Product Surv Quality Assoc III
Round Lake, IL
Req ID 49871BR
Business Title
Product Surv Quality Assoc III
Business
Global Quality
Sub-Business
Global Field Surveillance
Country
US
State/Province
Illinois
Location of Position
Round Lake, IL
Shift_
1st
Job Description
This position is responsible for managing in-depth complaint investigations, with expert product knowledge. This role is responsible for report submissions to regulatory bodies and providing information to Baxter business units for decision-making purposes. This position is a subject matter expert in the team and will train and mentor other Product Surveillance Quality Associates.
•Process high-risk (Death/Serious Injury) complaints (without supervision):
•Collect necessary complaint information
•Determine reportability of a complaint and submit associated Medwatch reports within 30 days per regulations
•Lead the investigation, including developing investigation plan, defining members of investigation team and their roles and responsibilities, plan on-site visits, follow-up communication with internal and external customers
•Travel to customer sites to obtain information pertinent to the investigation, including sample, clinical and engineering information
•Document investigation and sample evaluation results
•Respond to customer complaints (written or verbal)
•Timely closure of complaints, as per procedure
Guide Specialists leading high-risk investigations, review MDRs associated with death and serious injury.
•Perform trend reporting and escalate results to appropriate business units for consideration of necessary actions.
•Manage internal process improvements and projects. Identify continuous improvement opportunities for the department and champion their implementation. Represent Product Surveillance on Product Improvement Teams, as well as CAPA.
•Participate in mentoring and training for the Product Surveillance Team.
•Manage workflow; identify and escalate issues.
•Ability to perform all duties required of previous levels.
Job Requirements
•Expert knowledge of the FDA Quality System and Medical Device Reporting regulations (21 CFR 803, 806, 820 and 211.) Understanding of regulations governing markets outside the U.S.
•Expert understanding of the product's intended use and manufacturing process of assigned products. Readily accepting of assignments to new/ different products and required participation on product launches.
•Ability to prioritize multiple high risk projects to ensure compliance with regulations and standard operating procedures.
•Excellent written/verbal communication and organizational skills
•Ability to make independent decisions
•Excellent problem solving and analytical skills Education and Experience:
•Bachelor's degree and /or clinical certification (MT, RN) required
•Minimum of 1 year as a Associate II or 7 years relevant experience, which should include Product Surveillance, direct clinical/medical experience, or relevant Product/Technical expertise Preferred Qualifications:
•Medical / surgical and / or renal clinical experience
•Previous experience managing CAPA and FDA Quality System and Medical Device Reporting Regulations
Doing Work that Matters
Baxter provides its employees with comprehensive compensation and benefits. To view additional opportunities at Baxter and to learn more about the company, please visit our Web site at company website. EOE M/F/D/V.
