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Orchid Orthopedic Solutions · 1 day ago

Quality Engineer

Bridgeport, MI

Full-time

Onsite

Mid Level

3+ years exp

Orchid Orthopedic Solutions is a contract manufacturer of orthopedic devices focused on enabling a longer, active life. The Quality Engineer II will support the ongoing quality of existing products and assist in new production introductions through various quality management processes and tools.

Asset ManagementManufacturingMedicalPackaging ServicesProduct DesignProject Management

No H1B

Responsibilities

Completes all required training

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. Ensures safety operating practices are demonstrated. Reports issues/concerns to Supervisor

Support quality and compliance by adhering to all procedures, work instructions, and forms per the Quality Management Systems (QMS)

Qualification

Statistical AnalysisQuality Management SystemsProcess ValidationLean ManufacturingQuality CertificationManufacturing SafetyComputer KnowledgeCommunicationProblem SolvingAttention to Detail

Required

Bachelor (Required)

3+ Years of Experience (Required)

Operational Functions - Working Experience

Quality Management - Working Experience

Process Management - Working Experience

Accuracy and Attention to Detail - Working Experience

Manufacturing Safety - Working Experience

Lean Manufacturing - Working Experience

Statistical Analysis and Measurement - Working Experience

Production Part Approval Process (PPAP) - Working Experience

Production Runs - Extensive Experience

Final Inspection - Working Experience

Computer Knowledge - Working Experience

Problem Solving - 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 move equipment around the building - Occasionally

Must be able to position oneself and move under/around/over equipment - Occasionally

Must be able to communicate and exchange information with others - Frequently

Must be able to distinguish and detect information such as writing and defects - Frequently

Noise - Occasionally

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