Sr. QA Specialist North LA

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 113,000 colleagues serve people in more than 160 countries.

Job Description

About Abbott

Abbott is a global healthcare leader, creating breakthrough science to improve people’s health. We’re always looking towards the future, anticipating changes in medical science and technology.

Working at Abbott

At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. You will have access to:

• Career development with an international company where you can grow the career you dream of.

• Health Insurance (starting on Day 1 of employment), Savings Plan (401K) with company match, Life insurance for you and your spouse/children, Short Term Disability, Long Term Disability, Education Assistance, Employee Assistance Program, Vacation, Sick, Personal Days.

• A company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune.

• A company that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientists

The Opportunity

This position works out of our location in San Juan, Puerto Rico location in the Abbott Vascular Commercial Division. Our medical devices help more than 10,000 people have healthier hearts, improve quality of life for thousands of people living with chronic pain and movement disorders, and liberate more than 500,000 people with diabetes from routine fingersticks and Abbott Vascular provides innovative, minimally invasive, and cost-effective products for treatment of vascular disease.

As the Sr. QA Specialist North LA, you’ll provide supports quality compliance by following the process and procedures established in the Quality System for Vascular Commercial Affiliate.

What You’ll Do

• Supports QA Manager to ensures North LA Quality System effectiveness and compliance.

• Being responsible for quality system processes as SME: Supplier Controls and Evaluation, Distributor Management, Market Feedback and Product Experience Reporting, Field and Post-Market Communications, Documentation and Record Control, External Standards and Regulation Compliance, Ad Promo Document Control; or its backup e.g.: CAPA, Storage and Handling of Finished Vascular Medical Devices, Management Review, Change Control, Customer and Product Training.

• Being responsible for maintaining update Puerto Rico´s learning plan for Abbott Vascular personnel, including SH-Mitraclip for Caribbean Region.

• Participates in Quality System improvements and implementation projects - Participate in the continuous improvement of core processes to ensure quality is maintained while efficiency is optimized .

• Review Abbott Policies, Procedures and External Regulations and update Quality System accordingly - Supports / prepares/ coordinates external audits.

• Participate in internal and supplier audits - Coordinate any audit input to affected processes following change control procedures.

• Report and conduct follow up for customer complaints and product issues as per established procedures in the affiliate.

• Review cGMP regulation applicable to North LA for ensuring company processes compliance.

• Train and aid less experienced members of the QA team and Affiliate on quality procedures.

• Recommend, implement, and monitor preventative and corrective actions to ensure that the quality system is in compliance.

Required Qualifications

• Bachelor’s degree in Pharmaceutical Chemistry or Chemical Engineer.

• Minimum two years of related work experience or equivalent combination of education and work experience.

• Certificate/Graduate Degree as preference.

• Proficiency in intermediate/advanced English.

• Acknowledgement in Quality Assurance role within Medical Devices Industry.

• Experience with FDA and worldwide Medical Device Regulation (ISO 13485, ISO 9001).

• Strong attention to detailed and be self-motivated.