Intuitive Surgical Careers

Director, Quality Systems

US-CA-Sunnyvale, California
Regulatory and Quality


Job Description

Job: Regulatory and Quality
Primary Location: United States-California-US-CA-Sunnyvale
Schedule: Full-time
Requisition ID: 183535

Description

Company Description:

Who is Intuitive Surgical? The numbers tell an amazing story. Learn more about our company.

 

Joining Intuitive Surgical means joining a team dedicated to using technology to benefit patients by improving surgical efficacy and decreasing surgical invasiveness, with patient safety as our highest priority.

Primary Function:


The Director of Quality Systems will be a high-energy, results oriented, key member of the Quality Systems and Compliance leadership team with diverse responsibilities. The successful candidate will be an accomplished leader, experienced in regulated industries within a global corporate environment. An expectation is that this individual drive strategic quality initiatives for corporate and global sites while providing leadership for the teams that support the quality management system/infrastructure to maintain a compliant, effective, efficient and agile system. S/he will provide leadership for all elements of the Intuitive Surgical Quality Management System (QMS) to support a rapidly growing international business model with complex and diverse product lines. Will provide strategic guidance regarding the establishment and monitoring of quality metrics for executive review to determine health of QMS and lead team in continuous improvement or scalability activities as needed. Will have extensive, global experience in hosting and managing facility inspections and audits required by government or regulatory agencies.

H/She will be a motivated leader who is passionate about coaching and leading high performing teams; and has a strong record of accomplishment for successfully executing strategic initiatives through collaboration with key stakeholders (and leadership of the QS team) to bring measurable and significant impact to the organization.

Roles and Responsibilities:


- Serves as the QS Leader, responsible for establishing and maintaining the global compliance program to ensure compliance with global regulatory requirements, international standards, company policies and procedures.
- Functions as the Quality Ambassador with Executives and Key Stakeholders for the deployment of Corporate and Global Strategic Quality Initiatives.
- Drives the Quality Planning and Quality Objectives process ensuring effective deployment and monitoring. Establishes programs to effectively monitor and assess the global quality system through metrics and scorecards.
- Provides leadership for the establishment, improvement, and maintenance of programs that ensure the verification and monitoring of the effectiveness of the quality system and its compliance to applicable regulations and standards.
- Provides direction on optimization of programs, guidelines and procedures related to areas of responsibility to include but not limited to Management Review, CAPA, Non-conformances, Quality Systems Review, Quality Planning, Quality Objectives, Analytics and Quality Scorecard, Change Control, Data and Document Management, Records Management and Training Management.
- Leads Quality Systems improvement strategy that includes responsibilities for development, implementation and optimization of the ISI quality system.
- Serves as the lead coach/consultant to educate internal customers on quality systems and regulatory compliance.
- Analyzes quality data and provides compliant, pragmatic guidance to support Regulatory Compliance activities including quarterly Quality Review Board Meetings, responses to agency requests for information and analyses to support quality improvement projects.
- Collaborates with Regulatory Compliance to oversee the Management Review process to ensure linkage of all ISI sites and provides reviews and visibility to Senior Management; including timely identification and escalation of emerging issues resulting from Management Review and Quality System review.
- Collaborates with Regulatory Compliance to manage, schedule and host regulatory inspections (internal and external) and related compliance activities.

Qualifications

Competency – Education, Experience, Training & Skills:


- Education – A minimum of a Bachelor’s Degree in Engineering or Science is required.


- Experience/Training – A minimum of 10 years’ experience in a Medical Device or other regulated industry, with a minimum of eight recent years in a quality assurance or compliance role is required.

o Proficient in domestic and external regulations and standards (e.g., 21 CFR Part 820/801/803/806/830, ISO 13485:2016, ISO 14971, SOR/98-282 (Canada), RDC 16/2013 (Brazil/ANVISA), MDD - Medical Device Directive)
o Six Sigma Green or Black Belt certification or company sponsored process excellence training is highly preferred.
o RAC certification, ASQ - CMQ/OE, CQA, CQE, and/or ISO Lead Assessor is desirable.

- Skills – Strong, demonstrated strategic and global leadership within a corporate environment is required to ensure alignment of priorities and effective execution of global initiatives.

o Subject Matter Expert in leading and hosting external regulatory body audits.
o Strong emotional intelligence to enable successful interface and partnership with teams, key stakeholders, executives, and regulatory agency representatives.
o Demonstrated strong leadership and interpersonal skills with a passion for developing teams and people to their highest potential is required.
o Adept in leading through influence and negotiation to ensure proper execution and clear/concise communication.
o Skilled in Risk Management methodology and the product lifecycle (design to post market surveillance).
o A working knowledge of project management tools and techniques is required.

We are an AA/EEO/Veterans/Disabled employer.
We will consider for employment qualified applicants with arrest and conviction records in accordance with fair chance laws.