Associate Quality Specialist

1020 Abbott Diabetes Care Inc; Alameda (CA); On-site; USD 74,000 - 116,000; Full time

Benefits offered by this job

Free medical HIP PPO

Strong retirement plan

Tuition reimbursement

FreeU education benefit

Job summary

Abbott in Alameda, CA is seeking an Associate Quality Specialist to support Quality Assurance and the Quality System onsite Monday through Friday. This role emphasizes implementing and maintaining the Quality System and participating in CAPA activities, training, audits, and documentation in a fast-paced healthcare environment.

Qualifications include a bachelor’s degree and knowledge of FDA QSRs, ISO 13485, and quality management practices.

Qualifications

• Bachelor’s degree required.
• 0-2 years of experience in internship, co-op or equivalent.
• Knowledge of FDA Quality System Requirements and regulatory standards.
• Knowledge of ISO 13485 standard.
• Knowledge of quality management techniques and application.
• Ability to clearly and accurately convey communications.
• Ability to work independently and in groups.

Responsibilities

• Implement and maintain the effectiveness of the Quality System.
• Participate in Quality System processes (CAPA, audits, validation).
• Assist in determining quality attributes and requirements.
• Provide technical assistance when needed.
• Conduct investigations and drive corrective actions.
• Complete documentation promptly according to standards.
• Collaborate on cross-functional teams.
• Meet established objectives and drive cross-functional performance.
• May train personnel as directed by management.

Skills

Quality management

Analytical thinking

Communication skills

Cross-functional collaboration

Problem solving

Organizational skills

Multitasking

Education

Bachelor’s degree

Job description

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 122,000 colleagues serve people in more than 160 countries.

Associate Quality Specialist

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.

Responsibilities

• 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.
• Knowledge of FDA Quality System Requirements and other applicable U.S. 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.

Preferred Qualifications

• Medical device industry experience preferred.
• Knowledge of FDA Quality System Requirements and other applicable U.S. 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.

The base pay for this position is $73,900.00 – $116,000.00 In specific locations, the pay range may vary from the range posted.

JOB FAMILY: Operations Quality
DIVISION: ADC Diabetes Care
LOCATION: United States > Alameda : 2901 Harbor Bay Parkway
ADDITIONAL LOCATIONS: WORK SHIFT: Standard
TRAVEL: No
MEDICAL SURVEILLANCE: No
SIGNIFICANT WORK ACTIVITIES: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day), Keyboard use (greater or equal to 50% of the workday)

Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans. EEO is the Law link - English: http://webstorage.abbott.com/common/External/EEO_English.pdf EEO is the Law link - Espanol: http://webstorage.abbott.com/common/External/EEO_Spanish.pdf

Abbott is about the power of health. For more than 135 years, Abbott has been helping people reach their potential — because better health allows people and communities to achieve more. With a diverse, global network serving customers in more than 160 countries, we create new solutions — across the spectrum of health, around the world, for all stages of life. Whether it’s next-generation diagnostics, life-changing devices, science-based nutrition, or novel reformulations, we are advancing some of the most innovative and revolutionary technologies in healthcare, helping people live their best lives through better health.

Follow Us: Facebook LinkedIn YouTube Twitter