QA Specialists

Profile

This position is an integral part of our client's quality Department. It requires organization and attention to detail while working with other Quality functions to ensure compliance and the accomplishment of departmental and company goals.





JOB / DUTIES / RESPONSIBILITIES

• Generate, review and maintain Quality records in support of the Quality System, e.g., training, internal audits, NCR, and CAPA.

• Perform basic product testing and failure analysis.

• Review and track Lot Acceptance records and DHRs, create trend charts

• Data logging Quality data and trending results. Gather data where needed. This involves reminding, chasing, and expediting.

• Assist in gathering information during FDA and ISO 13485 inspections.

• Other duties as assigned.

JOB QUALIFICATIONS

Knowledge / Education

• AS or BS degree in engineering, a technical or scientific discipline; or equivalent experience.

Job Experience

• 3 years in a regulated industry (Medical Device Industry preferred).

• Minimum of 2 years in a Quality related function working with QSR and/or ISO 13485.

Skills / Competencies

• Effective verbal and excellent technical writing skills.

• Ability to communicate and work effectively within the organization.

• Ability to organize and follow through with tasks sometimes with minimal supervision.

• Excels at generating and maintaining organized and accurate records.

• MS Office, strong word processing and spreadsheet skills.
Posted by lou pipitone

Company info

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