Senior Manufacturing Operations Specialist
hace 1 semana
Company Overview
At Abbott, we're dedicated to advancing the treatment of heart disease through breakthrough medical technologies.
About the Role
This position is based out of our Costa Rica – Alajuela location in the EP Division. We're seeking a skilled Senior Manufacturing Operations Specialist to join our team.
Daily Responsibilities
As a Senior Manufacturing Operations Specialist, you will:
- Support manufacturing activities to meet established goals for safety, quality, cost, and production.
- Maintain systems that support the monitoring of key performance indicators such as yield, nonconforming material, or lead-time.
- If indicators show an adverse trend, work with the functional team to plan and implement appropriate changes.
- Understand product cost components and its interactions, including direct & indirect material costs, MUV, labor, overhead.
- Use product cost knowledge to identify risks and opportunities.
- Keep equipment operational by coordinating calibration, maintenance, and repair services.
- Perform installation/validation activities for new or existing production lines, meeting regulatory requirements.
- Estimate validation activities cost and ensure it is budgeted within financial cycle.
- Identify, select, and purchase equipment/fixtures according to production requirements.
- Participate in the identification and investigation of Non-conforming products.
- Use Root cause problem solving techniques to identify and eliminate causes, implement controls, and define preventive activities.
- Evaluate the financial, process, or quality impact derived from product & process changes.
- Use statistical techniques to facilitate decision making and draw conclusions from available data.
- Lead or support local cross-functional team activities.
- Support/lead global initiatives with other functions and sites (e.g., RA, R&D, QA).
- Lead or support CAPA investigation processes or exception documents such as complaints investigations.
- Lead or support continuous improvement projects for any of the main key areas: safety, quality, and production.
Required Skills and Qualifications
To be successful in this role, you will need:
- Bachelor's Degree in STEM careers.
- 4+ years of working experience in similar roles.
- Statistical techniques knowledge (DOE, SPC) is required.
- PE license is a plus.
- Computer software knowledge (Microsoft Word, Excel, PowerPoint).
- Knowledge of FDA, GMP, and ISO guidelines.
- Familiar with Lean manufacturing concepts and continuous improvement methodologies.
- Experience leading validation plans for medical industry products and processes and leading root cause problem-solving methodologies.
- Experience in project management.
- Willingness to travel.
- Fully bilingual English-Spanish (required).
Estimated Salary Range
$80,000 - $110,000 per year, depending on experience and qualifications.
About the Location
The position is based in Costa Rica – Alajuela location in the EP Division.
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