Quality Manager

4 weeks ago


Fremont, United States SlingShot Connections Full time
Job DescriptionJob Description

As the Quality Manager, you will be responsible for overseeing all aspects of the
quality management system to ensure compliance with regulatory requirements and customer
expectations. You will lead a team of quality professionals and collaborate with cross-functional
teams to drive continuous improvement initiatives and maintain the highest levels of quality
throughout the organization.

 

Essential Duties and Responsibilities:
• Manage and oversee the implementation and maintenance of the quality management system,
ensuring compliance with ISO 9001, ISO 13485, and CFR 820
• Lead Management Review meetings, reporting quality data results and providing insights to
senior management to drive strategic decision-making
• Host external audits, including customer audits and regulatory inspections, and ensure timely
resolution of any findings or non-conformities
• Provide leadership and direction to the Quality Engineering, Incoming Inspection, and
• Quality Control teams, ensuring effective management of resources and adherence to quality
standards
• Serve as the lead auditor for ISO 9001 and ISO 13485 certifications, conducting internal audits
and leading audit teams to assess compliance and drive improvement
• Liaise with customers to address quality-related inquiries, concerns, and requirements, ensuring
a high level of customer satisfaction
• Collaborate with cross-functional teams to identify and mitigate organizational risks related to
manufacturing processes and product quality
• Provide training and guidance to employees on quality management principles, regulatory
requirements, and best practices
• Stay informed about changes in regulatory requirements and industry standards, and
proactively implement necessary changes to maintain compliance
• Drive a culture of quality excellence and continuous improvement throughout the organization,
leading by example and fostering a collaborative and supportive work environment

 

Minimum Qualifications and Experience:
• Manage and oversee the implementation and maintenance of the quality management system,
ensuring compliance with ISO 9001, ISO 13485, and CFR 820
• Lead Management Review meetings, reporting quality data results and providing insights to
senior management to drive strategic decision-making
• Host external audits, including customer audits and regulatory inspections, and ensure timely
resolution of any findings or non-conformities
• Provide leadership and direction to the Quality Engineering, Incoming Inspection, and Quality
Control teams, ensuring effective management of resources and adherence to quality standards
• Serve as the lead auditor for ISO 9001 and ISO 13485 certifications, conducting internal audits
and leading audit teams to assess compliance and drive improvement

• Liaise with customers to address quality-related inquiries, concerns, and requirements, ensuring
a high level of customer satisfaction
• Collaborate with cross-functional teams to identify and mitigate organizational risks related to
manufacturing processes and product quality
• Provide training and guidance to employees on quality management principles, regulatory
requirements, and best practices
• Stay informed about changes in regulatory requirements and industry standards, and
proactively implement necessary changes to maintain compliance
• Drive a culture of quality excellence and continuous improvement throughout the organization,
leading by example and fostering a collaborative and supportive work environment


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