Quality Systems Specialist II

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

Responsible for ensuring the proper implementation, maintenance, and operational compliance with Cirtec Medical's Quality Management System (QMS) requirements, ensuring the effective execution, coordination, and alignment of system elements within the Quality Systems team and Control functions.

Key Responsibilities

Initiate, develop, and/or close Nonconforming Material Reports (NCMRs).
Initiate or support the investigation and analysis of returned materials or complaints.
Coordinate activities related to NCMR, Complaint, and CAPA processes.
Support the investigation and root cause analysis of advanced or complex issues.
Escalate material nonconformities to the CAPA system based on trend analysis and monitoring.
Communicate product performance through formal presentations to management committees.
Maintain quality system documentation related to NCMR, CAPA, and complaint systems.
Initiate or review document changes, including quality procedures.
Review quality documentation and records and update them as necessary.
Consistently comply with all established Cirtec Medical policies and procedures.
Complete assigned tasks while operating independently and/or with minimal supervision.
Respond to and adapt to changing priorities with minimal disruption.
Act as CAPA owner or support CAPA activities as required, driving corrections and corrective actions to successful completion.
Provide support to the Supplier Quality Management group as needed.
Provide support during internal and external audits.
Ensure compliance with training requirements related to Quality Management System elements, controls, processes, and procedures.
Provide training, as needed, to individuals or groups on NCMR control, CAPA, etc.
Support Corporate Quality Management System initiatives and continuous improvement activities.
Calculate or monitor key quality metrics.
Ensure compliance with applicable standards and regulatory requirements.
Ensure site personnel compliance with corporate Quality Management and site-level functional training requirements.
Be knowledgeable of and comply with Cirtec Medical's Quality Management System and its requirements.
Successfully complete position-specific/functional on-the-job training requirements at Cirtec Medical, as provided.
Comply with Occupational Health and Safety requirements, including Personal Protective Equipment (PPE) guidelines and standards.
Comply with company quality and safety standards, policies, and procedures.
Perform other duties as assigned.

Must Have

Bachelor's degree in Industrial Engineering, Quality, Process Engineering, or equivalent directly transferable work experience in the medical industry (Engineering or Quality discipline preferred).
Experience analyzing data to identify patterns and trends and working within cross-functional teams.
A minimum of 2 years of relevant experience in a regulated manufacturing environment is required.
Quality certifications preferred (e.g., ASQ CQT, CQI, etc.).
Preferred experience in the manufacturing of Class I, II, and/or III medical devices, or in other regulated manufacturing industries (e.g., aerospace, automotive, defense, pharmaceutical, etc.).
Knowledge of and experience with GMP and ISO standards.
Strong verbal and written communication skills in English.
Demonstrated proficiency and/or experience using computers and general office software, including Microsoft Office (Outlook, Word, Excel, and PowerPoint).
Hands-on, self-motivated individual with the ability to work independently and as part of a team.
Ability to work effectively across a wide range of functional areas, including R&D, Manufacturing, and Quality Control, as required, achieving results with minimal direction.
High level of English.

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.
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