Associate Quality Specialist

Abbott; United States; On-site; USD 65,000 - 85,000; Full time

Benefits offered by this job

Health benefits including HIP PPO plan

Retirement plan with employer match

Tuition reimbursement and FreeU

Global company with growth and career

Job summary

Abbott in Alameda, CA is seeking an Associate Quality Specialist. This onsite role focuses on supporting Quality Assurance activities and maintaining the Quality System. You'll work Monday–Friday on site, collaborating with cross-functional teams to ensure compliance and product quality.

Ideal candidates have a bachelor's degree and 0–2 years of internship or related experience, with a willingness to learn and grow within a global leading healthcare company.

Qualifications

• Bachelor's degree required.
• 0-2 years of internship/co-op or equivalent experience.

Responsibilities

• Implement and maintain the Quality System.
• Participate in CAPA, audits, validation activities.
• Assist in determining quality attributes and requirements.
• Complete documentation in a timely manner according to standards.
• Contribute to cross-functional teams and training as needed.

Skills

Quality Assurance

CAPA processes

Data analysis

Education

Bachelor's degree

Job description

Associate Quality Specialist

Working at Abbott

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

• Career development with an international company where you can grow the career you dream of.
• Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year.
• An excellent retirement savings plan with a high employer contribution.
• Tuition reimbursement, the Freedom 2 Save student debt program, and FreeU education benefit - an affordable and convenient path to getting a bachelor's degree.
• A company recognized as a great place to work in dozens of countries worldwide 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 the best place to work for diversity, working mothers, female executives, and scientists.

The Opportunity

The Associate Quality Specialist is responsible for administrative and tactical activities that support the efficient functioning of Quality Assurance and the Quality System. This position will be based out of our Abbott Diabetes Care in Alameda, CA and the individual will be expected to be onsite Monday-Friday.

What You'll Work On

• Responsible for implementing and maintaining the effectiveness of the Quality System.
• Participate in Quality System processes which may include training, corrective action and preventive action (CAPA) activities, equipment maintenance, product and process planning, quality audits, validation.
• Assist in determining quality attributes and requirements. may provide technical assistance.
• Utilize quality management techniques to perform investigations and facilitate solutions.
• Responsible for completing documentation in a timely manner and in accordance with business standards.
• Participate on cross-functional teams.
• Other tasks and duties as assigned.
• Understand and comply with applicable EHS policies, procedures and guidelines.
• Works under the supervision of more experienced staff who review results for overall accuracy, completeness and sound judgment.
• Recognizes risks versus the relative gains associated with actions; understands a project's critical success factors and makes recommendations and decisions impacting those factors.
• Responsible to meet established objectives and goals.
• Drives functional performance to ensure that cross-functional standards and expectations are met.
• May assist in the training of personnel as directed by management.

Required Qualifications

• Bachelor's degree required.
• 0-2 years of experience in a combination of internship, co‑op or equivalent experience.

Preferred Qualifications

• Medical device industry experience preferred.
• Knowledge of FDA Quality System Requirements and other applicable US Code of Federal Regulations for Devices.
• Knowledge of ISO 13485 standard.
• Knowledge of quality management techniques and application.
• Ability to clearly, concisely and accurately convey communications.
• Ability to form and develop interpersonal, professional relationships.
• Display socially and professionally appropriate behavior.
• Ability to work independently and in groups.
• Ability to work cross‑functionally.
• Demonstrated initiative and problem‑solving skills.
• Critical‑thinking skills.
• Ability or aptitude to use various types of databases and other computer software.
• Strong organizational skills.
• Ability to prioritize.
• Ability to multitask.Ability or aptitude to provide solutions and contingency plans through the comprehensive review of alternatives.
• Ability to quickly gain knowledge, understanding or skills and is willing to learn.