Quality Engineer I

About Abbott

Abbott is a worldwide leader in healthcare, dedicated to improving life at every stage. Our extensive array of life-transforming technologies encompasses diagnostics, medical devices, nutrition, and generic branded pharmaceuticals. With 115,000 colleagues across more than 160 countries, we serve people globally.

Role Overview

We are focused on advancing solutions for cardiovascular disease treatment. As a pioneer in Cardiac Rhythm Technologies, our cutting-edge medical devices aid patients in recovering health swiftly from arrhythmias, irregular heartbeats affecting heart function. We seek a Quality Engineer I to join our Operations Quality Engineering team in Sylmar, CA. This role is responsible for developing quality engineering approaches and providing support during new product design, production, and service operations.

Key Responsibilities

• Develop and deploy effective process control systems supporting product development, qualification, and ongoing manufacturing to ensure internal and external requirements are met or exceeded.
• Lead implementation of assurances, process controls, and CAPA (Corrective and Preventive Actions) systems aimed at compliance with standards.
• Contribute to streamlined business systems that proactively identify and resolve quality-related issues.
• Utilize systematic problem-solving tools to prioritize, communicate, and address quality defects.
• Design and run experiments aimed at optimizing and improving manufacturing processes.
• Document experimental plans, conduct protocol writing, and report generation.
• Manage control and monitoring of critical-to-quality (CTQ) parameters and product specifications.
• Lead product and process improvement initiatives applying methods such as Six Sigma and Lean Manufacturing.
• Oversee investigation, resolution, and prevention of product or process non-conformances.
• Participate in or lead cross-functional teams representing quality disciplines and decisions.
• Lead risk analysis maintenance.
• Collaborate with design engineering on product verification and validation activities.
• Coordinate with microbiology teams to ensure environmental monitoring meets requisite standards.
• Support company-wide initiatives in line with Quality Management Systems (QMS), Environmental Management Systems (EMS), and regulatory compliance.
• Ensure compliance with FDA regulations, company policies, and other relevant procedures.
• Maintain positive and cooperative communication with employees, customers, contractors, and vendors.
• Perform other assigned relevant duties as needed.

Qualifications and Experience

• Bachelor's degree in Engineering or a related technical field, or equivalent experience. Master's degree with approximately 18 years of experience preferred.
• This is an entry-level role typically suited to candidates with 0-2 years of experience.
• Minimum of 2 years engineering experience involving quality tools and methodologies, with solid understanding of FDA, GMP, ISO 13485, and ISO 14971 standards.
• Strong interpersonal and communication skills, with project management and leadership experience, including leading multi-departmental teams and resolving quality issues efficiently.
• Advanced computer proficiency including statistical and data analysis, and report preparation capabilities.
• Experience in the medical device industry and application of product/process improvement techniques like Six Sigma and Lean Manufacturing is preferred.
• Certifications such as ASQ Certified Quality Engineer (CQE) are advantageous.
• Experience in cross-divisional enterprise business environments preferred.
• Ability to work both independently and collaboratively in a fast-evolving setting, managing multiple priorities and deadlines with attention to detail.

Benefits and Perks

• Comprehensive onboarding and continual career development training, including tuition assistance.
• Competitive salary with incentive programs and retirement plans ensuring financial security.
• Complete healthcare and wellness packages covering medical, dental, vision, and occupational health.
• Generous paid time off.
• 401(k) retirement savings plan with company matching contributions.
• Stability and growth opportunity within a financially strong organization committed to community involvement.

Additional Information

The position location is Sylmar, CA (Los Angeles area). The base salary range is from $73,900 to $116,000 annually, which may vary depending on location. Abbott is an Equal Opportunity Employer dedicated to workforce diversity.