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.<\/p>\n
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Lead and oversee the validation process for manufacturing and production systems to ensure compliance with regulatory requirements and company standards.<\/p>\n
Develop and implement validation plans, protocols, and reports for new or existing products and processes.<\/p>\n
Conduct risk assessments and identify potential quality or compliance issues, providing recommendations for resolution.<\/p>\n
Collaborate with cross-functional teams to ensure timely and effective completion of validation activities.<\/p>\n
Perform data analysis and review to ensure accuracy and completeness of validation results.<\/p>\n
Identify opportunities for process improvements and provide recommendations for implementation.<\/p>\n
Communicate validation status and findings to management and other stakeholders.<\/p>\n
Develop and maintain standard operating procedures and guidelines related to validation processes.<\/p>\n
Train and mentor junior validation engineers on best practices and company standards.<\/p>\n
Stay updated on industry regulations and best practices, incorporating them into the validation process as necessary.<\/p>\n
Act as a subject matter expert on validation-related issues and provide guidance to other departments as needed.<\/p>\n
Ensure compliance with all company policies and procedures related to quality and regulatory requirements.<\/p>\n
Participate in audits and inspections, providing necessary documentation and support.<\/p>\n
Collaborate with suppliers and vendors to ensure their products and services meet quality and regulatory standards.<\/p>\n
Continuously monitor and improve the validation process to ensure efficiency and effectiveness.<\/p>\n
Where is this job?<\/p>\n
This job is located at Chaska, MN 55318, USA<\/p>\n
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Job Qualifications<\/p>\n
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.<\/p>\n
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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.<\/p>\n
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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.<\/p>\n
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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.<\/p>\n
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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.<\/p>\n
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Required Skills<\/p>\n
Risk Management<\/p>\n
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Quality Assurance<\/p>\n
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Process Improvement<\/p>\n
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Root Cause Analysis<\/p>\n
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Change Control<\/p>\n
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Compliance Management<\/p>\n
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DOCUMENT CONTROL<\/p>\n
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Audit Management<\/p>\n
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Software Validation<\/p>\n
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Validation Testing<\/p>\n
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Test Plan Development<\/p>\n
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Soft Skills<\/p>\n
Communication<\/p>\n
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Conflict Resolution<\/p>\n
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Emotional Intelligence<\/p>\n
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Leadership<\/p>\n
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Problem Solving<\/p>\n
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Time Management<\/p>\n
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Creativity<\/p>\n
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Critical Thinking<\/p>\n
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Teamwork<\/p>\n
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Adaptability<\/p>\n","protected":false},"excerpt":{"rendered":"
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 … Read more<\/a><\/p>\n","protected":false},"author":2,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[1],"tags":[],"class_list":["post-28766","post","type-post","status-publish","format-standard","hentry","category-education"],"_links":{"self":[{"href":"https:\/\/puranigaadi.com\/jobs\/wp-json\/wp\/v2\/posts\/28766","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/puranigaadi.com\/jobs\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/puranigaadi.com\/jobs\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/puranigaadi.com\/jobs\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/puranigaadi.com\/jobs\/wp-json\/wp\/v2\/comments?post=28766"}],"version-history":[{"count":1,"href":"https:\/\/puranigaadi.com\/jobs\/wp-json\/wp\/v2\/posts\/28766\/revisions"}],"predecessor-version":[{"id":28767,"href":"https:\/\/puranigaadi.com\/jobs\/wp-json\/wp\/v2\/posts\/28766\/revisions\/28767"}],"wp:attachment":[{"href":"https:\/\/puranigaadi.com\/jobs\/wp-json\/wp\/v2\/media?parent=28766"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/puranigaadi.com\/jobs\/wp-json\/wp\/v2\/categories?post=28766"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/puranigaadi.com\/jobs\/wp-json\/wp\/v2\/tags?post=28766"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}