Technical Administrative Assistant, Temporary (6-12 mos.) Contact: 1 st shift – Salary: $15-$16/hour Job Description:
The Quality Systems Specialist/Technical Administrative Assistant is responsible for assisting the quality team in many areas, such as providing feedback to production and others on good quality documentation practices, performing training when required, participating in quality audits both internal and external, and in providing back up to complaint handling as well as handling a subset of complaints.
1. Responsible for managing complaints associated with the site’s products. Complaints will be investigated, trended and corrective actions are taken where required.
2. Responsible for the solicitation of information from customers, account reps, clinicians and
others as necessary to ensure complaints are fully investigated.
3. Responsible for reviewing product device history records and releasing product.
4. Responsible for participating in the internal audit program and works with departmental
personnel to resolve audit findings
5. Responsible for the preparation of various reports and charts for the Quality Systems staff
meetings and Management Review meetings
6. Additional tasks as assigned include but are not limited to; Administrator for training software program; participation as an internal auditor, manage service escalation report process to assure applicable parties are involved; and any other task required or assigned by the Quality Systems Manager.
Job Requirements:
Associate degree required. Bachelor’s degree preferred. Professional certifications (e.g. ASQ CQA, RAC) desired.
Prefer 2-5 years in a regulated environment in the quality department or other technical department to include experience in manufacturing operations, document control, complaint handling, and quality assurance – microbiological or health care industry company preferred. Working experience with statistical controls and analysis, QSR, ISO 9001 preferred. Evidence of good written and oral communication skills. Proficiency with typical office software required.
Daily contact with personnel throughout company.
Activity includes walking, use of stairs, standing on concrete, sitting for long periods, and
stretching.
May be exposed to pungent odors; involves working around various chemicals, bacteria and media, and medical devices.
Skills:
1. Must understand FDA Quality System Requirements and ISO 13485/9001 as they apply to the Hopkins facility.
2. Must understand the Hopkins Complaint system and be proficient in Net Regulus to support
complaint handling.
3. Must Understand the Medical Device Reporting requirements to be able to identify potential
reportable issues.
4. Must have a firm understanding of the product documentation requirements in the device history records.
