Change Control & Data Specialist (Medical Devices)

Dexian

Kalamazoo (MI)

On-site

USD 70,000 - 110,000

Full time

2 days ago
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Job summary

Dexian is seeking a Specialist in Kalamazoo, MI to collect, retrieve, and validate product and material compliance data and to manage ECNs and change control documents. The role requires collaboration with Engineering, Quality, and Supply Chain to ensure accurate records and regulatory compliance.

Knowledge of PLM systems like Windchill and strong analytical skills are essential. The position is with a leading Talent + Technology firm offering global reach and a strong focus on compliance in the

Qualifications

  • Bachelor's degree in engineering or related field.
  • Experience in data collection, cleansing, and validation.
  • Knowledge of PLM systems, preferably PTC Windchill.
  • Experience with change management and compliance documentation.
  • Strong analytical and cross-functional communication skills.

Responsibilities

  • Collect, retrieve, and validate product and material compliance data.
  • Manage engineering change notices (ECNs) and change control documentation.
  • Coordinate with Engineering, Quality, Supply Chain, and suppliers.
  • Identify data gaps and maintain accurate compliance records.
  • Support environmental regulations such as REACH, RoHS, and PFAS.

Skills

Data collection
Data cleansing
Validation
Cross-functional communication
Analytical thinking
Change control

Education

Bachelor's degree in engineering or related field

Tools

PTC Windchill

Job description

Dexian is seeking a Specialist in Kalamazoo, MI to collect, retrieve, and validate product and material compliance data and to manage ECNs and change control documents. The role requires collaboration with Engineering, Quality, and Supply Chain to ensure accurate records and regulatory compliance.

Knowledge of PLM systems like Windchill and strong analytical skills are essential. The position is with a leading Talent + Technology firm offering global reach and a strong focus on compliance in the

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