Job Description:

The Quality Management System (QMS) Manager is a partner for ensuring that the QMS is established and maintained in accordance with applicable regulations, standards and ZEISS global processes at global and assigned local site.

The QMS Manager is responsible for managing the day-to-day operations to implement and maintain effectiveness of the QMS, to support change control and to coordinate the QMS related document services. The QMS Manager is responsible for establishing the regulatory framework for the QMS and for defining and maintaining the tools as required. The QMS Manager will contribute on a cross-functional, global and/or local basis to define, analyze and implement the required compliance and business related QMS procedures and tools.

Job Functions:

• Review compliance of the Quality Management System with applicable state, federal, and international regulations and standards and initiate, implement, and monitor activities to ensure the QMS meets both compliance and business needs

• Lead, mentor and coach process owners, local and global teams to ensure effective change control including implementation, maintenance and improvement of processes, continued compliance and process standardization

• Perform internal audits to demonstrate compliance and effectiveness of the QMS

• Lead and support execution of facility inspections and external audits

• Define direction for ensuring control, transparency and availability of quality system records

• Maintain and improve the infrastructure required for an effective and efficient global QMS

• Participate, and where appropriate, lead global efforts as they relate to the IT systems affecting the QMS and related processes

• Provide related quality management system training

Job Requirements:

• Bachelor’s degree in Quality, Business Administration, Engineering or Scientific field is preferred.

• Minimum of seven (7) years relevant work experience in quality management or regulatory affairs for medical devices.

• Minimum of five (5) years of experience working with quality management systems, including the design and implementation thereof, required.

• Knowledge of regulatory requirements for QMS, including, but not limited to, 21 CFR Part 820 quality systems, Regulation (EU) 2017/745 (MDR) and ISO13485:2016 is required. Broad knowledge of global regulations is preferred.

• Experience in enterprise IT Systems from a QMS perspective. Experience in ERP systems, such as SAP, CRM, Agile and Sharepoint is desired.

• Experience in leadership role is desired.

• Strong Project Management skills.

• Excellent oral and written communication skills.

• Ability to adapt quickly to change and work in a rapidly changing environment.

Job Type: Full-time

Pay: $63,857.72 - $121,683.59 per year

Benefits:

• 401(k)
• Dental insurance
• Employee discount
• Health insurance
• Life insurance
• Paid time off
• Vision insurance

Schedule:

• 8 hour shift
• Day shift
• Monday to Friday

Work Location: Hybrid remote in Dublin, CA 94568

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