliant minds and diverse personalities.
Your Responsibilities.
• Scoping and driving projects within QA/RA organization for the overall improvement of the Quality System Performance within Process responsibilities.
• Develop and monitor QA processes together with process owners and according to internal and external requirements.
• Participate in internal audits and inspections by external authorities. Prepare material and present during audit/inspection.
• Support and contribute to operational QA activities, for example NCR, CAPA, Post Market Surveillance.
• Support other project activities within Corp. QAE's area of responsibility.
Typical tasks will be to:
• Monitor improvement initiatives and objectives
• Implementing procedures and overseeing the QA process.
• Troubleshooting quality issues and modifying procedures.
• Kickstarting and driving multiple projects.
Your Background.
You have successfully completed a Bachelor or Master of Science in (Bio)Medical Engineering, Electrical Engineering or any related discipline. You have 2+ years of relevant professional experience in quality assurance or product development within a regulated industry, ideally in medical devices. But we welcome experience from other industries as well.
Furthermore, you have a sound understanding of project management, are equipped with a solid project management toolbox and even have relevant project management experience. A big plus would be experience with BI tool and / or medical device regulation (MDR) and standards.
You are characterized by an outgoing personality, a high level of communication and analytical skills as well as a quality first mindset. Your fluent English skills enable you to interact easily in an innovative and international environment.
Our promise.
• 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.
Additional company information.
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.
For further inquiries please contact the Head of QAE Compliance & SQM, Anne Kofod Boel on
+45 72 25 22 19
Your application will be treated confidentially.
As our new Senior Quality Assurance Engineer, you will drive multiple projects within our QA organization - for the continued improvement of corporate QA processes and for timely delivery according to strategic initiatives. In this role you will support the Corporate QA organization to reach optimal performance and in meeting multiple global business goals.
Our purpose is together, we rethink solutions to save lives and improve patient care.
Our 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.
You will be a trusted partner, provide insights, and support decision making, to drive business performance. The role is hybrid, and you will be based at our Headquarters in Ballerup, where you will be reporting directly to the Head of QAE Compliance & SQM. You will be warmly welcomed by our current QA / RA Team, consisting of 9 other brilliant minds and diverse personalities.
Your Responsibilities.
• Scoping and driving projects within QA/RA organization for the overall improvement of the Quality System Performance within Process responsibilities.
• Develop and monitor QA processes together with process owners and according to internal and external requirements.
• Participate in internal audits and inspections by external authorities. Prepare material and present during audit/inspection.
• Support and contribute to operational QA activities, for example NCR, CAPA, Post Market Surveillance.
• Support other project activities within Corp. QAE's area of responsibility.
Typical tasks will be to:
• Monitor improvement initiatives and objectives
• Implementing procedures and overseeing the QA process.
• Troubleshooting quality issues and modifying procedures.
• Kickstarting and driving multiple projects.
Your Background.
- Experience with project management medical devices,
- Experience within Quality assurance for medical devices, EU MDR, ISO 13485, 21CFRPart 820
- Structured, Good overview, Personal drive, collaboration
- QA skills is an advantage, familiar with CAPA, NCR, Supplier Control, Audit etc.
You have successfully completed a Bachelor or Master of Science in (Bio)Medical Engineering, Electrical Engineering or any related discipline. You have 2+ years of relevant professional experience in quality assurance or product development within a regulated industry, ideally in medical devices. But we welcome experience from other industries as well.
Furthermore, you have a sound understanding of project management, are equipped with a solid project management toolbox and even have relevant project management experience. A big plus would be experience with BI tool and / or medical device regulation (MDR) and standards.
You are characterized by an outgoing personality, a high level of communication and analytical skills as well as a quality first mindset. Your fluent English skills enable you to interact easily in an innovative and international environment.
Our promise.
• 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.
Additional company information.
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.
For further inquiries please contact the Head of QAE Compliance & SQM, Anne Kofod Boel on
+45 72 25 22 19
Your application will be treated confidentially.
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 20.2.2023, 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.
- Produktchef
- Ballerup
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