Quality Coordinator

Orchid Orthopedic Solutions•Farmington Hills, MI

8d•Onsite

About The Position

The Farmington Hills, MI site was established in 2005. Our 50,000 square foot facility employs approximately 150 team members. Our site focuses primarily on plasma spray coating (HA, TPS) in the spine and large joint for orthopedic implants that enable a longer, active life. A career with Orchid provides growth opportunities, a great benefits package including performance bonuses, medical benefits, 401(k) with company match, and paid time off. For more information, please visit www.orchid-ortho.com.

Requirements

High School Or Equivalent (Required)
Experience in Quality-Related Work (Required)
Accuracy and Attention to Detail - Working Experience
Data Analysis Tools - Working Experience
ISO 9001 (Quality Management) - Basic Knowledge
Organization - Basic Knowledge
Computer Knowledge - Working Experience
Must be able to remain in a stationary position - Frequently
Must be able to move about the inside of the building - Occasionally
Must be able to distinguish and detect information such as writing and defects - Constantly
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

3+ Years of experience with quality systems in a highly regulated industry (i.e. Medical Devices, Aerospace, Pharmaceutical, Food, or Nuclear) (Preferred)

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