Senior QA Design Assurance Specialist – Glostrup position

Job Description

Are you experienced within design control of medical devices and interested in making a difference in cancer diagnostics worldwide?

At our site in Glostrup we develop and produce reagents, instruments and software for in vitro diagnostic of cancer, and we are currently looking for a Senior QA Design Assurance Specialist to work primarily in design and development projects but also to support with product sustain activities for our reagents, instruments and software.

In the role you will be responsible for ensuring compliance with Agilent’s QMS and external requirements, especially with regards to Design Control, including e.g. Risk Management, Change Control and V&V activities. You will also be responsible for driving initiatives to ensure continuous improvements of our processes as well as collaborating with international colleagues to achieve company goals.

You will partner with many stakeholders across the organization, covering but not limited to R&D, RA, Production and Marketing to ensure the right level of quality of documentation in all lifecycle phases of our products.

You will report to the Manager, Development QA.

To be successful in the role you must have excellent communication and collaboration skills and take pride in working with project teams to deliver high quality products and documentation at scheduled time. It is essential that you can proactively engage in identifying innovative and efficient solutions to critical/complex problems which meet both business needs and the right level of quality/compliance.

Qualifications

• Master’s degree in Biochemistry, Engineering or related field of study.
• Preferably +8 years of experience in development of In Vitro Diagnostics (IVD), Medical Devices and/or Pharmaceuticals.
• Experience within both reagents, hardware and software devices is preferred but not required.
• Thoroughly versed in Quality System Standards (ISO13485, FDA CFR21 Part 820, MDSAP) and IVD/Medical Devices legislation in EU and USA.
• Strong skills within design control and understanding of ISO14971, ISO62366, ISO62304.
• Strong analytical skills with focus on finding the right solutions in compliance with applicable regulations and QMS requirements.
• On a personal level, you are process and detail oriented as well as a proactive team player who’s capable of working cross-functionally with people at all levels of the organization.
• Full fluency in English on business level. Note that fluency in Danish is not required but preferable.

We Offer:

• An inspiring and social environment with around 40 skilled colleagues in the QA department providing QA support within development, manufacturing and sustain activities.  
• A great opportunity for you to make a significant impact and develop your skills in a world-class company that takes pride in developing new innovative solutions for the pathology labs around the world to improve cancer diagnostics.  
• A role among passionate colleagues, in a growth orientated and inclusive environment. You will become part of a caring and fast paced environment, built on integrity, sharing and trust.
• Agilent offers core global benefits to all staff - but in addition to these, the DK business offers Agilent Result Bonus, Stock Purchase Plan, Life Insurance, Pension, Healthcare, Physiotherapy and much more.

Travel Required

Schedule

Shift

Duration

Job Function

Location: Denmark-Glostrup

Senior QA Design Assurance Specialist – Glostrup position

Job Description

Are you experienced within design control of medical devices and interested in making a difference in cancer diagnostics worldwide?

At our site in Glostrup we develop and produce reagents, instruments and software for in vitro diagnostic of cancer, and we are currently looking for a Senior QA Design Assurance Specialist to work primarily in design and development projects but also to support with product sustain activities for our reagents, instruments and software.

In the role you will be responsible for ensuring compliance with Agilent’s QMS and external requirements, especially with regards to Design Control, including e.g. Risk Management, Change Control and V&V activities. You will also be responsible for driving initiatives to ensure continuous improvements of our processes as well as collaborating with international colleagues to achieve company goals.

You will partner with many stakeholders across the organization, covering but not limited to R&D, RA, Production and Marketing to ensure the right level of quality of documentation in all lifecycle phases of our products.

You will report to the Manager, Development QA.

To be successful in the role you must have excellent communication and collaboration skills and take pride in working with project teams to deliver high quality products and documentation at scheduled time. It is essential that you can proactively engage in identifying innovative and efficient solutions to critical/complex problems which meet both business needs and the right level of quality/compliance.

Qualifications

• Master’s degree in Biochemistry, Engineering or related field of study.
• Preferably +8 years of experience in development of In Vitro Diagnostics (IVD), Medical Devices and/or Pharmaceuticals.
• Experience within both reagents, hardware and software devices is preferred but not required.
• Thoroughly versed in Quality System Standards (ISO13485, FDA CFR21 Part 820, MDSAP) and IVD/Medical Devices legislation in EU and USA.
• Strong skills within design control and understanding of ISO14971, ISO62366, ISO62304.
• Strong analytical skills with focus on finding the right solutions in compliance with applicable regulations and QMS requirements.
• On a personal level, you are process and detail oriented as well as a proactive team player who’s capable of working cross-functionally with people at all levels of the organization.
• Full fluency in English on business level. Note that fluency in Danish is not required but preferable.

We Offer:

• An inspiring and social environment with around 40 skilled colleagues in the QA department providing QA support within development, manufacturing and sustain activities.  
• A great opportunity for you to make a significant impact and develop your skills in a world-class company that takes pride in developing new innovative solutions for the pathology labs around the world to improve cancer diagnostics.  
• A role among passionate colleagues, in a growth orientated and inclusive environment. You will become part of a caring and fast paced environment, built on integrity, sharing and trust.
• Agilent offers core global benefits to all staff - but in addition to these, the DK business offers Agilent Result Bonus, Stock Purchase Plan, Life Insurance, Pension, Healthcare, Physiotherapy and much more.

Travel Required

Schedule

Shift

Duration

Job Function

Location: Denmark-Glostrup