Associate Specialist Quality

Associate Specialist Quality

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 114,000 colleagues serve people in more than 160 countries.

The Associate Specialist Quality 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.
• Medical device industry experience preferred.

Preferred Qualifications:

• 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.

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