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Quality Assurance Manager, Section Lead

2 months ago

Alameda, California, United States Abbott Laboratories Full time
About the Role

This is a pivotal position within our Quality Management Systems, ensuring excellence and regulatory compliance. As a Section Manager, QA, you will be at the forefront of driving continuous enhancement of our products and processes.

Key Responsibilities
  • Conduct thorough investigations, audits, and analyses to enhance our processes.
  • Spearhead continuous improvement initiatives tailored to our design control system.
  • Write, revise, and update Quality Assurance (QA) procedures when necessary.
  • Uphold strict adherence to Abbott Diabetes Care's Quality Management policies, as well as all relevant regulatory and corporate standards.
  • Act as the go-to Quality Assurance representative for each assigned Product Development Team.
  • Integrate quality functions into Project Teams at strategic points and ensure their presence during Phase Reviews.
  • Craft and execute a Quality Plan for each new product development endeavor, guaranteeing a seamless flow of requirements from the Design History File (DHF) to the Device Master Record (DMR) to the Device History Record (DHR).
  • Assess complaints, Corrective and Preventive Actions (CAPAs), and findings from both internal and customer audits to recommend appropriate actions.
  • Report on the progress and challenges of design control-related projects to senior management.
  • Formulate and enforce policies for Verification and Validation, including maintaining the site's Validation Master Plans.
  • Endorse validation protocols and reports after thorough review.
  • Foster and sustain productive relationships across various departments, including Research & Development (R&D), Engineering, Manufacturing, Operations, Quality Control, and Regulatory Affairs.
What You'll Work On
  • Actively engage Operations and Engineering to implement design control project deliverables.
  • Drive compliance to and Maintain DMR/DHF requirements in accordance with project time line and design control requirements.
  • Responsible for the development, approval, and change control of, quality assurance procedures and design history documentation (e.g. Design Inputs, Design Outputs, Trace Matrix, Design Verification/Validation, Change Impact Assessments, Quality Plans, Work Instructions, Protocols, Reports, FMEAs, etc.).
  • Collect and analyze quality information/data from various quality systems and develop reports.
  • Make data-driven recommendations/decisions, and take appropriate action based on the trends, communicate/report activities and status as needed for senior management review.
  • Conduct or assist in systems/process/product failure mode and effects analysis and initiation of corrective and/or preventative action as it applies design control activities.
  • Evaluate complaints, CAPAs, internal audits findings, customer audits findings and propose corrective and preventive actions.
  • Analyze, monitor and report status and issues to upper management on design control related projects.
  • Accountable for timeliness and effectiveness of Quality related deliverables for assigned projects.
  • Accountable for directing/setting Quality strategy for new product development teams.
  • Ensure project is compliant to Regulatory Compliance bodies and Abbott ADC/Corporate policies and procedures.
  • Has direct impact on the success of regulatory submissions.
Requirements
  • BS in engineering or related field.
  • 7-10 years overall experience in Quality Assurance or Engineering.
  • Minimum 5 years' experience in medical device manufacturing or pharmaceutical industries.
  • Minimum 3 years direct experience in Design Control.
  • Working knowledge applicable regulations and standards such as FDA, QSR, ISO 13485, ISO 14197, MDD, & IVDD.
  • Demonstrated written, oral, and interpersonal skills.
  • Strong analytical skills, problem-solving techniques, and statistical application experience.
  • Knowledge in the areas of Medical Device Design and Development, Design Controls, V&V activities, manufacturing practices, statistical techniques.
  • Knowledge of medical product quality assurance (including the requirements for test protocols and statistical techniques).