The Opportunity
This Quality Systems Analyst, Intermediate. works out of our Temecula CA location in the Abbott Vascular Division. 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 On
- Identify internal requirements and external laws, regulations, guidances and standards (LRGS) applicable to one or more of Abbott's quality systems.
- Interpret applicable internal requirements and external LRGS and incorporate into requirements for use in Abbott business processes.
- Identify areas of potential noncompliance within Abbott.
- Review and update the Quality System Manual as needed.
- Educate functional areas on quality system requirements.
- Participate cross functionally and across business units to standardize Abbott business quality system policies and procedures.
- Mediate resolution of interdepartmental and cross business unit process conflicts.
- Identify qualified external consultants and experts in government, collaborating with them to insure correct interpretation of LRGS.
- Collect business process data from different parts of the company for analysis.
- Act as an expert resource in specific LRGS requirement knowledge for Abbott.
- May be responsible for identifying training requirements, programs, and tracking systems.
- Cultivate a wide range of internal networks and begins to develop an external network of resources to facilitate completion of tasks.
- May demonstrate basic project management skills by acting as a project lead on small, well defined projects.
- Provide guidance to less experienced staff.
Required Qualifications
Bachelor's degree plus 2+ years of related work experience with a basic understanding of specified functional area, or an equivalent combination of education and work experience.Working knowledge and application of business concepts, procedures and practices.Will perform this job in a quality system environment.