Quality Engineer- 6-month Contract
CooperSurgical
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- Location
- Henrietta, NY
- Work style
- On-site
- Job type
- Full time
- Posted
- Oct 7
- 13 days ago
Career path
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About the company
CooperSurgical
Medical devices · 1,001 to 5,000 employees
What you'll do
- Support Quality Engineering functions in Packaging and Distribution, including leading root cause investigations of NCRs, CAPAs, and customer complaints, engineering change orders, validation, and risk management.
What you need
- <p style="margin-bottom:0in;margin-right:0in;margin-top:0in;punctuation-wrap:simple;tab-stops:list 9.0pt;text-autospace:none;vertical-align:baseline;">Demonstrated project management and problem-solving skills. </p>
- <p style="margin-bottom:0in;margin-right:0in;margin-top:0in;punctuation-wrap:simple;tab-stops:list 9.0pt;text-autospace:none;vertical-align:baseline;">Demonstrated communication, facilitation and leadership skills, with the ability to work cross-functionally in a team environment. Applied technical knowledge of Qualitative and Quantitative data analysis, and statistical tools including DOEs. Six Sigma GB/BB or CQE preferred.</p>
- <p style="margin-bottom:0in;margin-right:0in;margin-top:0in;punctuation-wrap:simple;tab-stops:list 9.0pt;text-autospace:none;vertical-align:baseline;">Must possess the ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or government regulations. Able to write reports, business correspondence, and procedure manuals. Possess the ability to effectively present information and respond to questions from groups of senior managers.</p>
- <p style="margin-bottom:0in;margin-right:0in;margin-top:0in;punctuation-wrap:simple;tab-stops:list 9.0pt;text-autospace:none;vertical-align:baseline;">Has a working knowledge of Quality System Regulation (21 CFR PART 820, including 21CFR806) and ISO 13485 requirements.</p>
- <p style="margin-bottom:0in;margin-right:0in;margin-top:0in;punctuation-wrap:simple;tab-stops:list 9.0pt;text-autospace:none;vertical-align:baseline;">Microsoft Windows, Microsoft Excel, Minitab.</p>
- <p style="margin-bottom:0in;margin-right:0in;margin-top:0in;punctuation-wrap:simple;tab-stops:list 9.0pt;text-autospace:none;vertical-align:baseline;">BAAN, Agile, JDA familiarity a plus.</p>
- <p style="margin-bottom:0in;margin-right:0in;margin-top:0in;punctuation-wrap:simple;tab-stops:list 9.0pt;text-autospace:none;vertical-align:baseline;">Normal Office environment.</p>
- <p style="margin-bottom:0in;margin-right:0in;margin-top:0in;punctuation-wrap:simple;tab-stops:list 9.0pt;text-autospace:none;vertical-align:baseline;">Ability to perform light to medium physical work and standing for long periods of time, if required depending on the task.</p>
- <p style="margin-bottom:0in;margin-right:0in;margin-top:0in;punctuation-wrap:simple;tab-stops:list 9.0pt;text-autospace:none;vertical-align:baseline;">Minimum of 3 plus years applicable experience and/or training or equivalent combination of education and experience with medical device distribution and packaging operations.</p>
- <p style="margin-bottom:0in;margin-right:0in;margin-top:0in;punctuation-wrap:simple;tab-stops:list 9.0pt;text-autospace:none;vertical-align:baseline;">Bachelor’s degree (B.S.) from four –year college or university in engineering or related discipline; equivalent combination of education and experience may be considered.</p>
- <p style="margin-bottom:0in;margin-right:0in;margin-top:0in;punctuation-wrap:simple;tab-stops:list 9.0pt;text-autospace:none;vertical-align:baseline;">Certified Quality Engineer, Green Belt or Lean certified preferred.</p>
Key skills
root cause investigationNCRsCAPAscustomer complaintsengineering change ordersvalidationrisk management
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Read the full posting here
Support key functions at the CooperVision Henrietta Facility within the Quality Engineering team in Packaging and Distribution. Quality Engineering scope includes supporting and leading root cause investigation of NCRs, CAPAs, and customer complaints, engineering change orders, validation and risk management.