Quality Engineering Tech

Orchid•Arab, AL

6d•Onsite

About The Position

The Quality Tech I is responsible for a variety of activities to ensure quality and compliance needs are met. S/he is responsible for manufacturing readiness quality planning, sustaining process quality, continuous improvement initiatives, and compliance adherence.

Requirements

High School Or Equivalent (Required)
5+ Years of Experience in a Manufacturing Environment (Required)
Communication - Basic Knowledge
Computer Knowledge - Working Experience
Decision Making and Critical Thinking - Basic Knowledge
ISO 13485 - Working Experience
GD&T - Working Experience
Flexibility & Adaptability - Basic Knowledge
Manufacturing Industry - Working Experience
Quality Inspection Metrology Tools - Working Experience
Mathematical Ability - Working Experience
Problem Solving - Working Experience
Candidates offered employment may be required to submit to a pre-employment background check and pre-employment drug-screening based on position requirements
Applicants must be authorized to work for ANY employer in the U.S. We are unable to sponsor or take over sponsorship of an employment Visa at this time
Candidates must be able to provide proof of eligibility to work in the United States through eVerify

Nice To Haves

Associates (Preferred)
Experience in Medical Device Manufacturing (Preferred)
Experience in Quality-Related Work (Preferred)
Experience as a Trainer (Preferred)
Experience with FDA and ISO systems relating to medical devices (Preferred)
Training Any (Preferred)

Responsibilities

Update controlled documents including Forms, Procedures, Work Instructions, Policies and Documents.
Support training programs and ensure they meet all applicable regulatory and company requirements.
Inspects parts using precision measuring equipment
Works with the Sustaining Product Quality and NPI group as required on the review and/or implementation of Quality planning such as FAR’s, FIF’s
Assist the quality team on the implementation, training and use of precision measuring equipment
Works with customers when measurement system analysis is required
Performs daily, weekly, and monthly calibration of all measuring equipment other than handheld gages
Advises all team members on compliance requirements and regulations
Assists in internal and/or customer audits
Work with suppliers on quality improvement and process improvement
Assists with establishing procedures, work instructions, etc. that meet FDA guidelines
Read and interpret customer drawings and specifications to develop and maintain Quality Inspection Plan and other documents that are part of the Orchid Quality System.
Participate on cross-functional new and legacy project teams.
Assist engineers with the conceptualization and development of part fixtures to hold parts during inspection.
Work with customer and QC to determine customer dimensional and cosmetic acceptance criteria and inspection methods where they are not clearly defined by the customer