QMS Developer with Java

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

Intuitive is seeking a highly skilled and experienced Applications Developer specializing in Quality Management Systems (QMS). This role will be accountable for developing, and administering Trackwise EQMS with a specific focus on Java based application development in Post Market Surveillance, Complaints Management, CAPA, Nonconformance, and Regulatory Submissions. Additionally, they will assist with the development of interfaces between the EQMS system and SAP.

Essential Job Duties

1. System Maintenance and Administration:

• Provide development assistance for Trackwise EQMS and other related QMS applications.
• Administer and maintain the functionality of the QMS, ensuring optimal performance and reliability.

2. Requirements Gathering and Analytics:

• Partner with onshore teams and stakeholders to gather business requirements related to QMS functionalities, with a focus on Post Market Surveillance, Complaints Management, CAPA, Nonconformance, and Regulatory Submissions.
• Evaluate and translate business needs into technical specifications for system enhancements.

3. System Development and Customization:

• Develop and implement custom solutions and configurations to enhance the capabilities of the QMS in areas such as Post Market Surveillance, Complaints Management, CAPA, Nonconformance, and Regulatory Submissions.
• Develop and implement custom solutions and configurations to enhance the capabilities of the QMS, specifically in the development of interfaces between EQMS and SAP.
• Utilize SAP ABAP expertise to help the integration between the EQMS system and SAP.
• Partner with development teams to ensure seamless integration of QMS with other business systems.

4. Quality System Compliance:

• Ensure that QMS systems comply with relevant regulatory requirements in the medical device industry, especially in Post Market Surveillance, Complaints Management, CAPA, Nonconformance, and Regulatory Submissions.
• Conduct periodic audits and assessments to verify adherence to quality standards.

5. User Training and Assistance:

• Provide training and help to end-users to ensure effective utilization of QMS systems.
• Troubleshoot and resolve user reported issues in a timely manner.

6. Documentation and Reporting:

• Maintain comprehensive documentation for system configurations, changes, and upgrades, specifically in the context of Post Market Surveillance, Complaints Management, CAPA, Nonconformance, and Regulatory Submissions.
• Generate regular reports on system performance, issue resolution, and compliance metrics.

Qualifications

Required Skills and Experience

• Minimum of 5 years of experience as a Developer/Business Systems Analyst with a focus on QMS in the medical device industry.
• Java Development and SAP ABAP experience is essential for developing EQMS applications and interfaces between EQMS and SAP.
• Expertise in maintaining, developing, and administering TrackWise EQMS and/or similar QMS applications.
• Proven knowledge of regulatory requirements related to Quality Systems in the medical device industry.
• Excellent communication and partnering skills for working with onshore and offshore teams.
• Ability to examine complex business processes and translate them into technical requirements.
• Expertise in Post Market Surveillance, Complaints Management, CAPA, Nonconformance, and Regulatory Submissions.
• Experienced in Post Market Surveillance, Complaints Management, CAPA, Nonconformance, and Regulatory Submissions.
• Must be willing/able to work onsite 2 - 3 days/week at one of our US office locations (Sunnyvale, CA, Peachtree Corners, GA, or Raleigh, NC).  

Required Education and Training

• Bachelor’s degree in Information Technology, Computer Science, or a related field.

Preferred Skills and Experience

• SAP ABAP is desired to help the development of interfaces between the EQMS system and SAP.

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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.

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.