Manager Product Quality Engineering, Complaints
Abbott
- Alameda, CA
- Permanent
- Full-time
- Develop Product Quality Engineering teams to isolate root causes and recommend or implement effective solutions by means of sophisticated analysis, investigative techniques and troubleshooting methods.
- Establish effective team oversight of new product development to ensure post-market surveillance capabilities at time of launch.
- Responsible for establishing ADC investigation and reporting methodology as pertaining to elevated complaints and field issues identified.
- Work with the complaints group and CAPA team to analyze product issues and then conduct investigations to root cause and identify CAs to resolve.
- Collaborate with Operations, R&D, Quality Assurance, and Customer Service to determine cross-functional evaluation, investigation, and solutions.
- Represent Complaint Handling and Product Quality Engineering in escalations and urgent issues being addressed at a crossfunctional or divisional level.
- Reviews and provides functional approval for project and quality system documentation
- Develops and implements
Minimum 4 years Overall quality experience in a FDA/ISO regulated environment.
Substantial demonstrated initiative and problem-solving skills; critical-thinking skills, preferably in a CAPA environment
Experience in leading & managing people.
Experience working in an investigative role in a Quality management system, in collaborations with Quality Assurance/ with
Operations and R&D.
- 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.
Alameda : 1360-1380 South Loop RoadADDITIONAL LOCATIONS:WORK SHIFT: StandardTRAVEL: Yes, 20 % of the TimeMEDICAL SURVEILLANCE: NoSIGNIFICANT WORK ACTIVITIES: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day), Keyboard use (greater or equal to 50% of the workday)Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans.EEO is the Law link - English: http://webstorage.abbott.com/common/External/EEO_English.pdfEEO is the Law link - Espanol: http://webstorage.abbott.com/common/External/EEO_Spanish.pdf