Overview
Quality Manager Jobs in Zeeland, MI at Aurorium LLC
Introduction
We are looking for an experienced Quality Engineer to join our team!
About the Company
Intech is a global market leader and game-changer in the manufacturing of orthopedic medical devices. It all starts with innovation, and nobody knows this better than Intech. With manufacturing facilities around the world and unique initiatives and savoir-faire, Intech is at the forefront of technological innovation in the field of orthopedic device manufacturing as well as asset management, ensuring that optimal patient care is delivered day in, day out. This is who we are. We tech care.
Here at Turner Medical Inc. dba Intech we give our customers a competitive edge in today’s highly specialized design and development of OEM orthopedic and spinal instrumentation. We manufacture world-class instruments to meet our customers’ most demanding requirements.
$500 Employee Deductible Medical Plan – 100% employer paid!
About the Quality Engineer Role
Working as a Quality Engineer at Intech will give you the opportunity to gain experience in the quality process of creating complex spinal and orthopedic instruments that improve the lives of patients around the world! You will use sound and proven engineering principles, best practices, and concepts to assist in the developing processes and process requirements from internal and external stakeholders.
Essential Duties and Responsibilities:
Uses quality tools to implement improvements including process flowcharting, Pareto analysis, correlation and regression analysis, significance tests, design of experiments, statistical process control, gauge repeatability and reproducibility, and trend analysis techniques.
Acts as a customer liaison and processes customer quality complaints, as applicable.
Collects, Analyzes, and Presents data using statistical methodology.
Assists suppliers with the interpretation of quality requirements, as applicable.
Assists the development of essential QMS deliverables/Advanced Product Quality Planning (APQP) including, but not limited to complaint analysis, risk analysis, failure mode and effects analysis, CAPA, and process/equipment/software verification / validation.
Plans and/or conducts process and equipment validations and special validations including installation qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
Interfaces with appropriate customer contacts to clarify customer requirements.
Determines machine and/or process capability through planning and/or executing Process Capability studies.
Develops inspection criteria that connect customer requirements and manufacturing processes that include identification of key characteristics, associated sampling plans, and required gauging.
Conceives and/or Leads productivity improvements and/or Continuous improvement projects.
Monitors engineering production processes and products for adherence to internal and external requirements and practices.
Participates in pre- and post-production launch reviews providing quality engineering support.
Performs quality reviews and internal audits; evaluates data and writes associated reports.
Recommends modifications to existing quality or production standards, where applicable, to achieve optimum quality within limits of equipment capability.
Reviews and approves product/process and document change requests.
Reviews drawings to evaluate quality requirements including correct application of geometric dimensioning and tolerance, proper use of process and material specifications, and key characteristics for inspection plans and gauging techniques.
Supports measuring and analyzing key metrics to monitor performance.
Works with cross-functional teams to solve production and quality problems.
Reinforces safety expectations. Reports issues or concerns to Supervisor.
Support quality and compliance by adhering to all procedures, work instructions, and forms per the Quality Management Systems (QMS).
Job Qualifications
3-5 years of experience in Quality Engineer role in ISO/FDA machine shop, contract manufacturer.
Bachelor’s degree in engineering or related technical field; or equivalent combination of related experience and/or training.
Understanding how to read and interpret Geometric Dimensioning and Tolerancing (GD&T) callouts on part prints to effectively run quality parts.
Knowledge of precision measuring instruments and the application of such instruments. Instruments should include but not limited to calipers, micrometers, depth gages, indicators, and scales.
Must be adaptable to a changing environment, competing demands and is able to deal well with frequent change, delays, or unexpected events.
Critical thinking, advanced decision-making skills and mechanical aptitude.
Ability to identify varied materials and their relationship to design (form, fit, and function).
Ability to read, comprehend, follow, and document work instructions, blueprints, routers, and standard operating procedures.
Ability to collaborate and assist team members, provide input to the area lead, and attend/participate effectively in meetings.
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Title: Quality Manager
Company: Aurorium LLC
Location: Zeeland, MI
