Quality Engineer, Medical Device

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The Quality Engineer, Sustaining Product Quality supports the ongoing quality of Orchids products. Responsible for providing advanced quality planning and ongoing engineering support. Effectively disseminate customer requirements and generate controls to meet those requirements. Works with engineers, supervisors, managers, production personnel, suppliers and customers to help resolve quality issues, achieve team objectives, and promote quality principles.


No Shift ($0) (United States of America)


Designated member of the complaint handling unit. Performs responsibilities of a Complaint Handling Unit designee including containment, root cause analysis, corrective action, review and reporting for customer returns and complaints.

Supports continuous improvement as a change agent for internal rework and scrap reduction and process optimization.

Liaise with suppliers and customers to establish acceptance criteria, inspection methods, address concerns, and resolve issues.

Assists in the development of essential QMS deliverables including, but not limited to: complaint analysis, risk analysis, failure mode and effects analysis, CAPA, and process/equipment/software verification/validation.

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.

Work with Engineering to document or revise current processes and parameters and develop written instructions to eliminate unnecessary process variation.

Performs quality reviews and internal audits; evaluates data and writes reports to validate or indicate deviations from existing standards.

Perform necessary training related to CAPAs and continuous improvement efforts.

Mentors quality and production personnel on problem solving and proper inspection techniques.

Works with cross-functional teams to solve production and quality problems.

Use handheld inspection tools for measurement purposes, such as micrometers, calipers, height gages, optical comparator, gage blocks/pins, and dial indicators.

Perform visual and/or cosmetic inspection of product following applicable procedure(s) using appropriate light sources. Monitor equipment to ensure proper operation and escalate any equipment-related issues.

Support the Quality Management System (QMS) by utilizing One Orchid global processes, complying with applicable documentation requirements and establishing/supporting plan(s) to meet/exceed Key Performance Indicators (KPIs) for Quality that support Safety, Compliance, Six Sigma Quality, On-Time Delivery (OTD) and financial objectives.

Back up the Quality Documentation Coordinator on Regulatory Release activities per FDA 21 CFR 820.80 (d) when required.



1+ Years of Experience in an FDA-Regulated manufacturing Environment, 2+ Years of Engineering or Quality Experience (Required), 2+ Years of Experience in Visual Inspection, Manufacturing Experience (Required)


Bachelor - Engineering Required, , ,


Certified Quality Engineer (CQE) - American Society for Quality (ASQ)


Accuracy and Attention to Detail (Working Experience), Communication (Basic Knowledge), Computer Knowledge (Working Experience), Final Inspection (Basic Knowledge), Lean Manufacturing (Working Experience), Manufacturing Safety (Working Experience), Operational Functions (Working Experience), Problem Solving (Working Experience), Process Management (Working Experience), Production Part Approval Process (PPAP) (Basic Knowledge), Production Runs (Working Experience), Quality Management (Working Experience), Statistical Analysis and Measurement (Basic Knowledge)


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


Corrected 20/20 vision

Constantly operates a computer

Must be able to remain in a sitting position 50% of the time

Must be able to remain in a standing position 50% of the time

Occasionally visually inspect parts

Occasionally lifts and/or moves up to 50 pounds

Ability to work mandatory overtime and weekends as required

Frequently grasps objects


Candidates offered employment may be required to submit to a pre-employment background check and pre-employment drug-screening based on position requirements

Candidates must be able to provide proof of eligibility to work in the United States through eVerify

EOE, including disability/vets
  • 1
  • Negotiable
  • None
  • None
  • Re-341743
  • Permanent
  • 16

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