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Overview
The Manager of Quality Engineering is responsible for ensuring that VIVEX Biologics' Quality Engineering, Risk Management, and Validation programs comply with all applicable regulatory and industry standards, including but not limited to FDA regulations and AATB standards. This position oversees the CAPA system, including managing CAPAs, non-conformities, planned deviations, errors, and deviations, and supports the Supplier Quality program. The Manager will lead a team of Quality Engineering personnel, perform key document approvals, procedure development, and reporting to senior management. The Manager of Quality Engineering drives quality initiatives, maintains compliance, and fosters collaboration across departments to ensure high standards of product and process excellence. Qualifications and responsibilities at a glance include:
14 duties spanning personnel management, validation support, regulatory compliance, CAPA/risk management, supplier quality, regulatory inspections, quality metrics, and leadership. Duties and responsibilities
Directly and indirectly responsible for personnel management of VIVEX-wide Quality engineering function including compliance, planning for staffing levels, identifying necessary skill sets, recruiting, personnel development, personnel resource allocation, performance evaluations, performance feedback, bonus/merit recommendations, and training/competency files. Also performs active management and observations of personnel for process efficiencies. Support the design analysis, and approval of all VIVEX process validation and equipment qualifications. This encompasses laboratory instruments equipment, process equipment and the introduction of new processes and any activity associated with contract packaging or filling. This includes but is not limited to reporting results to management and reviewing data with internal stakeholders, internal or external auditors, and/or regulatory agencies. Develop and implement the strategic direction for validations aligned with all VIVEX projects. Lead, drive and participate in interdepartmental teams to develop specification, procedural and regulatory compliance of tissue forms, medical devices and, when applicable, biologics. Compose and update quality engineering standard operating procedures, specifications, and validation procedures. Responsible for CAPA and risk management programs encompassing errors, deviations, SCARs, NCRs, complaints and adverse events. This includes the review of the investigation, the risk management, the root cause, and the acceptance or rejection of the product. Support deviation reporting including NCRs, CAPA, audit findings, improvement and trends requiring action. This includes investigations, root cause analysis, reporting, provision of evidence, and verification of effectiveness of actions. Actively works with leadership on deviation and issues involving the controlled environment, processing areas, and associated equipment. Responsible for performing technical investigations, risk assessments, validation impact assessments, root cause analysis, and corrective and preventive actions related to non-conformances, deviations, and customer complaints. Assist the supplier quality program to review VIVIEX suppliers and provide quality functional input into the performance and monitoring of suppliers. Support the regulatory inspections and audits at VIVEX sites Will be accountable for quality metrics to identify systemic product and process issues assuring appropriate investigation, correction, and corrective and preventive action when needed Responsible for communicating business related issues or opportunities to senior management Responsible for ensuring that subordinates follow all Company guidelines related to Health, Safety and Environmental practices and that all resources needed to do so are available and in good condition, if applicable Other duties as assigned. Requirements
Education: · Bachelor’s degree in engineering, Life Sciences, or a related technical field (e.g., Mechanical, Biomedical, Chemical, or Industrial Engineering) required. · Master’s degree in engineering, Quality Management, Regulatory Affairs, or Business Administration (MBA). · Certifications such as CQE (Certified Quality Engineer), CQA (Certified Quality Auditor), or Lean Six Sigma Green/Black Belt. Professional Experience: · 5–7 years of progressive experience in quality engineering, quality assurance, or manufacturing engineering in a regulated industry (medical device, biotech, pharmaceutical, or tissue banking) required. · At least 2 years of supervisory or team lead experience, demonstrating ability to manage people, projects, and cross-functional initiatives required. · Hands-on experience with ISO 13485, 21 CFR Part 820 (QSR), and risk management (ISO 14971) requirements required. · 8–10+ years of experience in medical devices, with increasing leadership responsibilities. · Prior experience in design control, process validation, test method validation, and statistical techniques (e.g., DOE, SPC, GR&R). · Experience leading or supporting regulatory inspections and third-party audits (FDA, ISO, MDSAP, Notified Body). · Familiarity with supplier quality management, product development lifecycle, and post-market quality engineering (complaints, CAPA, reliability engineering). Core Competencies & Skills · Strong knowledge of root cause analysis, CAPA management, and risk analysis tools (FMEA, Fault Tree, etc.). · Ability to mentor and develop engineers, ensuring alignment with compliance and continuous improvement objectives. · Excellent communication skills, able to work with both technical staff and executive leadership. · Proficiency in quality system software, data analysis tools, and project management. Working conditions
Must be willing to work weekends and evening hours as necessary. Must be willing to accommodate travel if necessary. The job may require work to be performed inside the controlled cleanroom manufacturing area where the engineer would be exposed to tissue processing. Physical requirements
While performing the duties of this job, the employee is regularly required to sit for prolonged periods of time. The employee may occasionally be required to pull, lift and/or move objects weighing up to 30 pounds. Direct reports
Quality Engineers Quality Assurance Coordinators Nothing in this job description restricts management’s right to assign or reassign duties and responsibilities to this job any time. Vivex is an equal opportunity employer (EEO) and expressly prohibits any form of workplace discrimination and/or harassment based on , , , , , or expression, , , genetic information, , or veteran status. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, transfers, leaves of absence, compensation and training. Vivex complies with the Americans with Act (ADA) which prohibits discrimination against qualified individuals with disabilities who, with or without reasonable accommodation, can perform the essential functions of a job.
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The Manager of Quality Engineering is responsible for ensuring that VIVEX Biologics' Quality Engineering, Risk Management, and Validation programs comply with all applicable regulatory and industry standards, including but not limited to FDA regulations and AATB standards. This position oversees the CAPA system, including managing CAPAs, non-conformities, planned deviations, errors, and deviations, and supports the Supplier Quality program. The Manager will lead a team of Quality Engineering personnel, perform key document approvals, procedure development, and reporting to senior management. The Manager of Quality Engineering drives quality initiatives, maintains compliance, and fosters collaboration across departments to ensure high standards of product and process excellence. Qualifications and responsibilities at a glance include:
14 duties spanning personnel management, validation support, regulatory compliance, CAPA/risk management, supplier quality, regulatory inspections, quality metrics, and leadership. Duties and responsibilities
Directly and indirectly responsible for personnel management of VIVEX-wide Quality engineering function including compliance, planning for staffing levels, identifying necessary skill sets, recruiting, personnel development, personnel resource allocation, performance evaluations, performance feedback, bonus/merit recommendations, and training/competency files. Also performs active management and observations of personnel for process efficiencies. Support the design analysis, and approval of all VIVEX process validation and equipment qualifications. This encompasses laboratory instruments equipment, process equipment and the introduction of new processes and any activity associated with contract packaging or filling. This includes but is not limited to reporting results to management and reviewing data with internal stakeholders, internal or external auditors, and/or regulatory agencies. Develop and implement the strategic direction for validations aligned with all VIVEX projects. Lead, drive and participate in interdepartmental teams to develop specification, procedural and regulatory compliance of tissue forms, medical devices and, when applicable, biologics. Compose and update quality engineering standard operating procedures, specifications, and validation procedures. Responsible for CAPA and risk management programs encompassing errors, deviations, SCARs, NCRs, complaints and adverse events. This includes the review of the investigation, the risk management, the root cause, and the acceptance or rejection of the product. Support deviation reporting including NCRs, CAPA, audit findings, improvement and trends requiring action. This includes investigations, root cause analysis, reporting, provision of evidence, and verification of effectiveness of actions. Actively works with leadership on deviation and issues involving the controlled environment, processing areas, and associated equipment. Responsible for performing technical investigations, risk assessments, validation impact assessments, root cause analysis, and corrective and preventive actions related to non-conformances, deviations, and customer complaints. Assist the supplier quality program to review VIVIEX suppliers and provide quality functional input into the performance and monitoring of suppliers. Support the regulatory inspections and audits at VIVEX sites Will be accountable for quality metrics to identify systemic product and process issues assuring appropriate investigation, correction, and corrective and preventive action when needed Responsible for communicating business related issues or opportunities to senior management Responsible for ensuring that subordinates follow all Company guidelines related to Health, Safety and Environmental practices and that all resources needed to do so are available and in good condition, if applicable Other duties as assigned. Requirements
Education: · Bachelor’s degree in engineering, Life Sciences, or a related technical field (e.g., Mechanical, Biomedical, Chemical, or Industrial Engineering) required. · Master’s degree in engineering, Quality Management, Regulatory Affairs, or Business Administration (MBA). · Certifications such as CQE (Certified Quality Engineer), CQA (Certified Quality Auditor), or Lean Six Sigma Green/Black Belt. Professional Experience: · 5–7 years of progressive experience in quality engineering, quality assurance, or manufacturing engineering in a regulated industry (medical device, biotech, pharmaceutical, or tissue banking) required. · At least 2 years of supervisory or team lead experience, demonstrating ability to manage people, projects, and cross-functional initiatives required. · Hands-on experience with ISO 13485, 21 CFR Part 820 (QSR), and risk management (ISO 14971) requirements required. · 8–10+ years of experience in medical devices, with increasing leadership responsibilities. · Prior experience in design control, process validation, test method validation, and statistical techniques (e.g., DOE, SPC, GR&R). · Experience leading or supporting regulatory inspections and third-party audits (FDA, ISO, MDSAP, Notified Body). · Familiarity with supplier quality management, product development lifecycle, and post-market quality engineering (complaints, CAPA, reliability engineering). Core Competencies & Skills · Strong knowledge of root cause analysis, CAPA management, and risk analysis tools (FMEA, Fault Tree, etc.). · Ability to mentor and develop engineers, ensuring alignment with compliance and continuous improvement objectives. · Excellent communication skills, able to work with both technical staff and executive leadership. · Proficiency in quality system software, data analysis tools, and project management. Working conditions
Must be willing to work weekends and evening hours as necessary. Must be willing to accommodate travel if necessary. The job may require work to be performed inside the controlled cleanroom manufacturing area where the engineer would be exposed to tissue processing. Physical requirements
While performing the duties of this job, the employee is regularly required to sit for prolonged periods of time. The employee may occasionally be required to pull, lift and/or move objects weighing up to 30 pounds. Direct reports
Quality Engineers Quality Assurance Coordinators Nothing in this job description restricts management’s right to assign or reassign duties and responsibilities to this job any time. Vivex is an equal opportunity employer (EEO) and expressly prohibits any form of workplace discrimination and/or harassment based on , , , , , or expression, , , genetic information, , or veteran status. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, transfers, leaves of absence, compensation and training. Vivex complies with the Americans with Act (ADA) which prohibits discrimination against qualified individuals with disabilities who, with or without reasonable accommodation, can perform the essential functions of a job.
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