Senior QA Engineer
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Kongens Lyngby
PharmaRelations is the Nordic market leader within talent services for the life science industry. We specialise in partnering with some of the top and most innovative organisations exclusively in the Life Science sector across our region. We add value to our clients and candidates with our consultancy services, outsourcing solutions and recruitment of specialists and leaders.
We are currently partnering with BK Medical, an innovative ultrasound medical device company looking to recruit a Senior Quality Assurance Engineer (QAE) to join their internal team in Copenhagen.
As a Senior Quality Assurance Engineer, you have a solid understanding of the quality requirements for medical devices and feel comfortable in coaching and advising colleagues on Quality related aspects. You will participate in technical complex and cross-functional projects, where your Quality input and knowledge is adding value to the business. You have a solid understanding of design control, a robust design transfer process and risk management according to ISO 14971. You are used to working in an international setting, in a profound engineering setting and a dynamic environment, where your expertise within Quality and design control is crucial. You will be the go-to person and assist in ensuring structure, that processes are followed and the integration of design control and risk management in R&D projects.
Key responsibilities include:
The Senior Quality Assurance Engineer for BK Medical will be a vital person within the Global RA & QA team working in close cooperation with RA, Marketing and R&D. You thrive with responsibility and have the courage to implement and influence processes to the better. Taking on the task as Senior Quality Assurance Engineer requires not only a high level of engineering and technical understanding, but also a good portion of social skills and humour - it should not be the first time you work with complex innovative medical device products.
Requirements:
Why?
BK Medical has a unique technology within ultrasound and few competitors in the market. Driven by an expansive strategy BK Medical is expanding into new and exciting business areas using the newest technologies – from AI, Robotics and machine learning. BK Medical has a global footprint with 650 employees in USA and close to 200 employees in DK - representing the full value chain- from Development – Production and Sales.
How?
For further information do reach out to Head of Recruitment Ida Wenger-Parving on 2633 4301 or apply directly here. Due to GDPR, we cannot receive any CVs via e-mail. Interviews are already taking place, so please get in touch or apply at your earliest convenience.
At PharmaRelations we are committed to being an employer of equal opportunities for all and recruitment practices shall be free from discrimination based on race, color, ancestry, national origin, ethnic group identification, age. Religion, material or parental status, physical or mental disability, sex, sexual orientation, gender, gender identification or expression, or geneticinformation; the perception of one or more of such characteristics; or associated with a person or group with one or more of these actual or perceived characteristics.
We are currently partnering with BK Medical, an innovative ultrasound medical device company looking to recruit a Senior Quality Assurance Engineer (QAE) to join their internal team in Copenhagen.
As a Senior Quality Assurance Engineer, you have a solid understanding of the quality requirements for medical devices and feel comfortable in coaching and advising colleagues on Quality related aspects. You will participate in technical complex and cross-functional projects, where your Quality input and knowledge is adding value to the business. You have a solid understanding of design control, a robust design transfer process and risk management according to ISO 14971. You are used to working in an international setting, in a profound engineering setting and a dynamic environment, where your expertise within Quality and design control is crucial. You will be the go-to person and assist in ensuring structure, that processes are followed and the integration of design control and risk management in R&D projects.
Key responsibilities include:
The Senior Quality Assurance Engineer for BK Medical will be a vital person within the Global RA & QA team working in close cooperation with RA, Marketing and R&D. You thrive with responsibility and have the courage to implement and influence processes to the better. Taking on the task as Senior Quality Assurance Engineer requires not only a high level of engineering and technical understanding, but also a good portion of social skills and humour - it should not be the first time you work with complex innovative medical device products.
Requirements:
- Master’s or bachelor’s degree in engineering or related
- Solid experience with QA engineering including documentation, validation & risk management.
- Strong understanding of R&D processes for medical devices.
- Proven track record of reviewing USR, SRS, risk management files, UEF and V&V
- + 5 years’ experience from a similar role in the medical device industry
- Detail oriented and structure
- Driven and positive personality
- Pragmatic and systematic
- Used to work in an international environment
Why?
BK Medical has a unique technology within ultrasound and few competitors in the market. Driven by an expansive strategy BK Medical is expanding into new and exciting business areas using the newest technologies – from AI, Robotics and machine learning. BK Medical has a global footprint with 650 employees in USA and close to 200 employees in DK - representing the full value chain- from Development – Production and Sales.
How?
For further information do reach out to Head of Recruitment Ida Wenger-Parving on 2633 4301 or apply directly here. Due to GDPR, we cannot receive any CVs via e-mail. Interviews are already taking place, so please get in touch or apply at your earliest convenience.
At PharmaRelations we are committed to being an employer of equal opportunities for all and recruitment practices shall be free from discrimination based on race, color, ancestry, national origin, ethnic group identification, age. Religion, material or parental status, physical or mental disability, sex, sexual orientation, gender, gender identification or expression, or geneticinformation; the perception of one or more of such characteristics; or associated with a person or group with one or more of these actual or perceived characteristics.
Information og data
Denne ledige stilling har jobtypen "Øvrige", og befinder sig i kategorien "Øvrige stillinger".
Arbejdsstedet er beliggende i Kongens Lyngby.
Jobbet er oprettet på vores service den 9.11.2021, 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.
- Øvrige
- Kongens Lyngby
- Mandag den 31. januar 2022
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