Quality Inspector

Sanderson Recruitment Ireland

Offaly

A unique role for a well established medical device company. In this role as the QA Inspector you will be responsible for: Day to day inspection criteria for inspection and release of medical device products and associated components. documentation of release activities in line with local Quality Management Systems QMS procedure requirements. Support process improvements and validation activities. Working within the QA team to support improvement activities. Qualifications: You will have ideally the following: Engineer/Science qualification with minimum of 2 years working within QA in a multi-national medical devices manufacturing environment. Knowledge of ISO 13485 and 21CFR820 (FDA 21 CFR Part 820), also known as the QSR outlines current CGMP regulations that govern the methods used in, and the facilities and controls used for, the design, manufacture, packaging, labeling, storage, installation, and servicing of all finished devices. Also knowledge of MDSAP the Medical Device Single Audit Program (MDSAP) is a program that allows the conduct of a single regulatory audit of a medical device manufacturer's quality management system that satisfies the requirements of multiple regulatory jurisdictions. along with exposure to other regulations. Experience in dealing with Operations to support plant attainment. Support to the Engineering department on the execution of validation protocols. Attention to detail and accuracy - essential. Ability to work well under deadlines and pressure. Strong skills for developing creative solutions and meeting objectives are required. Experience in internal auditing to FDA Quality System Regulation (QSR) standards and ISO 13485 requirements an advantage. Please apply to have a confidential discussion with Nicola. This job originally appeared on RecruitIreland.com.

1767 days ago