Quality Coordinator

Combining Strengths. Expanding Possibilities. Tecomet and Orchid are now one company. Explore more at  USThe 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.

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- Shift 1 ($0) (United States of America
- Michigan)
A BRIEF OVERVIEW 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.

WHAT YOU WILL DOLead 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’sAssist 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 EDUCATION QUALIFICATIONS High School Or Equivalent (Required)
EXPERIENCE QUALIFICATIONS Experience in Quality-Related Work (Required)3+ Years of experience with quality systems in a highly regulated industry (i.e. Medical Devices, Aerospace, Pharmaceutical, Food, or Nuclear) (Preferred)
KNOWLEDGE & SKILLS THAT ENABLE SUCCESS 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 PHYSICAL DEMANDS 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 WHAT WE OFFER Opportunity to work in a growing company

Ability to…