Job TitleQuality Systems Analyst II
The OpportunityWe are seeking a
Quality Systems Analyst II to work our
Westford, MA location for our Abbott Vascular division. This is a fully onsite role.
Abbott Vascular provides innovative, minimally invasive and cost-effective products for treatment of vascular disease. Our extensive portfolio includes drug-eluting stents, bare metal stents, guide wires, balloon dilatation catheters, imaging catheters and software, vessel closure devices and peripheral stents.
What You'll Work OnThis position is responsible for various data analysis activities including: nonconformance trending, quality metric trending, and providing data reporting inputs for Management Review and various reporting and month end activities.
- Internal liaison and expert for quality metric database development, maintenance, and sustainment activities.
- Partner with cross-functional Quality and Business Unit Teams to fulfill reporting requirements. Includes, but not limited to: nonconformance/Corrective Action and Preventative Action (CAPA) 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 Qualifications- Bachelors Degree in a related field OR an equivalent combination of education and work experience
- Minimum 3 years in a manufacturing environment. Medical Device experience preferred.
- Ability to manage multiple tasks and priorities.
- Strong Microsoft Office capabilities required.
- Experience 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 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.
The base pay for this position is $61,300.00 - $122,700.00
In specific locations, the pay range may vary from the range posted.
JOB FAMILY:Quality Assurance
DIVISION:AVD Vascular
LOCATION:United States > Massachusetts > Westford : 4 Robbins Road
ADDITIONAL LOCATIONS:WORK SHIFT:Standard
TRAVEL:Yes, 5 % of the Time
MEDICAL SURVEILLANCE:No
SIGNIFICANT WORK ACTIVITIES:Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day), Continuous standing for prolonged periods (more than 2 consecutive hours in an 8 hour day)
