JOB DESCRIPTION:Sr. Specialist Quality Assurance The OpportunityThe 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
Apply NowLearn more about our health and wellness benefits, which provide the security to help you and your family live full lives: www.abbottbenefits.com
Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life.
Divisional InformationMedical 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
ADDITIONAL LOCATIONS: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)
