Quality Engineering Tech — Medical Devices & Compliance

Orchid MPS Holdings, LLC; Arab, Northern (AL, KY); Hybrid; USD 52,000 - 78,000; Full time

Benefits offered by this job

Comprehensive benefit package

Opportunity to work in a growing公司

Integrity First: We do the right thing

Job summary

Orchid MPS Holdings, LLC is seeking a Quality Tech I to support manufacturing readiness, sustain process quality, and drive continuous improvement. You will update documents, train staff, and ensure compliance with FDA and ISO guidelines while inspecting parts with precision measuring equipment.

You will collaborate with cross-functional teams, perform calibration tasks, and assist in audits and supplier quality initiatives to maintain Orchid's Quality System and drawings-based inspection plans.

Qualifications

• High School or equivalent required; Associate degree preferred.
• Experience in Medical Device Manufacturing is preferred.
• Experience in Quality-Related Work and as a Trainer is preferred.
• Experience with FDA and ISO systems relating to medical devices is preferred.
• 5+ years in a manufacturing environment is required.
• Training experience preferred.

Responsibilities

• Update controlled documents including Forms, Procedures, Work Instructions, Policies and Documents.
• Support training programs and ensure regulatory and company requirements are met.
• Inspect parts using precision measuring equipment.
• Review and implement Quality planning with Sustaining Product Quality and NPI groups.
• Assist with calibration of measuring equipment and participate in audits.
• Collaborate with customers on measurement system analyses as needed.
• Work with suppliers on quality and process improvement.
• Develop procedures and work instructions meeting FDA guidelines.
• Read and interpret customer drawings to maintain the Quality Inspection Plan.

Skills

Communication skills

GD&T

Quality inspection metrology tools

Problem solving

Math skills

Analytical thinking

Reading drawings

Education

High School Diploma or equivalent

Associate degree (Preferred)

Tools

Precision measuring equipment

Job description

Orchid MPS Holdings, LLC is seeking a Quality Tech I to support manufacturing readiness, sustain process quality, and drive continuous improvement. You will update documents, train staff, and ensure compliance with FDA and ISO guidelines while inspecting parts with precision measuring equipment.

You will collaborate with cross-functional teams, perform calibration tasks, and assist in audits and supplier quality initiatives to maintain Orchid's Quality System and drawings-based inspection plans.