Please Send resumes to o...@alliedinformatics.com or call me on my number 678-710-8104
Hi, This is Omer from *Allied Informatics .* We do have a position for *Quality Validation Lead* Please find the job description below and if interested please send me your updated word format resume. *Allied Informatics *is a professional service organization helping customers create synergies of information through the use of leading edge software applications. To know more about *Allied Informatics *please visit us at www.alliedinformatics.com *Job Title : **Quality Validation Lead* *Location : Minneapolis, MN* *Duration : 12+ Months* *Job Summary* The Senior Quality/Validation Engineer provides regulatory guidance, quality direction and oversight/coordination for validation initiatives and deliverables. The position is responsible to assure compliance to regulations, respond to issues/challenges and limit exposure to liability and risk. A seasoned and expert resource works with multiple levels of staff to assure validation initiatives are accurate, complete and compliant to internal Client Quality processes and external regulations. In addition to leading validation initiatives, this function provides consultative services regarding internal Quality processes and external regulations. Responsibilities · Lead, manage and plan system validation efforts; make decisions regarding validation approach, structure, and deliverables compliant with internal Client Quality processes; participate in development of validation work estimates · Develop and implement solutions to validation (process) challenges and issues, assuring compliance · Guide/coach system/team members in writing validation documen0ts/deliverables; ability to write validation documents/deliverables · Create/execute and/or direct validation activities, traceable to system requirements, Part 11 requirements (when applicable) and design elements · Apply sound, systematic problem solving methodologies in identifying, prioritizing, communicating and resolving issues · Guide testing activities as needed, including but not limited to, test case writing, test execution, defect management · Ability to write and execute test cases as needed · Perform quality review, edit and approval of validation documents/deliverables, pre/post test case executions · Collaborate with system owner or delegates in the development of business and functional requirements and other verification/validation processes; ability to write requirements · Partner with system and technical resources to perform risk analysis and identify how to mitigate · Participate in requirements analysis for new systems and architecture to determine Validation needs · Provide validation leadership and consulting expertise in the planning and implementing of validation efforts to assure compliance against Client Quality System processes and system validation programs · Maintains knowledge of current validation industry trends as related to both domestic and international regulations · Provides leadership, guidance, and training to less-experienced staff members Requirements · Demonstrated expertise and concept application of FDA part 820, ISO 13485 regulations (and FDA General Principles of Software Validation Guidance), 21 CFR Part 11, industry best practices · Minimal travel required (less than 10%) · Bachelor’s degree in Information Systems, Health Management, Software Quality or related field; or equivalent work experience · 7+ years in a medical device regulated industry, or related industry · 3+ years working knowledge of IT systems, networks, operating systems, and processes · 3+ years in a manufacturing environment (desirable) · Experience in leading complex validation initiatives and multi-tasking with diverse groups and locations · Demonstrated ability to adhere to internal Quality processes and external regulations · Experience conducting requirement/design risk assessments in regulated industry · Strong analytical skills and attention to detail · Ability to work efficiently and independently with minimal supervision (i.e. self-motivated and willing to stretch to meet important deadlines) · Ability to work successfully in a cross-functional team environment · Project Management experience a plus · Excellent written skills are a must · Demonstrated problem solving skills · Demonstrated organizational skills, attention to detail, the ability to handle multiple assignments simultaneously in a timely manner, and be able to meet assigned deadlines and service levels · Demonstrated interpersonal skills, including the ability to listen, resolve problems, deal with unresolved issues, delays and unexpected events, and the ability to effectively communicate and maintain rapport with supported customers and management · Working knowledge of regulatory quality systems Technical Domain Qualifications · Solid understanding of Installation Qualification for IT hardware/software Thanks, Omer Hussain Allied Informatics, Inc. 1815 Satellite Blvd. Suite 302 Duluth, GA 30097 USA Phone: 770-246-9800 ext : 109 I D: 678-710-8104 I Fax: 770-246-9098 Email: o...@alliedinformatics.com I URL: www.alliedinformatics.com NOTE: If this email message has reached you in error and if you do not wish to receive similar messages in future, please reply with "REMOVE" in the subject line. 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