Make a Meaningful Difference to Patients Around the World
We are seeking a Quality Inspector at our manufacturing facilities, where our dedicated teams create innovative tools and technologies that transform patients' lives. Your attention to detail and commitment to continuous improvement will help us turn ideas into reality.
Job Summary
The Quality Inspector is responsible for assessing devices in-process and upon completion, reviewing accompanying documentation, and conducting audits to ensure compliance with regulatory and company guidelines. This role requires a high level of independence and productivity.
Key Responsibilities:
* Perform visual, dimensional, and functional inspection on various components and/or finished medical device products using a range of tools and equipment to ensure conformance with design specifications.
* Utilize a microscope for inspections, in keeping with associated SOPs, and operate automated inspection equipment to verify dimensional requirements.
* Conduct operational audits and documentation reviews to ensure compliance with applicable procedures and documentation standards.
* Review and follow established work instructions and adhere to SOPs, including recording traceable information on device history records and utilizing computer programs to perform specific job tasks.
* Provide core team feedback, escalating work issues and changes in devices and raw materials to higher levels (e.g., Engineering Support) for assessment and correction.
* Ensure smooth shift transitions by providing status debriefs of shift activities.
* Participate in special projects, performing Test Method Validations (TMVs), protocols, first article inspections, etc.
Requirements:
* 2 years of previous related experience, including GMP and GDP.
* Leaving Certificate or equivalent.
* Good communication skills.
* Able to read, comprehend, speak, and write English.
* Basic computer skills, required, including working knowledge of manufacturing software.
* Straight attention to detail.
* Ability to use applicable tools and equipment, hand-eye coordination, and high manual dexterity.
* Full understanding of applicable inspection procedures.
Preferred Skills:
* Ability to clearly describe and convey nonconformance issues, and enter them into QMS (Quality Management System).
* Must be able to work in a team environment and with minimum supervision by following detailed work instructions.
* Ability to effectively provide and accept feedback from colleagues.