Agilent Technologies, Inc. QMS Engineer – PLC / Design Control Specialist (m/f) in Germany


Agilent Technologies – we stand for high-tech and laboratory expertise around the world. As a worldwide company based in Santa Clara (California/USA), in the heart of Silicon Valley, we offer instruments, software, services and supplies for the entire workflow in the analytical laboratory. Our solutions and products are used among other things for the development of new drugs, for food testing, in cancer research and in doping control. We inspire discoveries that advance the quality of life.

To strengthen our team, we are looking for a Product Quality Management System (QMS) Engineer (m/f) for our international Quality Systems team in the Life Sciences and Applied Markets Group (LSAG).

Your responsibilities:

  • Manage our product development lifecycle (PLC) process and support our product development teams in all aspects of design control

  • Work closely with the QMS representatives, quality teams and all business functions around the world involved in the new product introduction (NPI) process to make sure our design control processes are efficient, effective and meet all applicable regulations

  • Provide guidance, training, consulting and hands-on support, as well as the continuous improvement of our process environment


Your qualifications:

  • Bachelor’s, Master’s or University Degree or equivalent in Engineering or Scientific/Technical discipline

  • Minimum 4 years relevant experience

  • Preferably advanced knowledge and/or certifications of QMS standards (e.g. auditor qualification)

  • Profound knowledge of design control requirements in ISO 9001, ISO 13485, ISO 14971 and medical device regulations (QSR, IVD directive)

  • Familiar with lifecycle standards such as ISO 12207, IEC 62304

  • Good understanding and practical experience of requirements management, design verification and validation

  • Active participation in product development projects, preferably as part of different functions (R&D;, manufacturing, quality, marketing, product support)

  • Preferably profound knowledge of data management and collaboration systems

  • Preferably practical experience in six sigma and/or statistics

  • Demonstrates strong teamwork skills and is able to lead, collaborate and work effectively in teams across different businesses, functions and geographies

  • Be sensitive to work with people having different cultural background

  • Good communication skills (oral, written and presentation)

  • Willingness to work globally within different time zones

We offer:

  • Company pension scheme

  • Work-Life-Balance programs

  • Career development opportunities

Date Posted: 05/Dec/16

Requisition: 2069067

Job Title: QMS Engineer – PLC / Design Control Specialist (m/f)

Company: Agilent

Business: Life Sciences and Applied Markets Group

Job Category: Quality/Regulatory

Job Sub-Category: Quality

Region: Americas Europe

Country or Area: United States Germany

State/Province: California Delaware Baden Württemberg

Town/City: Waldbronn Santa Clara Wilmington

Shift: Day Job

Job Type: Experienced

Schedule: Full-time

Travel Required: Yes, 10% of the Time

Duration (Temp Positions Only): Not applicable