QA Design Assurance Specialist
20 hours ago
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 QA Design Assurance Specialist to represent QA in design control activities for our reagents, instruments and software.
The QA Design Assurance Specialist will be responsible for ensuring compliance with internal and external requirements during design and development of new products, especially with regards to design control, including e.g. requirements, risk management, V&V activities and change control.
The QA Design Assurance Specialist will represent QA on various project teams and partner with local/international stakeholders across the organization, covering but not limited to R&D, RA, Production and Marketing. The focus will be to:
- Provide guidance on design control activities to identify innovative and efficient solutions for various quality topics which meet both business needs and the right level of quality.
- Conduct reviews and approvals of design control documents, design changes, nonconformances, CAPAs.
- Drive quality initiatives to support continuous improvements of our processes.
Additional responsibilities may include:
- Product investigation support
- Support of internal and external audits
- Support for regulatory submissions and filings
- May initiate and support Quality Management Systems (QMS) improvements within area of responsibility
- Provide expertise, guidance and training within area of responsibility to the organization
The QA Design Assurance Specialist will report to the Manager, Development QA.
Qualifications- Master’s degree in biotechnology, Engineering or related field of study.
- Preferably +4 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.
- Proficient in Quality System Standards (ISO13485, FDA CFR21 Part 820, MDSAP) and IVD/Medical Devices legislation in EU and USA.
- Business oriented and a desire to work in a dynamic and adaptable environment.
- Strong analytical skills with focus on finding the right solutions in compliance with the regulations.
- Excellent communication and collaboration skills.
- Ability to make independent decisions/complete tasks within the framework and guidelines of the organization at scheduled time.
- 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 product quality activities.
- 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.
- 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.
- 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.
This job has a full time weekly schedule. Our pay ranges are determined by role, level, and location. Within the range, individual pay is determined by work location and additional factors, including job-related skills, experience, and relevant education or training. During the hiring process, a recruiter can share more about the specific pay range for a preferred location. Pay and benefit information by country are available at: Agilent Careers . Agilent Technologies Inc. is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other protected categories under all applicable laws.
Travel Required:No
Shift:Day
Duration:No End Date
Job Function:Quality/Regulatory
#J-18808-Ljbffr-
QA Design Assurance Specialist
6 days ago
Glostrup, Denmark Agilent Full timeDescription 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 QA Design Assurance Specialist to represent QA in design...
-
Glostrup, Glostrup Kommune, Denmark Agilent Full timeJob DescriptionWe are seeking a highly skilled QA Design Assurance Specialist to join our team in Glostrup, Denmark.The successful candidate will be responsible for ensuring compliance with internal and external requirements during design and development of new products, particularly in design control, risk management, V&V activities, and change...
-
Glostrup, Glostrup Kommune, Denmark Agilent Full timeAt Agilent, we are seeking a Product Assurance Specialist to join our QA team in Glostrup. This role will be responsible for ensuring compliance with internal and external requirements during design and development of new products, especially with regards to design control.The ideal candidate will have a Master's degree in biotechnology, Engineering or...
-
Gentofte Kommune, Denmark ASCENDIS PHARMA AS Full timePassionate about Quality Assurance with expertise within outsourced GMP activities and development projects? Ascendis Pharma invites you to explore the role of our newest QA Specialist / QA Professional for Development GMP activities. With roots spanning Denmark, Germany, and the United States, Ascendis Pharma A/S emerges as an innovative and dynamic...
-
Manufacturing Quality Assurance Specialist
4 weeks ago
Glostrup, Glostrup Kommune, Denmark Agilent Full timeAbout the RoleAgilent is seeking a skilled Manufacturing Quality Assurance Specialist to join our team. As a key member of our QA department, you will be responsible for ensuring the quality and compliance of our manufacturing processes.Key Responsibilities:Apply advanced Quality Engineering/Scientific Method techniques and principles to daily tasks and...
-
Senior QA Specialist
4 weeks ago
Glostrup, Glostrup Kommune, Denmark Black Swans Exist ApS Full timeAbout the Role: As a Senior QA Specialist, you will be responsible for supporting small biotech and pharmaceutical companies in crafting innovative new products. You will also architect and refine Quality Management Systems for emerging pharmaceutical firms. Additionally, you will serve as a QA specialist for the GCP/GMP site in Glostrup and conduct audits...
-
Advanced QA Professional
2 months ago
Herlev Kommune, Denmark Nordic Bioscience Full timeAre you looking for a chance to use your solid QA experience in a dynamic and growing company? Do you want a unique position with broad responsibilities and high impact in a highly professional environment? And are you passionate about quality assurance, possess a keen eye for detail, and thrive in a collaborative environment? Then please read on. Diverse...
-
Glostrup, Glostrup Kommune, Denmark Black Swans Exist ApS Full timeAbout the Role: We are seeking a skilled Senior QA Specialist to join our team at Black Swans Exist ApS, a leading international drug development consultancy. About the Job: As a Senior QA Specialist, you will be responsible for supporting small biotech and pharmaceutical companies in crafting innovative new products. You will architect and refine Quality...
-
Senior Quality Assurance Specialist
1 month ago
Glostrup, Glostrup Kommune, Denmark Black Swans Exist ApS Full timeAbout the Role:We are seeking a highly skilled Senior QA Specialist to join our team at Black Swans Exist ApS. As a Senior QA Specialist, you will play a critical role in supporting small biotech and pharmaceutical companies in crafting innovative new products.Your Key Responsibilities:Architect and refine Quality Management Systems for emerging...
-
Validation Quality Assurance Engineer
6 days ago
Glostrup, Glostrup Kommune, Denmark Agilent Technologies, Inc. Full timeAgilent Technologies, Inc. Job DescriptionWe are seeking a highly skilled Validation Quality Assurance Engineer - Production Support Specialist to join our team in Glostrup.About the RoleThis is a challenging opportunity for you to lead all aspects of validation activities at our manufacturing site. As a key member of our production support team, you will be...
-
Manufacturing Quality Assurance Specialist
1 month ago
Glostrup, Glostrup Kommune, Denmark Agilent Full timeJob DescriptionAgilent is seeking a highly skilled Manufacturing QA Specialist to join our team. As a key member of our QA department, you will play a critical role in ensuring the quality and compliance of our products.Key Responsibilities:Apply advanced Quality Engineering and Scientific Method techniques to daily tasks and activities.Make decisions on...
-
Software/Hardware Design Control Specialist
4 weeks ago
Glostrup, Glostrup Kommune, Denmark Agilent Technologies Full timeJob Title: Software/Hardware Design Control SpecialistAgilent inspires and supports discoveries that advance the quality of life. We provide life science, diagnostic and applied market laboratories worldwide with instruments, services, consumables, applications and expertise. Agilent enables customers to gain the answers and insights they seek, so they can...
-
QA Specialist
2 months ago
Gladsaxe Kommune, Denmark Novo Nordisk AS Full timeJobbeskrivelse Placering Bagsværd, Denmark Jobkategori Quality Ansøg nu We are looking for a skilled QA specialist, to take part in a strong, evolving, and fast-moving organisation with a significant role in securing the quality and safety of Novo Nordisk's products. Does this sound like a job for you? Then you may be the person we are looking for to...
-
Software/Hardware Design Control Specialist
2 months ago
Glostrup Kommune, Denmark Agilent Technologies Full timeJob Description Agilent inspires and supports discoveries that advance the quality of life. We provide life science, diagnostic and applied market laboratories worldwide with instruments, services, consumables, applications and expertise. Agilent enables customers to gain the answers and insights they seek, so they can do what they do best: improve the world...
-
Glostrup, Glostrup Kommune, Denmark Agilent Full timeAgilent inspires and supports discoveries that advance the quality of life. We provide life science, diagnostic and applied market laboratories worldwide with instruments, services, consumables, applications and expertise.We are seeking a skilled Manufacturing QA Specialist to join our team in developing innovative solutions for pathology labs worldwide to...
-
Senior QA Engineer
2 months ago
Herlev Kommune, Denmark Secomea Full timeWant to ensure the quality of our secure remote access management platform that enables companies to connect, monitor, and optimize industrial machines from anywhere around the globe? Apply now We’re looking for a team-oriented Senior Quality Assurance Engineer who thrives in a rapidly growing environment. You will play a crucial role in securing the...
-
Software Design Control
3 weeks ago
Glostrup, Denmark Agilent Full timeDescription Agilent inspires and supports discoveries that advance the quality of life. We provide life science, diagnostic and applied market laboratories worldwide with instruments, services, consumables, applications and expertise. Agilent enables customers to gain the answers and insights they seek, so they can do what they do best: improve the...
-
Associate Principal Scientist, Quality Assurance
2 months ago
Gladsaxe Kommune, Denmark AGC Biologics Full timeOur purpose is to bring hope to life by enabling life-changing therapies for patients around the globe, creating a healthier and happier tomorrow. Our mission is to work side by side with our customers in order to improve patients’ lives by bringing new biopharmaceuticals to market. AGC Biologics is looking for an experienced QA scientist to assist with...
-
IT Design Control Specialist
3 hours ago
Glostrup, Glostrup Kommune, Denmark Agilent Technologies Full timeJob OverviewWe are seeking a highly skilled IT Design Control Specialist to join our team in Denmark. As an IT Design Control Specialist, you will be responsible for planning, specification, development, test, release, and documentation of IT accessories used with our medical devices and IVD products.This is a temporary contract of 2 years (with the...
-
Senior Scientist, Quality Assurance
2 months ago
Gladsaxe Kommune, Denmark AGC Biologics Full timeOur purpose is to bring hope to life by enabling life-changing therapies for patients around the globe, creating a healthier and happier tomorrow. Our mission is to work side by side with our customers in order to improve patients’ lives by bringing new biopharmaceuticals to market. Would you like to be a part of AGC Biologics' growing success? We are...
