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Quality Systems Manager
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#487939
Full Time
Job Description
Hiring: Quality Systems Manager
In person position in Pleasanton, CA with the option of hybrid work
Salary: $150-170k with full benefits
Apply instructions: Please send a cover letter or quick intro about yourself and resume to Kim at [email protected]
Primary responsibility will be to ensure compliance and scope of the lean quality management system (QMS) in alignment with the strategic direction of the organization for the devices and products produced, and customers and markets served. To ensure necessary systems have been established to ensure devices and products are manufactured in compliance with customer, QMS, and regulatory/statutory requirements.
Job Functions:
· Hands-on managerial role responsible for facilitating efforts to analyze, define, plan, implement, maintain, and continuously improve the Quality System in accordance with compliance requirements, risk management, and the strategic needs of the business including:
o Document, design, supplier, process, CAPA, equipment, management control processes
o Complaint handling, audit, training, and nonconforming material requirements processes
o To guide and direct design control team throughout the process
· Facilitate the incorporation of applicable quality systems/regulatory requirements and updates in accordance with the current interpretation of 21 CFR 820, 21 CFR Part 11, 801, 803, 806, 807 and ISO 13485 and ISO 14+71. Experience with EU MDR 2017/745 preferred.
· Analyze, develop, and maintain key metrics for trends indicating the effectiveness and suitability of the QMS and identify areas for improvement.
· Emphasize the awareness of quality system requirements, processes, and deliverables throughout the organization and support the development of a proactive and preventive quality systems culture throughout the business.
· Provide practical, useful, and efficient quality systems reports for senior management, management reviews, business strategic initiatives, and specific requests.
· Provide leadership and direct management of associates while providing support for global quality systems initiatives.
Qualifications:
· 4-year degree required, preferably in Engineering or Life Sciences, graduate degree desired
· Min 5 years’ experience in a med device company or equivalent experience in another highly regulated industry
· Quality/regulatory certifications ASQ, RAC, Lead Auditor, and/or Lean Six Sigma preferred
· Proficient in MS365, Visio, Adobe Acrobat, eQMS software, SolidWorks, and other software; US and most OUS regulations
· Strong interpersonal skills and ability to clearly communicate (both verbal and written) with all levels of the organization and regulators
· Strong proofreading skills and organizational skills, as well as exemplary attention to detail
· Demonstrated initiative and ability to work independently while handling multiple tasks
· Strong decision-making skills and level of understanding to pace work in a rapidly growing company
In person position in Pleasanton, CA with the option of hybrid work
Salary: $150-170k with full benefits
Apply instructions: Please send a cover letter or quick intro about yourself and resume to Kim at [email protected]
Primary responsibility will be to ensure compliance and scope of the lean quality management system (QMS) in alignment with the strategic direction of the organization for the devices and products produced, and customers and markets served. To ensure necessary systems have been established to ensure devices and products are manufactured in compliance with customer, QMS, and regulatory/statutory requirements.
Job Functions:
· Hands-on managerial role responsible for facilitating efforts to analyze, define, plan, implement, maintain, and continuously improve the Quality System in accordance with compliance requirements, risk management, and the strategic needs of the business including:
o Document, design, supplier, process, CAPA, equipment, management control processes
o Complaint handling, audit, training, and nonconforming material requirements processes
o To guide and direct design control team throughout the process
· Facilitate the incorporation of applicable quality systems/regulatory requirements and updates in accordance with the current interpretation of 21 CFR 820, 21 CFR Part 11, 801, 803, 806, 807 and ISO 13485 and ISO 14+71. Experience with EU MDR 2017/745 preferred.
· Analyze, develop, and maintain key metrics for trends indicating the effectiveness and suitability of the QMS and identify areas for improvement.
· Emphasize the awareness of quality system requirements, processes, and deliverables throughout the organization and support the development of a proactive and preventive quality systems culture throughout the business.
· Provide practical, useful, and efficient quality systems reports for senior management, management reviews, business strategic initiatives, and specific requests.
· Provide leadership and direct management of associates while providing support for global quality systems initiatives.
Qualifications:
· 4-year degree required, preferably in Engineering or Life Sciences, graduate degree desired
· Min 5 years’ experience in a med device company or equivalent experience in another highly regulated industry
· Quality/regulatory certifications ASQ, RAC, Lead Auditor, and/or Lean Six Sigma preferred
· Proficient in MS365, Visio, Adobe Acrobat, eQMS software, SolidWorks, and other software; US and most OUS regulations
· Strong interpersonal skills and ability to clearly communicate (both verbal and written) with all levels of the organization and regulators
· Strong proofreading skills and organizational skills, as well as exemplary attention to detail
· Demonstrated initiative and ability to work independently while handling multiple tasks
· Strong decision-making skills and level of understanding to pace work in a rapidly growing company
