Director Quality Systems

3 weeks ago

Sunnyvale, United States Intuitive Surgical Full time
Job Description

Primary Function of Position
The Director, Quality Systems will be a key member of the Quality Systems and Compliance leadership team with broad responsibilities. The successful candidate will help to create a quality management infrastructure that is compliant, effective, efficient and agile and that supports a rapidly growing international business model with complex and diverse product lines. S/he will provide quality management oversight for elements of the Intuitive Surgical Quality Management System (QMS), which includes design controls, corrective and preventive action, training, document controls, production and process controls, facilities and equipment controls, and material controls through to GMP for all aspects including identification and escalation of quality system and product issues. Provide strategic guidance regarding the establishment and monitoring of quality metrics for executive review to determine health of QMS and lead the team in continuous improvement and planning for growth activities as needed. S/he will grow, develop and manage team to interface and support all regulatory compliance requirements of the company.

Essential Job Duties

  • Establish programs, guidelines and procedures related to areas of responsibility to include but not limited to Quality systems including Change Control, Data and Document Management and Records Management and Compliance Training
  • Working with Learning Management staff to develop and deploy an optimized compliance training program and monitoring.
  • Working with cross functional leadership to implement best practices for change control documents and records management.
  • Working with Heads of RAQA APAC and RAQA EMEA to ensure international quality systems are compliant and effective for local, regional and corporate business needs as well as regional regulatory requirements.
  • Responsible for assisting in management of regulatory inspections/external audits and related compliance activities. Support internal audits execution and related findings.
  • Working with Head of Audit, help define programs that ensure the verification and monitoring of the effectiveness of the quality system and its compliance to applicable regulations and standards.
  • Working with Head of RAQA Operational Excellence, help define the Quality Systems improvement strategy that includes responsibilities for development, implementation and the continuous improvement of ISI quality system(s).
  • Provide training and consulting to internal customers on quality system regulatory compliance.
  • Partner across the company to drive standardization of Quality Systems.
  • Establish programs to effectively monitor and assess the global quality system through key performance indicators, metrics and scorecards.
  • Work to ensure the timely identification, escalation and corrective actions resulting from Management Review and Quality System reviews.

  • Director Quality Systems

    3 weeks ago

    Sunnyvale, California, United States Intuitive Surgical Full time

    Job DescriptionPrimary Function of Position The Director, Quality Systems will be a key member of the Quality Systems and Compliance leadership team with broad responsibilities. The successful candidate will help to create a quality management infrastructure that is compliant, effective, efficient and agile and that supports a rapidly growing international...

  • Quality System Specialist

    3 weeks ago

    Sunnyvale, California, United States AGCO Full time

    Title: Quality System Specialist Location: Sunnyvale, CA (Hybrid or Onsite) OR US remote Are you passionate about setting the gold standard for quality in a dynamic environment? We are on the lookout for an enthusiastic individual to lead the establishment of our Quality Management System (QMS). If you thrive on crafting efficient processes, ensuring...

  • Director, Systems Engineering, Spacecraft Engine

    4 weeks ago

    Sunnyvale, California, United States Astra Space Inc Full time

    Astra delivered its first commercial launch to low Earth orbit in 2021, making it the fastest company in history to reach this milestone, just five years after it was founded in 2016.As the Director of Systems Engineering for Astra's Spacecraft Engines Program, you will lead and oversee the systems engineering and propulsion team responsible for the design,...

  • Manager Quality Engineering

    4 weeks ago

    Sunnyvale, California, United States Intuitive Surgical Full time

    Job DescriptionPrimary Function of Position: This person leads and functionally manages the Quality Engineering group. You will interface with leaders including VPs and Directors throughout the design, operations, regulatory, IT, marketing and service areas of Intuitive Surgical. Quality Engineering is primarily responsible for measuring quality and helping...

  • Dental Director

    7 days ago

    Sunnyvale, United States PREMISE HEALTH Full time

    Healthcare Without Rival Premise Health is the world's leading direct healthcare provider and one of the largest digital providers in the country, serving over 11 million eligible lives across more than 2,500 of the largest commercial and municipal employers in the U.S. Premise partners with its clients to offer fully connected care - in-person and in the...

  • Sr Director Global Indirect Procurement

    1 week ago

    Sunnyvale, California, United States Intuitive Surgical Full time

    Job DescriptionPrimary Function of Position: The Senior Director, Global Indirect Procurement & Vendor Management is expected to drive cost savings through leveraging our worldwide spend and negotiations with vendors, drive efficiency in our indirect procurement operations, minimize the efforts of Company stakeholders in procuring goods and services and...

  • Sr Director Global Indirect Procurement

    5 days ago

    Sunnyvale, United States Intuitive Surgical Full time

    Job DescriptionPrimary Function of Position: The Senior Director, Global Indirect Procurement & Vendor Management is expected to drive cost savings through leveraging our worldwide spend and negotiations with vendors, drive efficiency in our indirect procurement operations, minimize the efforts of Company stakeholders in procuring goods and services and...

  • Manager, Product Quality

    4 weeks ago

    Sunnyvale, United States Thermo Fisher Scientific Full time

    When you’re part of the team at Thermo Fisher Scientific, you’ll do important work, like helping customers in finding cures for cancer, protecting the environment or making sure our food is safe. Your work will have real-world impact, and you’ll be supported in achieving your career goals. **Location/Division Specific Information**: Sunnyvale,...

  • Quality Engineer 3

    4 weeks ago

    Sunnyvale, United States Intuitive Surgical Full time

    Job DescriptionPrimary Function of Position:As Intuitive’s da Vinci® Surgical System becomes adopted by an increasing population of hospitals, surgeons and patients, we are building a focused team to drive reliability, quality, and safety to ever-better levels. This focus applies to product in use, product in manufacturing, and product in design. Help us...

  • Product Quality Engineer

    3 weeks ago

    Sunnyvale, United States Meta Inc Full time

    Meta Reality Labs is building tools that help people feel connected, anytime, anywhere. We are looking for a product quality engineer to help us to build next generation Portal products.Product Quality Engineer ResponsibilitiesUS based owner of Product Quality and Quality Systems for a consumer electronics product line.Lead the quality control system setup...

  • Quality Engineer 3

    7 days ago

    Sunnyvale, California, United States Intuitive Surgical Full time

    Job DescriptionPrimary Function of Position:As Intuitive's da Vinci Surgical System becomes adopted by an increasing population of hospitals, surgeons, and patients, we are building a focused team to drive reliability, quality, and safety to ever-better levels. This focus applies to product in use, product in manufacturing, and product in design. Help us...

  • Director Industrial Engineering

    4 weeks ago

    Sunnyvale, United States Intuitive Surgical Full time

    Job DescriptionThe Director, Industrial Engineering (IE)will be a key member of the New Product Introduction (NPI) Manufacturing Operations leadership team with broad responsibilities including developing a vision and strategy for IE within Intuitive, hire, coach and mentor IE Managers and team members, foster a continuous improvement culture, while...

  • Director Industrial Engineering

    4 weeks ago

    Sunnyvale, California, United States Intuitive Surgical Full time

    Job DescriptionThe Director, Industrial Engineering (IE)will be a key member of the New Product Introduction (NPI) Manufacturing Operations leadership team with broad responsibilities including developing a vision and strategy for IE within Intuitive, hire, coach and mentor IE Managers and team members, foster a continuous improvement culture, while...

  • Quality Engineer 3

    2 weeks ago

    Sunnyvale, United States Intuitive Surgical Full time

    Job DescriptionPrimary Function of Position:As Intuitive's da Vinci® Surgical System becomes adopted by an increasing population of hospitals, surgeons, and patients, we are building a focused team to drive reliability, quality, and safety to ever-better levels. This focus applies to product in use, product in manufacturing, and product in design. Help us...

  • Product Quality Engineer

    4 hours ago

    Sunnyvale, United States META Full time

    Meta Reality Labs is building tools that help people feel connected, anytime, anywhere. We are looking for a product quality engineer to help us to build next generation Portal products. Product Quality Engineer Responsibilities US based owner of Product Quality and Quality Systems for a consumer electronics product line. Lead the quality control system...

  • Manager, IT Computer Systems Validation

    1 week ago

    Sunnyvale, United States Intuitive Surgical Full time

    Job DescriptionPrimary Function of Position:The Manager of IT CSA drives quality transformation and system validation programs using risk-based approach. Expertise in managing IT GxP systems and leadership in GMP validation for Pharma/biotechnology/medical devices. This critical role ensures GMP compliance and works with Business/Owners and Quality teams to...

  • Manager, IT Computer Systems Validation

    1 week ago

    Sunnyvale, United States Intuitive Surgical Full time

    Job DescriptionPrimary Function of Position:The Sr. Manager of IT CSA drives quality transformation and system validation programs using risk-based approach. Expertise in managing IT GxP systems and leadership in GMP validation for Pharma/biotechnology/medical devices. This critical role ensures GMP compliance and works with Business/Owners and Quality teams...

  • Manager, IT Computer Systems Validation

    2 weeks ago

    Sunnyvale, California, United States Intuitive Surgical Full time

    Job DescriptionPrimary Function of Position:The Manager of IT CSA drives quality transformation and system validation programs using risk-based approach. Expertise in managing IT GxP systems and leadership in GMP validation for Pharma/biotechnology/medical devices. This critical role ensures GMP compliance and works with Business/Owners and Quality teams to...

  • Manager, IT Computer Systems Validation

    2 weeks ago

    Sunnyvale, California, United States Intuitive Surgical Full time

    Job DescriptionPrimary Function of Position:The Sr. Manager of IT CSA drives quality transformation and system validation programs using risk-based approach. Expertise in managing IT GxP systems and leadership in GMP validation for Pharma/biotechnology/medical devices. This critical role ensures GMP compliance and works with Business/Owners and Quality teams...

  • Art Director/graphic Designer

    4 weeks ago

    Sunnyvale, United States Intellipro Group Inc Full time

    **Job title: Art Director / Graphic Designer** **Location: Sunnyvale, CA (Hybrid)** **Pay rate - $51/hr on W2** **Duration - 12+ months contract with possibility of extension** **Primary Function of Position**: **Roles & Responsibilities**: - Produce and edit images to be used in the instructions for use (IFU) for medical device systems and...