Manager, Quality Engineering

This person manages and grows a Quality Engineering team that is equipped to reach across the company acting as representatives for the Product Quality mission. This person will focus on single-use and multi-use robotic surgical instruments and accessories. The Intuitive Quality Engineering is responsible for developing quality metrics and helping the company apply them intelligently and consistently. Quality Engineering is broadly responsible for or a stake-holder in Product Quality; Data Quality; Process Quality; Solutions to challenging quality problems; Design for Quality in the new product; Organizational input to QRB; Organization of Enterprise data for quality. The Quality Engineering Manager is responsible for managing the team of Quality Engineers evaluating their results and further develop the team members. They interfaces with leads including VPs and Directors throughout the design operations regulatory IT marketing and service areas of Intuitive Surgical.

Roles & Responsibilities:

• Manage group of Quality Engineers and help them through their day to day responsibilities
• Oversees the preparation of the Quality metrics presentations for QDR / QOR Meetings and studies the data to obtain conclusions to define proper action plans for continuous improvement
• Assess issues and Escalates based on criticality
• Liaison with other Quality functions representatives in other Intuitive locations and with other company functions as it applies
• Represents the Quality Engineering function in projects of medium to high complexity Escalation Processes CAPAs External and Internal audits
• Defines the Quality Engineering organizational structure to provide the required help
• Anticipates future needs in order to adequate the organizational structure according to company growth/changes
• Identifies opportunities for improvements in Product Quality Processes Efficiency Cost Reduction and coordinates the team of QEs for the implementation of these opportunities to achieve our company goals
• Defines and executes the development plans for the Quality Engineering team under her or his responsibility establishing and documenting development goals and tracking its progress
• Serving and proponent for quality across the enterprise
• Providing metrics and guidelines to functions to assist in trending and improving quality
• Applying metrics to measure quality and metrics to trade quality off against other attributes of a successful enterprise (cost of quality)
• Maintaining a prioritized list of quality initiatives on three levels
• Product quality - Investigation of product failures and reliability opportunities; metrics; deep failure analysis; assistance in project management of projects that address said failures; metrics of improvement
• Data quality - Comprehension and investigation (analysist) of how the enterprise acquires and processes raw data to derive action priorities and plans; development of data quality vision and negotiation for the gradual adoption of that vision throughout the enterprise
• This requires an expertise of how IT and Operations manage and input quality data as well as cost-benefit trade-offs for potentially costly perfect data
• Process Quality - examine of processes that affect product quality or guidance to others to examine their processes
• Project management help for a series of Product Compliance and Quality projects
• Helping New Product Introduction initiatives by assessing Quality Engineering resources needed and allocation
• Support for deep technical failure analysis and study of challenging quality issues Generation of input for QRB including managing the quality of other organizations input
• Review of quality data collected regularly and setting of priorities such as Bioburden / Endotoxins and CER performance data trending study review and reporting
• Gathering and making available to enterprise customers a routine set of quality data for their weekly use (standard quality reports)
• Revision and approval of internal documentation including: Engineering Change Orders (ECOs BCOs NCOs MCOs etc.) Work instructions (MPIs IVIs QAPs Acceptance criteria etc.) Operating procedures (SOPs DOPs etc.) Validations (IQ OQ PQ PPQ)
• Take responsibility for developing and maintaining compliance with the quality system
• Review and assign priorities to Quality Engineers when production line help
• is required
• Help on the implementation of assembly lines or product transfers into our facilities including planning validation/verification and final implementation
• Drive our Culture Strategy by fostering our mission founding values individual and leadership expectations.

Qualifications :

Skills Experience Education & Training:

Required:

• Impeccable integrity
• Education: Minimum BS in Engineering degree (Master degree is preferred) or equivalent experience
• Minimum 5 years experience in the quality arena of medical device manufacturing or equivalent quality background experience in complex electro-mechanical devices and single-use devices is preferred
• Proven ability to build and manage teams and to project-manage cross-functionally
• Minimum 2 years experience managing groups of professionals
• Proven analytic skills as proven by track record for reviewing and fixing complex problems in products and processes
• Demonstrate proven leadership skills to coordinate and coach reporting engineers
• Proven ability to manage and motivate across functional boundaries Proven ability to manage through conflicting requirements and make difficult trade-offs when resources are scarce
• A passion for doing the vital thing efficiently and well
• Excellent judgment in the presence of challenging priorities and incomplete data
• Possess proven communication skills to interact with suppliers other departments within the company (Supplier Engineering New Product Introduction Planning Purchasing Regulatory Product Quality etc. in Sunnyvale)

Preferred:

• Minimum MS in an engineering discipline
• Lean Six Sigma training

Additional Information :

Due to the nature of our business and the role please note that Intuitive and/or your customer(s) may require that you show current proof of vaccination against certain diseases including COVID-19. Details can vary by role.

Intuitive is an Equal 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.

We provide market-competitive compensation packages inclusive of base pay incentives benefits and equity. It would not be typical for someone to be hired at the top end of range for the role as actual pay will be determined based on several factors including experience skills and qualifications. The target salary ranges are listed.

Due to the nature of our business and the role please note that Intuitive and/or your customer(s) may require that you show current proof of vaccination against certain diseases including COVID-19.  Details can vary by role.

Intuitive is an Equal 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.

Mandatory Notices

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

Preference will be given to qualified candidates who do not reside or plan to reside in Alabama Arkansas Delaware Florida Indiana Iowa Louisiana Maryland Mississippi Missouri Oklahoma Pennsylvania South Carolina or Tennessee.

We provide market-competitive compensation packages inclusive of base pay incentives benefits and equity. It would not be typical for someone to be hired at the top end of range for the role as actual pay will be determined based on several factors including experience skills and qualifications. The target salary ranges are listed.

Im interested

Due to the nature of our business and the role please note that Intuitive and/or your customer(s) may require that you show current proof of vaccination against certain diseases including COVID-19.  Details can vary by role.

Intuitive is an Equal 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.

Mandatory Notices

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

Preference will be given to qualified candidates who do not reside or plan to reside in Alabama Arkansas Delaware Florida Indiana Iowa Louisiana Maryland Mississippi Missouri Oklahoma Pennsylvania South Carolina or Tennessee.

We provide market-competitive compensation packages inclusive of base pay incentives benefits and equity. It would not be typical for someone to be hired at the top end of range for the role as actual pay will be determined based on several factors including experience skills and qualifications. The target salary ranges are listed.