Quality Support 3
Business Unit: Laboratory Diagnostics
Requisition Number: 231862
Primary Location: United States-New Jersey-Flanders
Assignment Category: Full-time regular
Experience Level: Mid level
Education Required Level: High School Diploma / (GED)
Travel Required: 5%
At Siemens Healthineers, we are passionate about enabling healthcare professionals to deliver high quality patient care, and to do so affordably. A leading global healthcare company, Siemens Healthineers continues to strengthen our portfolio of medical imaging and laboratory diagnostics, while adding new offerings such as managed services, consulting, and healthcare IT services – as well as further technologies in the growing market for therapeutic and molecular diagnostics.
Siemens Healthineers develops innovations that support better patient outcomes with greater efficiencies, giving providers the confidence they need to meet the clinical, operational and financial challenges of a changing healthcare landscape.
This position is for a Document Control Coordinator. This person will work with all departments on site to organize to organize and ensure compliance of documents in all relevant systems.
The person in this role will:
- Ensure procedures, work instructions, device history records, inspection plans etc., are reviewed, and stored into the relative quality system databases in a controlled and compliant manner.
- Coordinate and ensure periodic reviews are performed on time.
- Enable compliance to the document control portions of the relevant ISO and QSR regulations.
- Support the Flanders site training process and system
This position will be responsible for the control of documentation across the supply chain management portion of the site.
- Drive document creation and revision review, approvals and effectivity in a compliant and timely manner.
- Work cross functionally to assist the site in the document control needs
- Ensure accuracy of documents including revisions, procedure and form numbers and second checks to change control documentation.
Required Knowledge/Skills, Education, and Experience
- Strong organizational skills and ability to prioritize
- Detail oriented
- Experience working in medical device or regulated industry
- Proficient with Microsoft Word and Excel
- Ability to communicate effectively within a technical environment
- Experience working with electronic databases, specifically SAP
Preferred Knowledge/Skills, Education, and Experience
Prior Experience in a medical device/biotech industry required. Preferrably, 5-8 years of successful experience in document control/quality systems.
High School Associates or equivalent, required.
Technical degree with coursework in engineering preferred, but not required.