Title: QA Specialist II
Location: Alameda, CA
Duration: 12 Months
Responsibilities
- Assures the postmarket quality of manufactured products and processes per standard operating processes(SOP'S) and GMP (Good Manufacturing Practices).
- Own CAPA from initiation through effectiveness verification for issues arising from complaint/PMS trends, audit/inspection observations, and process gaps, drive timely closure and sustainable outcomes.
- Author/redline complaint handling procedures (SOPs/WIs/forms/trainings), manage change control, develop/deliver training, and monitor adoption and effectiveness.
- Lead continuous improvement of the PMS complaint handling process (e.g., streamline workflows and templates, enhance coding taxonomies, improve data quality and cycle time, reduce backlog).
- Trend and analyze complaint/PMS data to detect signals; summarize findings and recommend/implement controls (e.g., quality holds, stop shipments) in partnership with Global Customer Service, Quality, Regulatory, Manufacturing/FA, Track and Trend, R&D and various other groups.
- Prepare for and support audits/inspections (FDA, Notified Body, MDSAP, Corporate) as SME for complaint handling/PMS; ensure documentation is complete, accurate, and readily retrievable.
- Collaborate cross?functionally (Customer/Technical Support, Complaint Investigations Group, Medical Events Team, R&D, CAPA, Quality Compliance, Regulatory, Clinical, etc) to elevate Complaint evaluation and investigation quality, close knowledge gaps, and drive corrective actions.
- Support new product introduction (as needed) by providing complaint/PMS feedback to risk management and ensuring complaint codes, workflows, and training are in place.
- Support complaint evaluation and closure activities, including complaint quality reviews and supplier quality reviews.
- Experience: 3-7 years, working with complaint/ med device
- OUS/ Redline procedures/ Report ability/ experience/ CAPA
- Evaluation and closure/ reportability/ report the complaint file oversee the procedures
- Working knowledge of 21 CFR 803/820/806, ISO 13485, ISO 14971, MDSAP, EU MDR; strong complaint GDP/GMP documentation discipline
- Experience with a complaint management system (e.g., Salesforce, TrackWise or similar) and cross?functional complaint investigation workflows.
- Demonstrated ability to prioritize independently, make sound regulatory decisions, and communicate clearly and professionally across functions.
- Proficiency in Microsoft Office (Excel, PowerPoint, Word, Outlook). Preferred Experience: Direct experience in medical device complaint handling and/or post?market surveillance in a regulated environment
- Proven process ownership for Complaint Handling (SOP/WI authoring/redlining, change control, training).
- CAPA leadership (problem statement/scoping, root cause analysis, action planning, effectiveness checks).
- Familiarity with data trending and root?cause methodologies (DMAIC, 5 Whys, Fishbone) and basic statistics/SPC experience with MAUDE searches a plus.
- A detail-oriented individual with a 'can do' attitude and the ability to work in a team environment as well as individually (with minimal supervision).
- Ability to work in a fast-paced environment with multiple tasks/projects.
- Experience supporting audits/inspections as an SME.
- Education: Associate Degree with complaint experience 3-7 years / Master degree may apply
Consultants Eligible Benefits Upon Waiting Period
- Medical and Prescription Drug Plans
- Dental Plan
- Vision Plan
- Health Savings Account (for High Deductible Health Plans)
- Flexible Spending Accounts (Health, Limited Purpose, Dependent Care, Commuter Parking and Commuter Transit)
- Supplemental Life Insurance
- Short Term Disability (coverage varies by state)
- Long Term Disability
- Critical Illness, Hospital coverage, Accident Insurance
- MetLife Legal, MetLife ID Fraud, and MetLife Pet Insurance
- 401(k)
Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritional and branded generic medicines.
Working together, Abbott and Talent Solutions partner to deliver top talent for contingent roles at Abbott, building better and healthier lives. Abbott believes all employees are essential to creating life-changing breakthroughs, performing key duties to create life-changing breakthroughs.
