Veranex
Overview
Veranex is hiring for the Sr Quality Assurance Specialist role. You will be part of a team working to improve lives globally through medical technology innovation. The Sr. Quality Assurance Specialist proactively manages the various elements of the quality system to ensure compliance with applicable national and international quality system regulations. This position supports cleanroom monitoring, preventive maintenance, quality control, equipment control processes, and maintains QSR/ISO 13485 Quality Systems compliance. What You Will Do
Responsible for compiling and presenting metrics for NCRs, OOTs, PMs, etc., for monthly operations and management review meetings. Perform risk assessments for quality observations. Support process risk management for novel and existing medical devices (PFMEA). Develop, document, and validate inspection and test methods to support design control, process validation, part qualification, in-process inspection, and final inspection activities. Provide input and/or oversight for quality system-related activities, including complaint handling, CAPA investigations and supplier evaluations, as needed to assist clients in ensuring product quality and proper implementation of compliant processes. Support quality control activities such as calibration, preventive maintenance, and inspections. Drive continuous improvement efforts related to quality processes within the role. Required qualifications
Bachelors degree in engineering or life sciences, or an equivalent combination of education, training, and experience. 36 years of relevant experience. Strong investigational and communication skills, with the ability to document investigations, perform root cause analysis, and determine corrective action plans. Strong knowledge of medical device regulations and standards. Strong knowledge of medical device regulations, guidance documents and standards (QSR, ISO 13485, ISO 14971, and related guidance documents as needed). Preferred qualifications
Experience with different quality management systems. Provides risk management expertise in the evaluation and design of product. Experience in design verification and/or validation. Veranex is an equal opportunity employer and prohibits discrimination of any kind. All qualified applicants will receive consideration for employment without regard for race, color, religion or belief, sex (including pregnancy, gender identity or gender expression), sexual orientation, parental or marital status, disability, age, status as a protected veteran, national, social, or ethnic origin, or any other applicable legally protected characteristics. Job details
Seniority level: Mid-Senior level Employment type: Full-time Job function: Quality Assurance Industries: Research Services Location: Woonsocket, RI Salary: $85,987.00-$100,000.00 Posted: 18 hours ago
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Veranex is hiring for the Sr Quality Assurance Specialist role. You will be part of a team working to improve lives globally through medical technology innovation. The Sr. Quality Assurance Specialist proactively manages the various elements of the quality system to ensure compliance with applicable national and international quality system regulations. This position supports cleanroom monitoring, preventive maintenance, quality control, equipment control processes, and maintains QSR/ISO 13485 Quality Systems compliance. What You Will Do
Responsible for compiling and presenting metrics for NCRs, OOTs, PMs, etc., for monthly operations and management review meetings. Perform risk assessments for quality observations. Support process risk management for novel and existing medical devices (PFMEA). Develop, document, and validate inspection and test methods to support design control, process validation, part qualification, in-process inspection, and final inspection activities. Provide input and/or oversight for quality system-related activities, including complaint handling, CAPA investigations and supplier evaluations, as needed to assist clients in ensuring product quality and proper implementation of compliant processes. Support quality control activities such as calibration, preventive maintenance, and inspections. Drive continuous improvement efforts related to quality processes within the role. Required qualifications
Bachelors degree in engineering or life sciences, or an equivalent combination of education, training, and experience. 36 years of relevant experience. Strong investigational and communication skills, with the ability to document investigations, perform root cause analysis, and determine corrective action plans. Strong knowledge of medical device regulations and standards. Strong knowledge of medical device regulations, guidance documents and standards (QSR, ISO 13485, ISO 14971, and related guidance documents as needed). Preferred qualifications
Experience with different quality management systems. Provides risk management expertise in the evaluation and design of product. Experience in design verification and/or validation. Veranex is an equal opportunity employer and prohibits discrimination of any kind. All qualified applicants will receive consideration for employment without regard for race, color, religion or belief, sex (including pregnancy, gender identity or gender expression), sexual orientation, parental or marital status, disability, age, status as a protected veteran, national, social, or ethnic origin, or any other applicable legally protected characteristics. Job details
Seniority level: Mid-Senior level Employment type: Full-time Job function: Quality Assurance Industries: Research Services Location: Woonsocket, RI Salary: $85,987.00-$100,000.00 Posted: 18 hours ago
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