QA Specialist for Design Assurance, Instruments

Vor 6 Tagen

Hamburg, Deutschland Agilent Technologies Inc. Vollzeit

We are looking for an experienced QA Specialist for Design Assurance of our instruments to work within cross functional Instrument product development teams and sustaining the existing products in an international environment.

In this role you will represent Quality Assurance in design and development projects and product sustain activities ensuring compliance to Dako-s, a Agilent company quality management system and external requirements in general, especially with regards to Design Control, Risk Management, Change Control and Product Verification - Validation.

You will have a close collaboration with R-D, RA, Operation, Suppliers and Service to assure high quality throughout the development process. You will report to the Director Quality Engineering.

As a QA Instrument Specialist you will also be responsible for driving initiatives and changes to the current processes as well as collaborating with international colleagues to achieve company goals.

**Qualifications**:

- A background as Mechanical Engineer, Electronical Engineer or similar
- Strong experience working with development, sustain activities and Quality Assurance of IVD or Medical Devices minimum 5 years of experience.
- Experience working with ISO 13485, FDA CFR 21 Part 820 and ISO14971
- Experience working with non-conformities
- Proficiency in written and spoken English. Scandinavian languages is an advantage
- Strong analytical skills with focus on finding the right solutions in compliance with the regulations
- Capable of working cross-functionally with people at all levels of the organization.
- Good cross-cultural understanding.
- Flexible, detailed and engaged team player.

**We Offer**:

- An inspiring environment with 20 skilled colleagues in the QA R-D department in Glostrup. We take pride in developing new innovative solutions for the pathology labs around the world, in order to improve cancer diagnostics - and we constantly improve the quality.
- An opportunity for you to make a significant impact in a world-class company and develop your skills
- 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, Holiday, Physiotherapy and even an Art Club

We will make sure you get all the training and development opportunities you need **to become the best in your field**

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**: Occasional

**Schedule**: Schedule:Full time

**Shift**: Day

**Duration**: 0-3 Months

**Job Function**: Quality/Regulatory

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