Quality Section Leader at Abbott

Alajuela, Alajuela, Costa Rica

Apply Now

Not SpecifiedCompensation

Senior (5 to 8 years), Expert & Leadership (9+ years)Experience Level

Full TimeJob Type

UnknownVisa

Healthcare, Medical DevicesIndustries

Requirements

Bachelor’s Degree in Engineering, Science or Technical Field, or Bachelor's degree in Business Administration
5 to 7 years of experience with preferably 4+ years in quality engineering roles
Solid knowledge of and experience working with international quality regulations, including US 21 CFR 820 (QSR) and ISO 13485
Demonstrated and impactful experience with product and process qualification and validation, process improvement, lean and six sigma methodologies, process control and monitoring (SPC)
Demonstrated results in nonconformance management and reduction, value improvement, risk reduction, and cost containment
Demonstrated organizational influence to include compliance excellence, organizational improvement, product-related risk mitigation, and/or manufacturing cost reduction
Bilingual English/Spanish (required)
SHIFT C: Monday - Friday 10:00 pm - 06:00am. Works 100% On site

Responsibilities

Management and development of Quality Engineers and Technicians
Provide Quality Engineering Body of Knowledge guidance and leadership to department and organization
Identify opportunities to proactively assure compliance to all applicable internal, domestic and international quality regulations, US 21 CFR 820 (QSR), ISO 13485, etc
Identify and manage activities related to adding value to the organization through risk reduction, cost improvement, and budgetary responsibility
Define and implement Process Control & Monitoring systems
Provide influential peer leadership with international partner site to drive proactive quality improvements
Identify Quality Initiatives and lead cross-functional teams to complete them
Provide proactive, diligent, and fact-based communication to Sr. Management team, peers and team
Developing, establishing and maintaining quality assurance programs, policies, processes, procedures and controls ensuring that performance and quality of products conform to established standards and agency regulations

Skills

ISO 13485

21 CFR 820

QSR

Quality Assurance

Quality Engineering

Regulatory Compliance

Risk Management

Process Improvement

Team Leadership

Budget Management

Abbott

Healthcare solutions in diagnostics and devices

About Abbott

Abbott Laboratories focuses on improving health through various medical technologies and health solutions. The company operates in areas such as cardiovascular health, diabetes management, diagnostic testing, nutrition, and neuromodulation for chronic pain and movement disorders. Abbott's products include advanced medical devices and diagnostic tests that help healthcare professionals and patients manage health conditions effectively. For example, their cardiovascular technologies assist in heart health management, while diabetes care products enable accurate glucose monitoring without painful fingersticks. Unlike many competitors, Abbott emphasizes accessibility and affordability in its offerings, aiming to make life-changing technologies available to a broader audience. The company's goal is to positively impact global health and well-being, supported by a commitment to sustainability and a 2030 Sustainability Plan.

Lake Bluff, IllinoisHeadquarters

1888Year Founded

IPOCompany Stage

HealthcareIndustries

10,001+Employees