Quality Analyst

Overview
SpiTrex MDI is seeking a highly skilled Quality Analyst with expertise in precision inspection of medical devices. This role requires advanced knowledge of GD&T, experience operating CMMs using MCOSMOS software, and the ability to perform complex inspections with minimal supervision. The ideal candidate will play a key role in ensuring compliance with strict medical industry quality standards.

Responsibilities

• Perform detailed inspections of intricate medical components using precision measuring equipment such as micrometers, calipers, thread plug and ring go/no-go.
• Operate and program CMMs using MCOSMOS software for first piece, in-process, and final inspections.
• Interpret complex part drawings and GD&T requirements to verify dimensional accuracy and ensure compliance with specifications.
• Perform first article inspections (FAI) and support process validation for new and existing products.
• Accurately document inspection findings, prepare reports, and maintain quality records.
• Work closely with machinists and engineers to resolve quality concerns and improve processes.
• Assist in developing inspection documentation and best practices for quality assurance.
• Maintain compliance with ISO 13485 and other relevant medical device quality standards.
• Ensure a safe and organized work environment by following company and regulatory procedures.

Requirements

• Proven experience in quality control or assurance within a manufacturing environment.
• MUST know how to program and operate various CMMs and Software.
• Strong knowledge of quality systems, including ISO 13485 and FDA regulations.
• Familiarity with Minitab software for measurement analysis is preferred.
• Experience conducting internal and customer required quality audits.
• Proficiency in using measurement tools such as calipers, gauges, and other inspection equipment.
• Excellent attention to detail with strong analytical skills.
• Ability to work collaboratively within a team environment while maintaining independence in decision-making.
• Strong communication skills, both written and verbal.
• A commitment to continuous improvement and professional development in the field of quality control.

Join us as we strive for excellence in our products while ensuring compliance with industry standards. Your expertise will help us maintain our reputation for delivering high-quality solutions.

Job Types: Full-time, Permanent

Pay: $27.00 - $35.00 per hour

Expected hours: 40 per week

Benefits:

• 401(k)
• Dental insurance
• Health insurance
• Health savings account
• Paid time off
• Vision insurance

Schedule:

• Day shift
• Monday to Friday

Shift availability:

• Day Shift (Required)

Ability to Commute:

• Lancaster, PA 17601 (Required)

Ability to Relocate:

• Lancaster, PA 17601: Relocate before starting work (Required)

Work Location: In person

Salary : $27 - $35