Quality Systems Specialist II

Cirtec-Medica; Santa Clara (CA); On-site; USD 84,000 - 100,000; Full time

Job summary

Cirtec Medical Corporation is seeking a Quality Systems Specialist II to ensure adherence to the QMS within Quality Systems & Control. You will coordinate NCMR, CAPA, and complaint processes while supporting investigations and root cause analysis, partnering across R&D, Manufacturing and QA, and maintaining essential quality documents.

The role emphasizes training, process improvements, and compliance with GMP/ISO standards to sustain product quality for Class II/III devices.

Qualifications

• 2+ years of relevant experience in a regulated manufacturing environment.
• Experience analyzing data for patterns and trends.
• Familiarity with GMP/ISO standards.
• Strong English verbal and written communication skills.
• Proficient with Microsoft Office (Outlook, Word, Excel, PowerPoint).
• Able to read, write and speak fluent English.

Responsibilities

• Initiate, own, and/or close Nonconforming Material Reports (NCMRs).
• Initiate or support investigation/analysis of returned/complaint materials.
• Coordinate activities related to NCM, Complaint, RMA, and CAPA processes.
• Support investigation and root cause analysis of advanced/complex issues.
• Escalate material nonconformances to CAPA based on trending data.
• Communicate product performance via formal presentations to management committees.
• Maintain quality system documents related to NCMR, CAPA, and Complaint systems.
• Initiate or review document changes including quality procedures.
• Review quality documentation and records and update as required.
• Adhere to Cirtec Medical policies and procedures.
• Complete assigned tasks with minimal supervision.
• Respond and adapt to changing priorities with minimal disruption.
• Act as a CAPA Owner or support CAPA activities.
• Provide support to the Supplier Quality management group as needed.
• Support internal and external audits.
• Ensure adherence to training requirements for QMS elements, controls, processes, and procedures.
• Provide training on NCM Control, CAPA, etc.
• Support Corporate Quality Management System initiatives and continuous improvement.
• Calculate or monitor key quality metrics.
• Ensure compliance with regulatory standards.
• Ensure site personnel compliance with QMS training.
• Must be knowledgeable of Cirtec Medical QMS and requirements.
• Meet Cirtec training requirements.
• Follow PPE guidelines.

Skills

Data pattern analysis

Cross-functional teams

English communication

Self-starter

GMP/ISO knowledge

Education

Associates of Science Degree in Manufacturing, Engineering, or Technical Field

Tools

PowerBI

Job description

Description

About us:

For over three decades, Cirtec Medical has been a leading outsourcing partner for complex medical devices. We specialize in providing comprehensive solutions for Class II and III devices, from design and development to precision components and finished device assembly. Our expertise spans neuromodulation, implantable drug delivery, cardiac rhythm management, structural heart, mechanical circulatory support, and minimally invasive surgical systems.

Our dedicated teams prioritize growth, innovation, and collaboration. We actively seek opportunities for improvement to enhance our support for clients. If you embrace a growth mindset and thrive on challenges, you may be a perfect fit for our team!

Position Summary:

The Quality Systems Specialist II is responsible for ensuring operations adherence and compliance to Cirtec Medical's Quality Management System (QMS) requirements. Ensures compliant execution and coordination of system elements within the Quality Systems & Control functions team.

Key Responsibilities:

• Initiate, own, and/or close Nonconforming Material Reports (NCMRs).
• Initiate or Support investigation/analysis of returned/complaint materials.
• Coordinate activities related to NCM, Complaint, RMA, and CAPA processes.
• Support investigation and root cause analysis of advanced/complex issues.
• Escalate material nonconformances to CAPA system based on trending and monitoring analysis.
• Communicate product performance by formal presentations to management committees.
• Maintain quality system documents related to NCMR, CAPA, and Complaint systems.
• Initiate or review document changes including quality procedures.
• Review quality documentation and records and update as required.
• Consistently abides by and conforms to all established Cirtec Medical policies and procedures.
• Complete assigned tasks while operating independently and/or with minimal supervision.
• Respond and adapt to changing priorities with minimal disruption.
• Act as a CAPA Owner or support CAPA activities, as necessary, driving corrections and corrective actions to successful completion.
• Provide support to the Supplier Quality management group as needed.
• Provide support during internal audit and external audits.
• Ensure adherence to training requirements regarding Quality Management System elements, controls, processes, and procedures.
• Provide training, as needed, to individuals or groups on NCM Control, CAPA, etc.
• Support Corporate Quality Management System initiatives and continuous improvement activities.
• Calculate or monitor key quality metrics.
• Ensure compliance to regulatory standards and requirements as applicable.
• Ensure compliance of all site personnel to Corporate and site-level QMS and functional training requirements.
• Must be knowledgeable of, and adhere to, the Cirtec Medical Quality Management System and its requirements.
• Must be able to successfully meet Cirtec Medical-specific positional/functional on-the-job training requirements as provided .
• Must follow occupational Safety and Health requirements including Personal Protective Equipment (PPE) guidelines and rules.

Must Have:

• Associates of Science Degree in Manufacturing, Engineering, or Technical Field, or equivalent of directly transferrable industry work experience.
• Experience examining the data for patterns and trends and working on cross-functional teams.
• A minimum of 2 years of relevant experience in a regulated manufacturing environment required.
• Knowledge of, and experience with, GMP/ISO Standards.
• Strong verbal and written English language communication skills.
• Must demonstrate ability and/or experience in computer use and general office software - Microsoft Office (i.e., Outlook, Word, Excel, and PowerPoint).
• "Hands-on" self-starter with ability to work both independently and as part of a team.
• Must be able to read, write and speak fluent English.
• Ability to work with a wide variety of functional areas, including R&D, Manufacturing, and QA, as required accomplishing results with minimal guidance.

Nice to Have:

• Advanced Post-Secondary Education/Training/Certification coursework (Manufacturing or Engineering discipline preferred) preferred.
• Quality certification(s) (e.g., ASQ CQT, CQI, etc.) preferred.
• Class I, II and/or III Medical Device manufacturing experience preferred or other regulated manufacturing industry experience (e.g., Aerospace, Automotive, Defense, Pharmaceutical, etc.).
• Experience working with PowerBI

Salary Range:

The pay range for this role is $84,000 - 100,000 a year. The successful candidate's starting base pay will be determined based on job-related skills experience qualifications work location and market conditions. The expected base pay range for this role may be modified based on market conditions.

Cirtec Medical Corporation considers for employment and hires qualified candidates without regard to age, race, religion, color, sex, sexual orientation, gender identity, national origin, ancestry, protected veteran or disability status or any factor prohibited by law. Cirtec Medical Corporation and all of its related companies fully endorse equal opportunity for all. Cirtec Medical provides reasonable accommodation for qualified individuals with disabilities and disabled veterans in the job application process.

We work to create a culture that is built on innovation, respect, transparency and communication, and hope you take pride in being a member of our team. It is Cirtec’s goal to create a great work environment and to keep the company a great place to work. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage. Our benefits include Training and career development, Healthcare and well-being programs including medical, dental, vision, wellness and occupational health programs, Paid Time Off and 401(k) retirement savings with a company match.

We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.