Quality Process Specialist

About us:

For over three decades, Cirtec Medical has been a leading provider of manufacturing solutions for complex Class II and III medical devices. We specialize in providing comprehensive services from design and development to manufacturing and finished device assembly. Our expertise spans active implants and neuromodulation, interventional cardiology, structural heart, minimally invasive surgical systems, smart orthopedics, and precision components.

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 challenge, you may be a perfect fit for our team!

Position Summary:

The Quality Process Specialist is responsible for conducting inspections, utilizing statistical process control tools, and ensuring compliance with quality standards throughout the production process. This role involves identifying areas for improvement, investigating non-conformances, and maintaining detailed quality records. Additionally, the specialist collaborates with production, engineering, and quality teams to implement corrective actions and continuous improvements.

Key Responsibilities:

• Conduct regular inspections and testing to identify defects and non-conformances.
• Utilize statistical process control (SPC) tools to analyze data and predict potential quality issues.
• Identify areas for process improvement and implement corrective actions.
• Maintain detailed quality records, generate reports, and document deviations from standards.
• Investigate non-conforming products to determine root causes and develop preventive measures.
• Conduct internal audits to ensure compliance with quality management systems (QMS) and industry standards.
• Provide training on quality standards and procedures to production and quality personnel.
• Collaborate with production, engineering, and quality management teams to address quality issues.
• Ensure compliance with all quality, safety, and workplace regulations.
• Work extended hours, overtime, or weekends as needed.
• Participate in initiatives focused on safety, quality, and cost-saving improvements.
• Communicate team performance updates and provide feedback.
• Maintain goals and deadlines while offering real-time performance feedback.
• Promote Good Manufacturing Practices (GMPs) and cleanroom requirements.
• Additional duties may be assigned as needed.

Must Have:

• Bachelor's degree in a related field.
• 5-7 years of experience in quality assurance or quality control in a manufacturing environment.
• Strong analytical and critical thinking skills.
• Proficiency in quality management software and tools.
• Ability to read and interpret engineering drawings, schematics, and specifications.
• Understanding of manufacturing processes, quality control methodologies, and statistical analysis techniques.
• Knowledge of ISO 13485 and 21 CFR Part 820 quality systems.
• Effective communication skills to convey quality concerns across all levels.
• Strong mathematical skills for data analysis and reporting.
• Proficiency in Microsoft Office (Excel, Outlook, Word, PowerPoint).

Good to Have:

• Six Sigma Green or Black Belt certification.
• Experience leading quality improvement projects.
• Knowledge of validation and first article inspection processes.
• Understanding of GD&T, FMEA, DOE, and GR&R activities.
• Experience using statistical software such as SQC Pack or Minitab.
• Prior experience working with cleanroom requirements and GMPs.

Cirtec Medical Corporation considers everyone 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 its related companies fully endorse equal opportunity. 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 an enjoyable 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 stage of your career and life. 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.