Sr Mgr, QA Design Assurance
About the Job The Sr Manager in the Quality Assurance department is a key and critical role at FMI.
This role presents the incumbent with an opportunity to lead various teams within FMI.
As a quality people manager you will be directing quality personnel working with Product Development Teams, laboratory operations teams, or quality systems programs.
Overseeing quality deliverables in area of assignment and expertise while maintaining a competitive advantage for FMI.
This position supports the execution of the planning and work of multiple projects with a big picture mindset and is accountable for achieving all related business goals.
When working with Product Development teams on new product and design changes projects, this role supports teams and project deadlines for submission of Bioanalytical plans and reports for Premarket Approvals and supplemental PMAs or IVDR Submissions.
Additionally for Biopharma it supports clinical studies and collaborates with the partners on the clinical studies and Good Clinical Practices for the Diagnostic Device This position supports the planning and work of multiple project and scrum teams with a big picture mindset, and is accountable for achieving all related business goals.
Key Responsibilities Lead teams participating in the development and approval for design and development documents, quality system procedures, and laboratory documentation and controls.
Subject matter expert and strategist for audit-related questions within their subject matter area and beyond including front room and back room support and management for FDA, Notified Body, or pharma partners.
Ensure all activities are conducted in compliance with the FMI Quality Management System, appropriate regulations, international and national regulations and are aligned with regulatory agency expectations.
Effectively collaborate with a fully integrated team to facilitate the completion of documents.
Maintain Quality Management Systems for functional area including Design Controls, Software Development, Risk Management, Corrective and Preventative Action (CAPA) system and Non-Conforming Material Reports.
Conduct root cause analysis and implementation of correction, corrective and preventative actions and verification of effectiveness of actions as periodically required in the identification and resolution of issues.
Guide the organization on strategy and implementation of continuous improvement of the quality system.
Management of quality professionals including ensuring activities are completed in alignment with goals and continuous development of personnel.
Other duties as required.
Qualifications Basic Qualifications 2 years of management experience Bachelor's Degree in sciences or engineering discipline 6
years of experience in medical device, diagnostics, clinical laboratory or biopharmaceutical industry.
Preferred Qualifications 5
years of management experience 8
years of experience in medical device, diagnostics, clinical laboratory or biopharmaceutical industry Advanced Degree in the Sciences, Engineering or Business or a related field Experience with next generation sequencing methodology Evidence of knowledge of molecular biology Experience with IVD, or Medical Device product development, analytical validation and product approval Evidence of practical knowledge of standards and regulations pertaining to the medical device industry, both domestic and international, in particular standards set forth by the International Electrotechnical Commission and International Organization for Standardization Demonstrate ability to lead, communicate, interact and influence effectively at technical levels across functions Proficiency in Microsoft Office, Word, Excel, Project and PowerPoint Deep knowledge of bioanalytical assay development, qualification, and validation requirements that comply with current regulatory standards Proficiency in relevant analytical methodology and emerging new technologies Strong skills in troubleshooting and problem solving Comprehensive knowledge of Good Manufacturing Practices, Design Controls, Risk Management, Good Clinical Practices and Good Documentation Practices Excellent communication skills and proven ability to work effectively as a member of a multidisciplinary team Demonstrated capacity to work in a fast-paced environment with strong attention to detail Working knowledge of Next Generation Sequencing Understanding of HIPAA and importance of privacy of patient data Commitment to FMI values:
patients, innovation, collaboration, and passion #LI-Hybrid Recommended Skills Attention To Detail Auditing Biopharmaceuticals Business Process Improvement Corrective And Preventive Action (Capa) Dna Sequencing Estimated Salary: $20 to $28 per hour based on qualifications.
This role presents the incumbent with an opportunity to lead various teams within FMI.
As a quality people manager you will be directing quality personnel working with Product Development Teams, laboratory operations teams, or quality systems programs.
Overseeing quality deliverables in area of assignment and expertise while maintaining a competitive advantage for FMI.
This position supports the execution of the planning and work of multiple projects with a big picture mindset and is accountable for achieving all related business goals.
When working with Product Development teams on new product and design changes projects, this role supports teams and project deadlines for submission of Bioanalytical plans and reports for Premarket Approvals and supplemental PMAs or IVDR Submissions.
Additionally for Biopharma it supports clinical studies and collaborates with the partners on the clinical studies and Good Clinical Practices for the Diagnostic Device This position supports the planning and work of multiple project and scrum teams with a big picture mindset, and is accountable for achieving all related business goals.
Key Responsibilities Lead teams participating in the development and approval for design and development documents, quality system procedures, and laboratory documentation and controls.
Subject matter expert and strategist for audit-related questions within their subject matter area and beyond including front room and back room support and management for FDA, Notified Body, or pharma partners.
Ensure all activities are conducted in compliance with the FMI Quality Management System, appropriate regulations, international and national regulations and are aligned with regulatory agency expectations.
Effectively collaborate with a fully integrated team to facilitate the completion of documents.
Maintain Quality Management Systems for functional area including Design Controls, Software Development, Risk Management, Corrective and Preventative Action (CAPA) system and Non-Conforming Material Reports.
Conduct root cause analysis and implementation of correction, corrective and preventative actions and verification of effectiveness of actions as periodically required in the identification and resolution of issues.
Guide the organization on strategy and implementation of continuous improvement of the quality system.
Management of quality professionals including ensuring activities are completed in alignment with goals and continuous development of personnel.
Other duties as required.
Qualifications Basic Qualifications 2 years of management experience Bachelor's Degree in sciences or engineering discipline 6
years of experience in medical device, diagnostics, clinical laboratory or biopharmaceutical industry.
Preferred Qualifications 5
years of management experience 8
years of experience in medical device, diagnostics, clinical laboratory or biopharmaceutical industry Advanced Degree in the Sciences, Engineering or Business or a related field Experience with next generation sequencing methodology Evidence of knowledge of molecular biology Experience with IVD, or Medical Device product development, analytical validation and product approval Evidence of practical knowledge of standards and regulations pertaining to the medical device industry, both domestic and international, in particular standards set forth by the International Electrotechnical Commission and International Organization for Standardization Demonstrate ability to lead, communicate, interact and influence effectively at technical levels across functions Proficiency in Microsoft Office, Word, Excel, Project and PowerPoint Deep knowledge of bioanalytical assay development, qualification, and validation requirements that comply with current regulatory standards Proficiency in relevant analytical methodology and emerging new technologies Strong skills in troubleshooting and problem solving Comprehensive knowledge of Good Manufacturing Practices, Design Controls, Risk Management, Good Clinical Practices and Good Documentation Practices Excellent communication skills and proven ability to work effectively as a member of a multidisciplinary team Demonstrated capacity to work in a fast-paced environment with strong attention to detail Working knowledge of Next Generation Sequencing Understanding of HIPAA and importance of privacy of patient data Commitment to FMI values:
patients, innovation, collaboration, and passion #LI-Hybrid Recommended Skills Attention To Detail Auditing Biopharmaceuticals Business Process Improvement Corrective And Preventive Action (Capa) Dna Sequencing Estimated Salary: $20 to $28 per hour based on qualifications.
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