DescriptionPosition 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 abide 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.
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.
