Quality Engineer I

About the Role

The Quality Engineer is primarily responsible for monitoring and auditing the quality of all manufactured goods in our medical device industry. This role will have a specific area/customer of responsibility and assist with various tasks and responsibilities assigned by the Quality Manager. The Quality Engineer will support the Quality department by analyzing and pinpointing root causes and corrective actions (CAPAs).

Responsibilities

• Conduct root cause analysis and implementation of corrective action for process/product-related concerns.
• Responsible for continual improvement activities to enhance the quality system using cross-functional teams.
• Interface with Engineering and Operations to ensure transfer to Production of new products are in accordance with approved data.
• Interact with Customers, Sales, and Engineering on new product introduction (NPI) activities for new programs.
• Work with Engineering to coordinate and prepare sample submission packages; update and maintain FAI, FMEAs, Process Flow diagrams, and Process Control Plans.
• Work with Engineering and Operations to solve in-house quality concerns, review nonconforming products, and recommend disposition.
• Conduct investigations on non-conformance and recommend corrective action to prevent reoccurrence.
• Support Quality Inspectors to ensure products and processes comply with relevant requirements of the quality management system.
• Conduct audits, including closing out audit findings, creating audit findings reports, and determining proper corrective and preventive actions within regulated medical device-based quality systems (e.g., ISO 13485, CFR Part 820).
• Analyze failures and implement corrective and preventive actions to respond to customer complaints.
• Create and maintain company quality documentation, such as quality procedures and work instructions.
• Prepare various quality reports.

Requirements

• Bachelor's Degree in a technical/engineering field (STEM).
• 0-2+ years of experience in Quality Assurance in a manufacturing environment (rubber components and/or medical manufacturing highly preferred).
• Knowledge of GD&T, FMEA, DOE, GR&R activities.
• Ability to read and interpret engineering drawings, schematics, and specifications.
• Familiarity with ISO 13485 quality systems.
• Excellent verbal and written communication skills to interact at all levels within the organization, as well as with customers and suppliers.
• Ability to provide concise direction in spoken or written formats.
• Strong working knowledge of Statistical Process Control methods using intermediate and advanced statistics.
• Intermediate MS Office skills; ability to create charts and reports to support quality activities.

Qualifications

• Basic MiniTab knowledge desired.
• CQE or CQA certification preferred.
• Six Sigma Green Belt certification preferred.

Benefits

• Training and career development.
• Healthcare and well-being programs, including medical, dental, vision, wellness, and occupational health programs.
• Paid Time Off.
• 401(k) retirement savings with a company match.

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.