Quality App Spec

Medtronic•Juncos, PR

1d•Onsite

About The Position

A Quality Application Specialist supports the implementation, maintenance, and improvement of quality-related software systems used to ensure products and processes meet regulatory and organizational standards. The role typically involves configuring and supporting quality management systems (QMS), troubleshooting application issues, managing system updates, and ensuring data integrity within quality platforms. They collaborate with cross‑functional teams such as quality assurance, regulatory, IT, and manufacturing to ensure systems align with compliance requirements (for example FDA or ISO standards) and business needs. The specialist may also assist with user training, documentation, audits, and continuous improvement initiatives to help maintain efficient and compliant quality operations.

Requirements

Requires practical knowledge and demonstrated competence within job area typically obtained through advanced education combined with experience.
Requires a Baccalaureate degree (or for degrees earned outside of the United States, a degree which satisfies the requirements of 8 C.F.R. § 214.2(h)( 4)(iii)(A) and minimum of 2 years of relevant experience, or advanced degree with 0 years of experience.
For Baccalaureate degrees earned outside of the United States, a degree that satisfies the requirements of 8 C.F.R. § 214.2(h)(4)(iii)(A) is required.
The employee is regularly required to be independently mobile.
The employee is also required to interact with a computer, and communicate with peers and co-workers.
Roles below the Principal level require candidates to possess unrestricted U.S. work authorization at the time of hire and for the duration of employment.

Nice To Haves

Validation Knowledge
Chemical Laboratory Knowledge
Labware knowledge

Responsibilities

Conducts a compliant validation process for quality information technology systems which requires formal validation documentation (including standard operating procedures) under appropriate federal regulations.
Coordinates activities with clients, programmers/developers and operating personnel, domestic and, as appropriate, global.
Identifies current and anticipated requirements for compliant computerized operations and suggests methods for the identification, implementation and maintenance of the procedures, actions and documentation necessary to assure compliance according to the appropriate federal and international regulations which govern the user's applications.
Reports on the status of validation activities to fulfill regulatory requirements.
Keeps abreast of changing federal and international regulatory requirements, government audit policies, and the availability of current techniques.
Performs system administration and configuration of quality information technology systems.