Quality Engineer II

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals, and branded generic medicines. Our 109,000 colleagues serve people in more than 160 countries.

A healthy heart is essential to good health. That’s why we’re committed to advancing treatments for people with cardiovascular disease. As a global leader in Cardiac Rhythm Technologies, our breakthrough medical technologies help restore people’s health so they can get back to living their best lives, faster. We focus on innovative technologies that can improve the way doctors treat people with heart arrhythmias, or irregular heartbeats. 

“We are seeking an experienced, high caliber Quality Engineer II for our Sylmar, CA (Device/Combination Product).

Responsible for ensuring the requirements for Device/Combination Products through the execution of Abbott standard operating procedure and Product Lifecycle Management.
 

WHAT YOU’LL DO

• Identify and implement effective process control systems to support the development, qualification, and on-going manufacturing of Device/Combination products to meet or exceed internal and external requirements

• Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues

• Lead the investigation, resolution and prevention of product and process nonconformance.

• Provide Quality support for Device-Drug Combination Product by reviewing and approving risk management activities and process control documents including batch release.

• Review and approve analytical test methods and stability activity documents to meet the standard operating procedure and compliance requirements for all products.

• Work closely and effectively with multiple functions (R&D, Operations, Regulatory Affairs and/or supply chain etc.,) to ensure production and process control expectations are met.

• Participate and represent as combination product quality assurance subject matter expert during internal, cross site and external regulatory agency inspections.

• Work with R&D in the completion of product/process verification and validation.

• Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements

• Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments. Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors

QUALIFICATIONS

• Bachelor’s degree required; typically, in Sciences, engineering or other technical scientific area.

• Minimum 2-5 years’ experience in Quality Engineering or Manufacturing Quality, Development Quality or Pharmaceutical Product Development or other related field

• Analytical Chemistry and Device regulation experience is preferred.

• Knowledge of regulations and standards affecting devices and pharmaceutical products

• Knowledge of US and EU regulations, and ISO standards.

PREFERRED QUALIFICATIONS/SKILLS:

• Previous device-drug combination product quality assurance or engineering experience

• Detailed knowledge of FDA Quality System Regulations (21 CFR Part 820), CFR Part 4, CFR Part 210/211, along with GMP, and ISO standards

• Solid communication and interpersonal skills, strong verbal and written communications with ability to effectively communicate at multiple levels in the organization.

• Ability to work in a highly matrixed and geographically diverse business environment.

• Ability to work within a team and as an individual contributor in a fast-paced, changing environment. Multitasks, prioritizes and meets deadlines in timely manner.

• Strong organizational and follow-up skills, as well as attention to detail.

• ASQ CQE, CQA certification preferred