Quality Inspection Failure Analysis

2 months ago

Southaven, United States Intuitive Full time
Company Description

At Intuitive, we are united behind our mission: we believe that minimally invasive care is life-enhancing care. Through ingenuity and intelligent technology, we expand the potential of physicians to heal without constraints.
As a pioneer and market leader in robotic-assisted surgery, we strive to foster an inclusive and diverse team, committed to making a difference. For more than 25 years, we have worked with hospitals and care teams around the world to help solve some of healthcare's hardest challenges and advance what is possible.
Intuitive has been built by the efforts of great people from diverse backgrounds. We believe great ideas can come from anywhere. We strive to foster an inclusive culture built around diversity of thought and mutual respect. We lead with inclusion and empower our team members to do their best work as their most authentic selves.
Passionate people who want to make a difference drive our culture. Our team members are grounded in integrity, have a strong capacity to learn, the energy to get things done, and bring diverse, real world experiences to help us think in new ways. We actively invest in our team members to support their long-term growth so they can continue to advance our mission and achieve their highest potential.
Join a team committed to taking big leaps forward for a global community of healthcare professionals and their patients. Together, let's advance the world of minimally invasive care.

Job Description

Primary Function of Position

The following reflects management's definition of essential functions for this job but does not restrict the tasks that may be assigned. Management may assign or reassign duties and responsibilities to this job at any time due to reasonable accommodation or other reasons.

Proficiently follows oral and/or written instructions in performance of a wide variety of inspections and testing of complex medical instrumentation and documents findings in Quality Management System. Responsible for timely processing and dispositioning of returned instruments and accessories.

Responsible for the timely processing and dispositioning of all RMA's, with focus on Instruments and accessories.

Regularly use of diagnostic software for localizing equipment and system problems, specialized testing equipment, analyzers, digital oscilloscopes, digital multimeters, clocks, timers, calipers, voltmeters, power supplies, rulers, and other test equipment as required.

Essential Job Duties
  • Perform failure analysis of defective instruments and accessories by evaluating the mechanical, electrical, and physical characteristics of returned items.
  • Perform Disposition of Excess and System Trade in RMA I&A returns
  • Documenting failure analysis findings in clear and concise way in QMS system
  • Assist Advance FA team on regulatory requirements in resolving "Reportable I/A" events and "Recalled" instruments.
  • Regular communication with failure analysis engineering group and post market surveillance
  • Able to perform Failure analysis of Core instrumentation and accessories.
  • Able to resolve minor to moderate problems without assistance
  • Builds important internal/external relationships through advanced communication skills; knows how to influence and negotiate effectively through communications.
  • Mentors new team members as needed.
  • Ability to verify assembly documentation accuracy, read engineering drawings etc. Sets up and operates machines/equipment /fixtures needed to perform inspection and testing processes.
  • Understands diagrams, schematics, assembly drawings, fab drawings, mechanical component drawings.
  • Recommend/implements RMA process workflow improvements.
  • Disposes bio-hazardous material as required.
  • Performs "Purging tasks" for all the completed RMA's if applicable.
  • Maintains knowledge of DOP's, SOP's and MPI's pertaining to I/A RMA operations.
  • Works independently towards daily and throughput targets.
  • Follows all corporate, safety, SOP, DOP procedures and regulations.
  • Maintains a clean and orderly work area.
Qualifications

Required Education, Skills, and Training
  • Education and/or Experience: Minimum High school diploma and AA or equivalent Minimum of AA or college degree preferred; 2-4 years related experience or training; or equivalent combination of education and experience.
  • Language Skills: Ability to read, write and understand English. Ability to read and understand work instructions.
  • Mathematical Skills: Ability to do basic math.
  • Reasoning Ability: Ability to apply rational, sensible understanding to carry out instructions. Ability to deal with situations including up to several variables. Ability to report actual or potential quality issues. Ability to suggest and implement process improvements.
  • Computer skills: Proficient in use of personal computers as part of daily work, including knowledge of the Microsoft Office suite and SAP ERP System, ACCS (Agile) system (our quality system) to retrieve and submit on-line documentation.
  • Ability to communicate effectively with technical and non-technical internal customers.
  • Acute attention to detail; excellent organizational skills.
  • High level of professional integrity and ethics
  • Ability to work varying shifts.
  • Must have ability to complete training courses.
  • Ability to work in a team environment.
Working Conditions
  • Ability to lift 50lbs.
  • Able to use office and test equipment in a typical office/light manufacturing environment.
  • Repetitive motion. Substantial continual motion.
  • Excellent hand-eye coordination.
  • Vision abilities required include close, distance, color, depth and ability to adjust focus.
Work Environment:
  • Typical production & repairs environment.
  • General knowledge of clean and organized work areas and practices.
  • High urgency and stress associated with customer deadlines.
  • Some work in controlled environment with handling of unsterilized medical instrumentation
  • Some risk of exposure to electrical shock and commonly used chemical compounds such as epoxy, denatured alcohol and acetone.
  • General knowledge of PPE usage
  • Willing and able to work extended hours when necessary.


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 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.

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 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.

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.

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