Quality Assurance Associate

Quality Assurance Associate

Job Description

Directly responsible for performing certain Quality Management System (QMS) activities and supporting the performance of other QMS activities as part of the RA/QA Department. The position reports to the VP RA/QA.

Perform the following QA activities

Manage the incoming inspection process and the company document control system

Coordinate the following processes: approved supplier’s, lot release, change control (ECO), nonconforming product (NCR), complaint handling, verification and validation (V&V) testing activities including preparation of protocols and reports and test execution

Maintain Design History File (DHF), Device Master Record (DMR) and QMS SOPs

Support the following QA activities: risk management, corrective and preventive action (CAPA), internal and external audits

Support the following Operations activities:

Purchasing, shipments, warehouse and office management

Experience/Skills Required

Practical engineering degree or equivalent technical certification, or

Bachelor’s degree in engineering or scientific discipline - an advantage

At least 3-5 years work experience in a medical device QA role working under an ISO 13485 certified QMS

Excellent communication, organizational and recordkeeping skills

Strong English technical writing skills, most of the work is in English

Must be fluent with MS Office in particular Excell

Must be able to work in a fast-paced environment with demonstrated ability to juggle multiple competing tasks and demands

Must be able to work in multi-disciplinary teams

Must be a team player

Experience with clean room manufacturing - an advantage

• Experience with V&V testing - an advantage