Senior Specialist Quality Assurance

Abbott • Alameda, CA

1d • Onsite

About The Position

The Sr. Specialist Quality Assurance will conduct quality-related activities to deliver consistent, high-quality documents, services, products, and processes. This is a 5 days/week onsite opportunity based out of Alameda, CA.

Requirements

• Bachelor’s degree in Life Sciences, Engineering, or a related discipline.
• Minimum of 5 years of experience in Quality or a related field.
• An equivalent combination of education and relevant work experience will also be considered.
• Demonstrates good, general understanding of the standards and regulatory bodies that regulate our industry.

Nice To Haves

• Candidates with an advanced degree (Master’s or Ph.D.) may qualify with less experience.
• Preferred experience in the Healthcare industry.
• Has a history of completing successful projects and driving positive compliance outcomes

Responsibilities

• Defines project goals and milestones.
• Responsible for timely project completion.
• Provides solutions to a wide range of difficult problems.
• Ensures that solutions are compliant, innovative, thorough, practical and consistent with organizational objectives.
• May lead projects with cross-functional or broader scope.
• Interacts effectively with employees, manager, and cross-functional peers.
• May represent own team while on cross-functional project teams with other functional leaders.
• Provides guidance and trains other Professionals and Technicians.
• May provide oversight to one or more QA professionals and/or contractors.
• Communicates confidently and effectively with management, peers, and key stakeholders.
• Implements tactical solutions related to assignment.
• Able to contribute functional skills and expertise broadly.
• Directly influences project direction and scope.
• Scope includes one or more QA functions, with general knowledge of other related disciplines.
• Ensures compliance to site level policies and procedures and demonstrates a solid understanding of Division and Corporate policies and procedures by promptly addressing noncompliance issues within Division and Corporation as appropriate.
• Ensures adherence and maintains the effectiveness of the Quality System, including the Subsystems and Key processes that govern the area by promptly addressing non-compliance issues.
• Leads quality system activities including CAPA, nonconformance investigations, root cause analysis, effectiveness verification, and implementation of sustainable corrective actions.
• Identifies trends and continuous improvement opportunities to ensure ongoing compliance and process effectiveness.
• Analyzes quality system data, including complaints, nonconformances, CAPAs, audits, supplier performance, and post-market surveillance information to identify trends and assess effectiveness of quality processes.
• Monitors and interprets evolving regulatory requirements, standards, and industry expectations; performs impact assessments and partners with cross-functional teams to implement compliant solutions and maintain inspection readiness.
• Serves as a Quality Systems SME by providing training, mentoring, and guidance on quality processes, regulatory requirements, investigations, CAPA activities, and continuous improvement initiatives.

Benefits

• 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.

What This Job Offers

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