The Opportunity
This position works out of our Arecibo location in the CRM division.
As a global leader in Cardiac Rhythm Technologies, we focus on innovative technologies that can improve the way doctors treat people with heart arrhythmias, or irregular heartbeats.
Shift : First shift- Monday to Friday
As the Associate Quality Assurance, you will support Quality Engineers and Quality Management in implementing and maintaining the effectiveness of the Quality System by maintaining metric dashboards, tracking line support and process monitoring key indicators, identifying and dispositioning manufacturing process defects (scrap, nonconforming material, etc.), assisting in the identification of primary root causes and understanding corrective / preventive actions.
What You’ll Do
- Responsible for compliance with applicable Corporate and Divisional Policies and procedures.
- Learns Process Monitoring Systems by becoming familiar with systems applications and critical process steps; and uses this knowledge to reduce process variation.
- Learns Quality Tools & Training Materials by gaining knowledge of prevalent tools used and by reviewing & utilizing available training materials.
- Assist Product / Process improvement efforts by systematically gathering quality metric data (e.g. : yield, scrap, rework, nonconforming product, among others) and by assisting in the continuous improvement of existing and new product / processes.
- Works with line support team (QC Supervisor, Ops. Supervisor, Manufacturing Engineer, Mfg. Eng. Technician, and Quality Engineer) to perform line situation triage and determine if non-conformance is present, execute initial bracketing and containment, and initiate exception management process.
- May own basic NCMR / CAPA activities with Quality Management or Quality Engineer oversight.
- May provide technical assistance with testing or engineering studies and documenting findings / results.
- Responsible for completing documentation in a timely manner and in accordance with business standards.
- Implements minor changes through change management system and may support major change implementation.
- Runs routine problem-solving investigation with direction and use of basic engineering principles.
- Participates on cross-functional teams.
- Other tasks and duties, as assigned.
Required Qualifications
Bachelor's degree in STEM field.0 - 2 years of related work experience with a basic understanding of specified functional area.Bilingual. Fluent in English and Spanish.Technical / Business Knowledge : Basic technical knowledge of concepts, practices and procedures. Limited understanding of business unit / group function. Will perform this job in a quality system environment. Failure to adequately perform tasks can result in noncompliance with governmental regulations.Cognitive Skills : Learns to use professional concepts and company policies and procedures to solve routine problems. Works on problems of limited scope. Minimal independent decision making. Works under general supervision.Preferred Qualifications
Previous experience in medical devices or pharmaceutical industry is preferred.Preferred experience in Quality (technical or professional role), Medical Device Mfg. Line Support, CA / PA investigations and problem solving, metric management and experience managing systems / databases / indicators.