Senior Specialist Quality Assurance

Regulatory Toolkit; Alameda (CA); Presencial; USD 100.000 - 200.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Free medical coverage in HIP PPO

Retirement plan

Tuition reimbursement

Free U education benefit

Descripción de la vacante

Abbott is seeking a Sr. Specialist Quality Assurance to perform quality-related activities and deliver high-quality documents, services, products, and processes. This onsite role is based in Alameda, CA.

The position involves leading QA initiatives, CAPA investigations, regulatory compliance, and continuous improvement within Quality Systems. A strong cross-functional collaboration mindset is required for success.

Formación

• Bachelor’s degree in Life Sciences, Engineering, or related discipline.
• Minimum of 5 years of experience in Quality or related field.
• Equivalent combination of education and relevant work experience will be considered.

Responsabilidades

• Defines project goals and milestones; ensures timely completion.
• Provides solutions that are compliant, innovative, thorough, practical and aligned with objectives.
• May lead cross-functional projects and guide/ train QA professionals or contractors.
• Communicates effectively with management and stakeholders.
• Implements tactical solutions and contributes across QA functions; operates within related disciplines.

Conocimientos

Quality Assurance

Regulatory knowledge

Cross-functional collaboration

Educación

Bachelor’s degree in Life Sciences or Engineering

Descripción del empleo

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.

JOB DESCRIPTION:

Sr. Specialist Quality Assurance

Working at Abbott

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 forfree medical coverage in ourHealth Investment Plan (HIP) PPOmedical 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 Sr. Specialist Quality Assurance will onduct 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.

What You’ll Work On

• 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.

Quality System Compliance

• Demonstrates good, general understanding of the standards and regulatory bodies that regulate our industry. 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.

Required Qualifications

• Bachelor’s degree in Life Sciences, Engineering, or a related discipline.
• Minimum of 5 years of experience in Quality or a related field. Candidates with an advanced degree (Master’s or Ph.D.) may qualify with less experience.
• An equivalent combination of education and relevant work experience will also be considered.

Preferred Qualifications

• Preferred experience in the Healthcare industry.
• Has a history of completing successful projects and driving positive compliance outcomes

Divisional Information

Medical Devices

General Medical Devices:

Our medical devices help more than 10,000 people have healthier hearts, improve quality of life for thousands of people living with chronic pain and movement disorders, and liberate more than 500,000 people with diabetes from routine fingersticks.

Diabetes

We’re focused on helping people with diabetes manage their health with life-changing products that provide accurate data to drive better-informed decisions. We’re revolutionizing the way people monitor their glucose levels with our new sensing technology.

The base pay for this position is

$100,000.00 – $200,000.00

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

WORK SHIFT

Standard

TRAVEL

Not specified

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