Search jobs > Alameda, CA > Quality assurance specialist

Senior Specialist Quality Assurance

Abbott
Alameda, CA, United States
Full-time

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 114,000 colleagues serve people in more than 160 countries.Working at AbbottAt Abbott, you can do work that matters, grow, and learn, care for yourself and 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.

Free medical coverage for employees* via the Health Investment Plan (HIP) PPOAn excellent retirement savings plan with high employer contributionTuition 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 around the world 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 a best place to work for diversity, working mothers, female executives, and scientists.

The OpportunityThis position works out of our Alameda, CA location in the Diabetes Care division where 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.As the Quality Systems Analyst II you will be responsible for various data analysis activities including : complaints trending, MDR / MDV trending, and providing data reporting inputs for Management Review and various reporting and month end activities.

What You’ll Work OnInternal liaison and expert for Complaint Handling database development, maintenance, and sustainment activities.

Partner with cross-functional Quality and Business Unit Teams to fulfill reporting requirements. Includes, but not limited to : Complaints Trending and summaries;

FDA Medical Device Reporting trending and summaries; EU Medical Device Vigilance reporting trending and summaries; and Weekly, monthly and quarterly product line complaints reporting.

Support internal and external audits by preparing and providing relevant reports and analysis.Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.

Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments.

Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.

Performs other related duties and responsibilities, on occasion, as assigned.Required QualificationsBachelors Degree or an equivalent combination of education and work experienceMinimum 5 years in a manufacturing environmentPreferred QualificationsMedical Device experience preferredAbility to manage multiple tasks and priorities.

Strong Microsoft Office capabilitiesExperience with automated database systems.Knowledge and experience with InfoMed and SAP Enterprise Software highly desirable.

Ability to query and refine data into summarized results.Experience with Microsoft SQL Server, Reporting Services, Analysis Services, a plus.

Experience working in a broader enterprise / cross-division business unit model preferred.Ability to work in a highly matrixed and geographically diverse business environment.

Ability to work within a team and as an individual contributor in a fast-paced, changing environment.Ability to leverage and / or engage others to accomplish projects.

Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization.Multitasks, prioritizes and meets deadlines in timely manner.

Strong organizational and follow-up skills, as well as attention to detail.Ability to travel including internationally.Apply Now ()Participants who complete a short wellness assessment qualify for FREE coverage in our HIP PPO medical plan.

Free coverage applies in the next calendar year.Learn 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.

Abbott is an Equal Opportunity Employer, committed to employee diversity.Connect with us at www.abbott.com , on Facebook at www.

facebook.com / Abbott and on Twitter @AbbottNews and @AbbottGlobal.The base pay for this position is $83,600.00 $167,200.

00. In specific locations, the pay range may vary from the range posted.An Equal Opportunity EmployerAbbot welcomes and encourages diversity in our workforce.

We provide reasonable accommodation to qualified individuals with disabilities.To request accommodation, please call 224-667-4913 or email corpjat@abbott.com

3 days ago
Related jobs
Promoted
Cytovale, Inc
San Francisco, California

As a Quality Assurance Specialist, you will be responsible for supporting the product development life-cycle within the Cytovale QMS, and assist in the support of various quality system processes including Document Control, Receiving/Incoming. Successful candidates will work well in a fast-paced sta...

Promoted
Bell Bros
Mather, CA, US

As a Quality Assurance Specialist at Bell Brothers, you will play a crucial role in identifying and qualifying potential customers, driving lead generation, and contributing to the sales pipeline. Achieve productivity standards and goals set by the company while maintaining high-quality calls. ...

Promoted
Annexon, Inc.
South San Francisco, California

Quality Assurance (QA) Director/Senior Director. Provide Clinical Quality Assurance (GCP) strategic and technical leadership and Subject Matter Expertise (SME) to clinical study teams; Partner with the teams to effect appropriate and timely documentation of quality event management, including CAPA p...

Promoted
Maze Therapeutics
South San Francisco, California

Are you ready to make a real difference in patients’ lives and thrive in a fast-paced team-oriented environment? We’re on a mission to revolutionize healthcare through the power of human genetics, and we need a talented and highly motivated Senior Manager of Quality Assurance (QA) to join our team. ...

Promoted
TELUS International
Oakland, California

Proficient in conducting research and fact-checking to ensure quality. The review process will include but not limited to provide feedback on observed opportunities, edit audited products to ensure accuracy and quality expectations are achieved. ...

Penumbra
Alameda, California

The Quality Assurance Engineering Specialist I will support quality engineering activities to ensure the compliance of these systems with domestic and international regulations. Assist in various other Quality Specialist tasks as needed. Adhere to the Company’s Quality Management System (QMS) as wel...

R&D Partners
California, CA

Quality Assurance Specialist II. Quality Assurance Specialist II:. Quality Assurance Specialist II:. Perform a wide variety of quality assurance activities to ensure compliance with procedures, applicable US and international regulatory requirements for biologic drug substances and drug products und...

Yoh, A Day & Zimmermann Company
South San Francisco, California

Senior Manager, GMP Quality Assurance. Minimum of 2 years’ experience in a GMP Quality Assurance role. Oversee all required quality activities during the lifecycle of a GxP supplier (Source & Select, Implement, Manage, and Decommission), such as due diligence and/or audit assessments, risk assessmen...

SS&C Technologies Holdings
San Francisco, California

Senior Quality Assurance Engineer. We are seeking a detail-oriented Senior QA Engineer who is involved in the entire product development life cycle and is motivated to deliver high-quality software products. Advocate and champion quality mindset across your team(s) and the solution(s)  – build-...

CoStar Group
CA, Orange County

An understanding of quality assurance test methodologies, deliverables, processes, strategies, metrics, techniques and the software development life cycle (SDLC), is critical. Ensures that products conform to business requirements/company policies, software quality standards, and established procedu...