Abbott · 23 hours ago
Quality Systems Analyst II
United States - California - Alameda
Full-time
Onsite
Mid Level
$82K/yr - $141K/yr
3+ years expAbbott is a global healthcare leader that helps people live more fully at all stages of life. The Quality Systems Analyst II will be responsible for owning complaint trend escalation investigations and ensuring that potential product and process issues are thoroughly assessed and effectively managed, applying structured root cause analysis methodologies with cross-functional partners.
BiotechnologyEmergency MedicineGeneticsHealth CareHealth DiagnosticsManufacturingMedicalMedical DeviceNutritionPharmaceutical
Responsibilities
Own complaint investigation activities related to all Abbott Diabetes Care products, ensuring compliance with procedures and timely completion
Partner with cross-functional Quality and Business Unit teams to deliver investigation results and implement impactful changes, including but not limited to
Prepare and provide relevant reports and analysis in support of internal and external audits
Support company initiatives aligned with the Quality Management System (QMS) and other regulatory requirements
Ensure compliance with FDA and international regulatory requirements, and corporate/divisional policies, procedures, and processes
Perform additional related duties and responsibilities as assigned
Qualification
Required
Bachelor's degree required
Minimum 3 years of experience in a manufacturing environment; medical device industry experience preferred
Experience conducting investigations in a regulated environment, including CAPA
Knowledge of FDA Quality System Regulations (QSR) and ISO 13485 standards
Preferred
Strong ability to manage multiple tasks and priorities in a fast-paced, changing environment
Advanced proficiency with Microsoft Office; experience with SQL is a plus
Strong analytical skills with the ability to query, refine, and summarize data in a visual format
Excellent communication skills, with the ability to interact effectively across multiple functions (Customer Support, R&D, Manufacturing) and at various levels of the organization
Proven ability to work collaboratively within a team and independently as an individual contributor
Strong organizational skills, attention to detail, and ability to meet deadlines
Demonstrated ability to leverage and engage others to accomplish projects
Benefits
Free medical coverage in our Health Investment Plan (HIP) PPO medical plan
An excellent retirement savings plan with a high employer contribution
Tuition reimbursement
The Freedom 2 Save student debt program
FreeU education benefit - an affordable and convenient path to getting a bachelor’s degree
Company
Abbott
Abbott is a healthcare company that produces diagnostic kits, medical devices, nutritional products, and branded generic medicines.
10001+ employees
Funding
Current Stage
Public CompanyTotal Funding
$6.79M2011-03-15Post Ipo Debt· $0.1M
2009-03-16Post Ipo Debt· $6.69M
1980-12-12IPO
Leadership Team
Robert Ford
President & Chief Executive Officer
Mike Peterson
Senior Vice President
Recent News
Company data provided by crunchbase