Associate Quality Specialist

Abbott • Alameda, CA

8d • $73,900 - $116,000 • Onsite

About The Position

The Associate Quality Specialist supports the efficient functioning of Quality Assurance and the Quality System through administrative and tactical activities. Based at Abbott Diabetes Care in Alameda, California, the role is expected to be onsite Monday through Friday. The specialist works under the supervision of more experienced staff, who review work for accuracy, completeness, and sound judgment. The position is responsible for meeting established objectives and goals, supporting cross-functional performance, and complying with applicable EHS policies, procedures, and guidelines.

Requirements

• Bachelor’s degree required.
• 0–2 years of experience in a combination of internship, co-op, or equivalent experience.
• Ability to clearly, concisely, and accurately convey communications.
• Ability to form and develop interpersonal, professional relationships and display socially and professionally appropriate behavior.
• Ability to work independently, in groups, and cross-functionally.
• Demonstrated 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 quickly gain knowledge, understanding, or skills, 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, potentially including training, CAPA activities, equipment maintenance, product and process planning, quality audits, and validation.
• Assist in determining quality attributes and requirements and may provide technical assistance.
• Use quality management techniques to conduct investigations and facilitate solutions.
• Complete documentation in a timely manner and in accordance with business standards.
• Participate on cross-functional teams.
• Complete other tasks and duties as assigned.
• Understand and comply with applicable EHS policies, procedures, and guidelines.
• Recognize risks relative to potential gains, understand project critical success factors, and make recommendations and decisions that affect those factors.
• Meet established objectives and goals and drive functional performance to meet cross-functional standards and expectations.
• May assist with training personnel as directed by management.

Benefits

• Employees may qualify for free medical coverage in 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.
• Career development opportunities with an international company.

What This Job Offers

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