Quality Coordinator

Orchid•Detroit, MI

3d•Onsite

About The Position

The Quality Coordinator is responsible for a variety of activities to ensure quality and compliance needs are met. S/he is responsible for maintaining quality systems, ensuring training is performed and recorded as required, coordinating documentation maintenance and change control, ensuring monitoring, measuring and test equipment is calibrated as required, process monitoring, supporting continuous improvement initiatives, and compliance adherence.

Requirements

High School Or Equivalent (Required)
Experience in Quality-Related Work (Required)
Accuracy and Attention to Detail - Working Experience
Data Analysis Tools - Working Experience
Organization - Basic Knowledge
Computer Knowledge - Working Experience

Nice To Haves

3+ Years of experience with quality systems in a highly regulated industry (i.e. Medical Devices, Aerospace, Pharmaceutical, Food, or Nuclear) (Preferred)
ISO 9001 (Quality Management) - Basic Knowledge

Responsibilities

Lead Document Control activities, including but not limited to updating controlled documents including Forms, Procedures, Work Instructions, Policies and Documents, final release of Engineering Change Orders, maintenance of document logs
Support training programs and ensure they meet all applicable regulatory and company requirements.
Supporting process monitoring by conducting sample collection for production utilities, including but not limited to, compressed air system, water system, cleanline monitoring, tension testing, abrasion testing
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
Tracks and trends quality metrics
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