Senior Quality Coordinator

Orchid • Lansing, MI

1d

About The Position

Orchid Orthopedic Solutions provides solutions for orthopedic implant procedures enabling a longer, active life. Working in an industry that has the ability to impact lives in such a profound way has proved to be a strong motivator for Orchid. The Lansing facility specializes in the forging and machining of hip and knee implants across our 3 campus. A career with Orchid provides growth opportunities, a great benefits package including performance bonuses, insurance, 401(k) with company match and paid time off. For more information, please visit www.orchid-ortho.com

The Senior Quality Coordinator maintains quality systems, ensures training is performed and recorded as required, and serves as a resource to the Quality and Regulatory functional groups.

Requirements

• High School Or Equivalent (Required)
• 2+ Years of Experience in Quality (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 communicate and exchange information with others - Constantly
• Must be able to distinguish and detect information such as writing and defects - Constantly

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)
• ASQ, CQT, CQA, CQIA, or CQE (Preferred)

Responsibilities

• Processes and reviews document creation/change requests
• Assists document owners with writing, editing and training of new and revised procedures
• Assists with coordinating, tracking, and recording training
• Tracks and trends quality metrics
• Participates in internal and/or external Inspections, as required
• Verifies employee training is current and complete
• Assists with Document Control activities (including, but not limited to: closing jobs in Enterprise Resource Planning (ERP) system, scanning documentation, Device History Record (DHR) reviews)
• Leads CAPAs and audit finding corrections related to the QMS
• Supports the complaint handling unit with containment, quality alert generation and training, and investigation
• Applies methodical problem solving methods to assist with scrap and rework reduction or other continuous improvement activities
• Support implementation and maintenance of QMS-related software
• Collects and analyzes product and process data
• Identifies opportunities and implements solutions for QMS and business process improvements
• Back up the Quality Documentation Coordinator on regulatory release activities pre per FDA QMSR and ISO 13485 when required
• Support quality and compliance by adhering to all procedures, work instructions, and forms per the QMS

Benefits

• Opportunity to work in a growing company
• Ability to help people live a longer, more active life
• Comprehensive benefit package
• Ability to work in an organization that values: Integrity First: We do the right thing Teamwork: We are one Orchid Results: Our results matter

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: High school or GED