
Manager, Quality Process Engineering – Denmark
Full time @H1B1 Recruiting posted 5 years ago in Engineering Shortlist Email JobJob Detail
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Job ID 5695
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Career Level Staff
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Experience 5 Years
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Gender Any
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Industry Engineering
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Qualifications Bachelor's Degree
Job Description
The primary responsibilities:
- Be a great manager for your employees, and ensure coaching, mentoring and development where needed
- Support to CAPA´s
- Drive the assigned validation activities in collaboration with Manufacturing
- Support the internal trainings in relation to validations
- Re-qualification/re-validation activities on current production processes and related documentation
- Give input to improvement of procedures for validation to fulfil internal and external requirements, ensuring validation documentation content meets the current regulatory requirements
- Ensure full focus on delivery to internal stakeholders according to plans.
- Ensure relevant support for Compliance and projects.
- Take active part in the Quality Engineering Management Group, consisting of 3 managers.
- Secure good collaboration between relevant stakeholders across the organization.
- Continue and cultivate the team culture, based on the living up to the Agilent values of Speed, Focus, Accountability, Innovation & Contribution, Trust, Respect & Teamwork, and finally Uncompromising integrity.
Your qualifications:
We expect that you have management experience within people and/or project management. Furthermore, a relevant educational background combined with experience from the areas listed below:Relevant work experience within CAPA, Validation, Risk Management, Change control and process monitoring
- +5 years of experience working with Quality Assurance of InVitro Diagnostic, Medical Devices and/or Pharmaceutical
- Experience working with ISO 13485, FDA CFR 21 Part 820 and ISO14971
- Proficiency in written and spoken English. Scandinavian languages are an advantage
- Strong analytical skills with focus on finding the right solutions in compliance with the regulations
- Flexible, systematic and engaged team player
- Robust with a sense of urgency combined with a good sense of humour
Questions:
If you have any questions to the position – please contact Hiring Manager Brian Langkjær Jensen on +45 5167 6381 or Recruitment Partner Tinne Bigum on +45 2933 6930 (except week 23).
Application:
We will review applications continuously so please send us your CV and cover letter as soon as possible via our recruitment system. We are looking forward to hearing from you.
About Agilent:
Agilent inspires and supports discoveries that advance the quality of life. We provide life science, diagnostic and chemical 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 around us. Information about Agilent is available at www.agilent.com.