Quality Engineering Technician

About the role

Reporting to Quality Manager, the Quality Engineering Technician plays a crucial role in ensuring the production of high-quality products while maintaining and improving our quality management systems to meet regulatory requirements. The ideal candidate must be able to work independently and as a team, have a strong work ethic, a positive attitude, and strong commitment to quality.

Responsibilities

• Perform root cause investigations of non-conformities; implementing corrective and preventative actions to prevent recurrence.
• Support Corrective and Preventive Actions (CAPA) to continuously improve the quality management system.
• Maintain the computerized maintenance management system by entering new equipment and equipment changes.
• Support the calibration program by ensuring timely completion calibrations.
• Create and implement effective quality controls by establishing monitoring, sampling, and inspection methods.
• Lead and participate in the development and implementation of quality systems, records, and procedures to ensure compliance with applicable regulatory requirements, standards, and company policies.
• Support internal audits to assess the effectiveness of the quality management systems.
• Conduct regular inspections and audits to identify defects, deviations, or non-compliance issues.
• Provide training and support to employees to ensure adherence to quality standards.
• Support external audits from regulatory bodies and customers.
• Identify, champion and support continuous improvement projects in quality, productivity, and/or safety.
• Support quality metrics trending and analysis.
• Perform lot history record review, releasing manufacturing lots and issuing certificates of conformance to customers.
• Serve as a subject matter expert in quality assurance on cross-functional teams ensuring compliance to the compliance with applicable regulatory requirements, standards, and company policies.

Requirements

Minimum two (2) years experience working in a Quality Department in a manufacturing environment. Experience within Medical Device or other regulated industries preferred. Strong analytical and problem-solving skills. Familiarity with quality management systems and tools. Detail-oriented with a focus on root cause analysis. Excellent interpersonal skills, with ability to collaborate with and support all levels of associates. Demonstrated ability to assess priority, complete tasks, and work independently. Demonstrated verbal and written communication skills, organized and effective technical writing. Working knowledge of ISO 13485.

Qualifications

Must be a U.S. citizen, a lawful permanent resident (Green Card holder), or an individual granted refugee or asylum status in the U.S.

Skills

Strong analytical and problem-solving skills. Familiarity with quality management systems and tools. Detail-oriented with a focus on root cause analysis. Excellent interpersonal skills, with ability to collaborate with and support all levels of associates. Demonstrated ability to assess priority, complete tasks, and work independently. Demonstrated verbal and written communication skills, organized and effective technical writing. Working knowledge of ISO 13485.

Benefits

We’re a company that values you and your career path and recognizes the importance of work-life balance. In addition to being part of a locally owned and operated business who values treating everyone with integrity and respect, we offer the following benefits to our employees:

• Employee and/or Employee + Child(ren) medical insurance costs you just $1/month!
• Comprehensive Dental + Vision
• 401k Retirement Plan that we match up to 3%
• Basic Life AD&D Insurance
• Employee Assistance Program
• Paid time off — 18 days first year (pro-rated)
• Paid holidays — 9 days
• Annual Performance Bonus Potential
• Employee Profit Sharing
• Tuition Assistance
• Shift differential: 2nd shift – + $1/hr, 3rd shift – + $3/hr

Pay

Competitive salary based on experience and qualifications.

Schedule

Flexible schedule to support work-life balance.