Associate Quality Specialist

Abbott • Alameda, CA

7d • Onsite

About The Position

The Associate Quality Specialist supports the efficient functioning of Quality Assurance and the Quality System through administrative and tactical activities. This position is based at Abbott Diabetes Care in Alameda, California, and is onsite Monday through Friday. The role works under the supervision of more experienced staff, who review work for accuracy, completeness, and sound judgment. The specialist is responsible for meeting established objectives and goals and helping ensure cross-functional standards and expectations are met.

Requirements

• Bachelor’s degree.
• 0–2 years of experience through a combination of internship, co-op, or equivalent experience.
• Ability to communicate clearly, concisely, and accurately.
• Ability to develop interpersonal and professional relationships and display socially and professionally appropriate behavior.
• Ability to work independently, in groups, and cross-functionally.
• Initiative and problem-solving skills.
• Critical-thinking skills.
• Ability or aptitude to use databases and other computer software.
• Strong organizational skills and ability to prioritize and multitask.
• Ability or aptitude to develop solutions and contingency plans through comprehensive review of alternatives.
• Ability to learn quickly and willingness to learn.

Nice To Haves

• Medical device industry experience.
• Knowledge of FDA Quality System Requirements and other applicable US Code of Federal Regulations for Devices.
• Knowledge of the ISO 13485 standard.
• Knowledge of quality management techniques and their application.

Responsibilities

• Implement and maintain the effectiveness of the Quality System.
• Participate in Quality System processes, which may include training, CAPA activities, equipment maintenance, product and process planning, quality audits, and validation.
• Assist in determining quality attributes and requirements, and provide technical assistance as needed.
• Use quality management techniques to conduct investigations and facilitate solutions.
• Complete documentation promptly and in accordance with business standards.
• Participate on cross-functional teams.
• Understand and comply with applicable EHS policies, procedures, and guidelines.
• Recognize risks relative to potential gains, understand project critical success factors, and make recommendations or decisions that affect those factors.
• Meet established objectives and goals and support cross-functional performance standards and expectations.
• Assist with personnel training as directed by management.
• Perform other assigned tasks and duties.

Benefits

• Career development opportunities with an international company.
• Employees may qualify for free medical coverage through the Health Investment Plan (HIP) PPO medical plan in the next calendar year.
• Retirement savings plan with a high employer contribution.
• Tuition reimbursement.
• Freedom 2 Save student debt program.
• FreeU education benefit, an affordable and convenient path to earning a bachelor’s degree.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level