Welcome to Beckman Coulter – a leading global medical technology company dedicated to improving the health of people around the world. We are seeking a talented Senior QA Validation Engineer to join our team and help us ensure the quality and compliance of our life-saving products. As a Senior QA Validation Engineer, you will play a critical role in maintaining our high standards of quality and regulatory compliance by leading the validation process for our manufacturing and production systems. We are looking for a detail-oriented individual with strong problem-solving skills and a passion for delivering safe and effective products to our customers. If you are ready to make a difference in the healthcare industry and thrive in a dynamic and collaborative environment, then we want to hear from you.
Lead and oversee the validation process for manufacturing and production systems to ensure compliance with regulatory requirements and company standards.
Develop and implement validation plans, protocols, and reports for new or existing products and processes.
Conduct risk assessments and identify potential quality or compliance issues, providing recommendations for resolution.
Collaborate with cross-functional teams to ensure timely and effective completion of validation activities.
Perform data analysis and review to ensure accuracy and completeness of validation results.
Identify opportunities for process improvements and provide recommendations for implementation.
Communicate validation status and findings to management and other stakeholders.
Develop and maintain standard operating procedures and guidelines related to validation processes.
Train and mentor junior validation engineers on best practices and company standards.
Stay updated on industry regulations and best practices, incorporating them into the validation process as necessary.
Act as a subject matter expert on validation-related issues and provide guidance to other departments as needed.
Ensure compliance with all company policies and procedures related to quality and regulatory requirements.
Participate in audits and inspections, providing necessary documentation and support.
Collaborate with suppliers and vendors to ensure their products and services meet quality and regulatory standards.
Continuously monitor and improve the validation process to ensure efficiency and effectiveness.
Where is this job?
This job is located at Chaska, MN 55318, USA
Job Qualifications
Extensive Experience In Quality Assurance: A Senior Qa Validation Engineer At Beckman Coulter Must Have A Minimum Of 5-7 Years Of Hands-On Experience In Quality Assurance, Preferably In The Medical Device Or Pharmaceutical Industry.
Strong Understanding Of Regulatory Requirements: The Candidate Should Have A Thorough Understanding Of Fda Regulations, Iso Standards, And Other Relevant Regulatory Requirements To Ensure Compliance In All Validation Activities.
Expertise In Validation Methodologies: The Ideal Candidate Should Possess In-Depth Knowledge And Experience In Validation Methodologies Such As Risk-Based Validation, Process Validation, And Equipment/ Software Validation.
Excellent Communication And Analytical Skills: As A Senior Qa Validation Engineer, Effective Communication And Problem-Solving Skills Are Crucial. The Candidate Must Be Able To Communicate Clearly And Concisely With Cross-Functional Teams, Management, And Regulatory Agencies.
Leadership And Project Management Skills: The Role Of A Senior Qa Validation Engineer At Beckman Coulter Requires Leading Validation Projects And Managing The Validation Team. The Candidate Must Have A Proven Track Record Of Successful Project Management And The Ability To Lead And Motivate A Team To Achieve Project Goals.
Required Skills
Risk Management
Quality Assurance
Process Improvement
Root Cause Analysis
Change Control
Compliance Management
DOCUMENT CONTROL
Audit Management
Software Validation
Validation Testing
Test Plan Development
Soft Skills
Communication
Conflict Resolution
Emotional Intelligence
Leadership
Problem Solving
Time Management
Creativity
Critical Thinking
Teamwork
Adaptability
