Quality Systems Associate — QA & Compliance

Abbott; 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 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.