Quality Systems Analyst II

About the position

This position works out of our Westford, MA location in the Abbott Vascular Division. Abbott Vascular provides innovative, minimally invasive, and cost-effective products for the treatment of vascular disease. This is an onsite daily required position. No relocation assistance is available for this position. Open to consider candidates at a lower level.

Responsibilities

• Establish and maintain effective structures to ensure consistent implementation of quality systems at Abbott.
• Create processes and process improvements to ensure consistent implementation of internal requirements and external laws, regulations, guidances, and standards (LRGS).
• 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 ensure 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.
• Cultivates 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.
• Provides guidance to less experienced staff.
• Influence exerted at peer level and occasionally at first levels of management.
• Plans, organizes, and prioritizes own daily work routine to meet established schedule.

Requirements

• Bachelor's Degree (Sciences/Engineering) or an equivalent combination of education and work experience.
• Minimum 2 years of related work experience with a good understanding of specified functional area.
• Working knowledge and application of business concepts, procedures and practices.
• Experience in a quality system environment.

Nice-to-haves

• General knowledge of technical alternatives and an understanding of their impact on the systems environment.

Benefits

• Career development with an international company.
• Free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year.
• Excellent retirement savings plan with a high employer contribution.
• Tuition reimbursement and the Freedom 2 Save student debt program.
• FreeU education benefit - an affordable and convenient path to getting a bachelor’s degree.
• Paid time off.
• 401(k) retirement savings with a generous company match.
• Health care and well-being programs including medical, dental, vision, wellness and occupational health programs.