Director of Quality - Malaysia Operations

Job Description

Primary Function of Position:

Under general supervision and in alignment with the Sr. Director of Quality Operations for Sunnyvale and Europe, defines and executes sites strategies to  assure compliance  to the quality system and international regulations of the medical industry by managing the quality operations and quality engineering teams and in collaboration with all local and corporate functions  to guarantee and maintain the quality of manufacturing processes, finished product and regulatory compliance.

Roles & Responsibilities:

• Direct responsibility for the Malaysia Operations at Penang. Responsible for the quality functions including IQC, MRB, PMC, FQI, DHR and Quality Engineering.
• Develops site and regional strategies to ensure alignment with our company goals and customer expectations, pursuing continuous improvement in our metrics.
• Creates an environment that is inclusive and diverse allowing employees to be their authentic selves, while motivating them to produce their best work.
• Fosters an inclusive culture built around diversity of thought, collaboration and teamwork across organizational and geographical boundaries; willing to break down functional silos to optimize business results and to facilitate the overall growth of the company.
• Proactively manages quality assurance and compliance activities to produce the highest quality products and prevent defects.
• Create, monitor, and control the quality operations budget for the facilities under responsibility.
• Collaborates with the operations teams as well as other internal and external partners to ensure the strategy is executed to achieve significant and measurable results.
• Track recurring issues and escalate as needed to achieve root cause corrective action.
• Collect, monitor, and escalate product quality data and partner with the appropriate function to resolve problem parts, supplier, processes, etc. to closure.
• Develop, trend, and improve appropriate quality operational metrics.
• Provides support and guidance to lead adhering to our internal procedures and regulatory requirements.
• Performs Organization Talent Plans to assure the identification of talent needs and the development of adequate growth plans.
• Plans resource requirements based on the company growth projections and long-term strategies.

Qualifications

Skills, Experience, Education, & Training:

• Education: Professional Career Electronics, Biomedical, Industrial or other related engineering
• Other studies: Certification in Six Sigma Desirable, MBA desirable, Certified Lead Auditor desirable
• English language skills: 100% Written and spoken, German 100% fluency highly desirable
• Systems Management:
  • Office Package Advanced level
  • SAP Intermediate level
  • Agile preferably Intermediate level
• Job or area experience:
  • Quality Director/manager 5 years
  • Have worked in Quality areas 8 years
  • Have worked in the medical industry 12 years
• Knowledge / skills:
  • Knowledge of Statistical Tools such as MSA (Measurement System Analyst) 5 years
  • Knowledge of ISO 13485 5 years
  • Knowledge of medical regulations 5 years
  • Drawings Reading 3 years

Additional Information

Intuitive is an Equal Employment Opportunity Employer. We provide equal employment opportunities to all qualified applicants and employees, and prohibit discrimination and harassment of any type, without regard to race, sex, pregnancy, sexual orientation, gender identity, national origin, color, age, religion, protected veteran or disability status, genetic information or any other status protected under federal, state, or local applicable laws.

We will consider for employment qualified applicants with arrest and conviction records in accordance with fair chance laws.

U.S. Export Controls Disclaimer:  In accordance with the U.S. Export Administration Regulations (15 CFR §743.13(b)), some roles at Intuitive Surgical may be subject to U.S. export controls for prospective employees
who are nationals from countries currently on embargo or sanctions status.

Certain information you provide as part of the application will be used for purposes of determining whether Intuitive Surgical will need to (i) obtain an export license from the U.S. Government on your behalf (note: the government’s licensing process can take 3 to 6+ months) or (ii) implement a Technology Control Plan (“TCP”) (note: typically adds 2 weeks to the hiring process).  

For any Intuitive role subject to export controls, final offers are contingent upon obtaining an approved export license and/or an executed TCP prior to the prospective employee’s
start date, which may or may not be flexible, and within a timeframe that does not unreasonably impede the hiring need. If applicable, candidates will be notified and instructed on any requirements for these purposes. 

This position may be filled at a different job level than listed here depending on
business need and/or on the selected candidate’s experience, knowledge and skills.
Compensation will be based primarily on the job level at which the role is filled and the
candidate’s qualifications, consistent with applicable law.