Quality Engineer, Medical Device

Other jobs >> General

Negotiable

Permanent

×

Warning

The form #11 does not exist or it is not published.

Description

SUMMARY OF POSITION

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.



SHIFT

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



WHAT YOU WILL DO

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.



WHAT WE ARE LOOKING FOR



WORK EXPERIENCE

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)



EDUCATION

Bachelor - Engineering Required, , ,



CERTIFICATIONS

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



KNOWLEDGE & SKILLS THAT ENABLE SUCCESS

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)



WHAT WE OFFER

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



PHYSICAL REQUIREMENTS



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



ADDITIONAL REQUIREMENTS

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

How to Apply: Please click here to create a free Pure-jobs.com account and post your resume. Only logged in job seekers can apply for a job.

Find us at:

Never provide bank account, credit card details or any other financial information, or make any form of payment, when applying for a job. If you are ever asked to do this by a recruiter on Pure Jobs please click the Report button or contact us with the advertiser's company name and the title of the job vacancy. You should not send any money to anyone. A genuine employer with a job offer would never ask you to do this.

Report this job
x

Report a job

If you're concerned about a job advert, let us know and our quality team will investigate.

Your name(*)
Invalid Input

Your email address(*)
Invalid Input

Please select you reason(*)

Additional information(*)
Invalid Input

Invalid Input

Get new jobs for this search by email.

Also get an email with jobs recommended just for me.

Create Alert



Subscribe to updates from our blog