Associate Quality Engineer

Abbott•Arecibo, PR

15h•Onsite

About The Position

This exempt position is based at Abbott’s Arecibo, Puerto Rico location in the Cardiac Rhythm Management division and supports first-shift manufacturing operations. The role provides primary engineering support for an assigned manufacturing line, working closely with the line supervisor, Quality Engineer, and operators. The engineer is accountable for the line’s quality, safety, output, and yield, and may also provide sustaining engineering support for the department. The role supports manufacturing and process improvements, defect reduction, equipment availability, change management, investigations, validations, and product builds through the NPI process. It also contributes to compliance and EHS activities and may initiate, investigate, or approve CAPA records.

Requirements

Bachelor of Science degree in an engineering discipline; Mechanical, Electrical, or Industrial Engineering is preferred.
Basic knowledge of applicable U.S. and non-U.S. regulations.
Knowledge and proficiency in the principles and application of Manufacturing or Process Engineering.
Ability to communicate effectively across functions to help resolve quality and engineering issues.
Excellent written, verbal, and interpersonal communication skills in both English and Spanish.
Knowledge of common office applications, including Word, PowerPoint, and Excel.
Ability to interact effectively with employees at all levels.

Nice To Haves

Basic statistics knowledge.

Responsibilities

Be accountable for output, safety, yield, and quality for the assigned manufacturing line.
Identify product defects and determine operational or process actions to reduce them, including equipment troubleshooting and work-order requests as needed.
Work with the line support team to triage line situations, assess whether a non-conformance exists, establish initial bracketing and containment, and support generation of an ER when needed.
Maintain product and process knowledge, including understanding the basic cause and effect of line and process changes.
Develop and implement engineering fixes for the line, including tooling and manufacturing aids.
Support maintenance technicians and supervisors with equipment availability issues; review completed equipment work orders and perform product impact analysis before releasing equipment for commercial manufacturing use.
Support the Training and Certification Program.
Determine the quality impact of Out-of-Tolerance documents.
Execute line-related change management for material, equipment, and process changes, and generate simple COs and CRs related to changes affecting the line.
Develop and execute simple continuous improvement projects and exception subtasks; evaluate LPI program ideas for potential implementation.
Lead root-cause analysis for basic or simple manufacturing events using DMAIC and A3s; support major CAPA investigations with data gathering and analysis as needed.
Run line studies and validations as needed, and write protocols and reports with oversight.
Represent line support on projects involving yield improvement, continuous improvement, productivity, quality, and safety.
Coordinate product builds through the NPI process and generate simple changes to the eLHR system.
Apply a basic understanding of applicable compliance and EHS regulations in the work area; recommend and execute improvements as needed.
May initiate, investigate, and/or approve CAPA records, and support EHS and regulatory compliance audits.