System Quality Assurance Engineer

Confidential Company  •  Morrisville, NC

Less than 5 years experience  •  IT Consulting/Services

Salary depends on experience
Posted on 12/05/17 by Cynet EngineeringTeam
Confidential Company
Morrisville, NC
Less than 5 years experience
IT Consulting/Services
Salary depends on experience
Posted on 12/05/17 Cynet EngineeringTeam

We are looking for ??System Quality Assurance Engineer for our client in Morrisville, NC

Job Title: ??System Quality Assurance Engineer

Job Location: Morrisville, NC

Job Type: Contract – 12 Months / Contract to Hire / Direct Hire

Job Description:

  • Actively contribute to Change Review Board as part of change control process.
  • Ensure compliance to regulatory requirements. 
  • Uphold quality system. 
  • Supportinternal and external audits.
  • Work in a cross-functional team environment including members from Manufacturing, Clinical, Regulatory, and Marketing.
  • Serve as quality representative for New Product Development. 
  • Contribute to requirements definitions and ensure that reliability, quality, and safety requirements are met. 
  • Work closely with Engineering to develop test protocols and reports
  • Develop, implement, and monitor various quality metrics. 
  • Identify opportunities for continuous improvement and customer satisfaction.
  • Compile and represent data for monthly CAPA Review and Product Review meetings, as well as annual reports.
  • Gather and analyze data for root cause analysis. 
  • Coordinate and drive efforts to assure CAPAs are opened and completed appropriately. 
  • Work withEngineering and Manufacturing to develop and implement corrective actions.
  • Support complaint sample evaluations and investigations. 
  • Track complaint data to identify actionable trends. 
  • Respond to customer and regulatory inquiries. 
  • Perform risk assessments and analysis. 
  • Participate in risk management meetings.

Educational qualification (if must):

  • B.S degree in Science or Engineering (CQE certification is preferable)

Mandatory Skills:

  • 3 + years experience in of Medical Device (21 CFR 820) and/or Drug (21 CFR 210 & 211) related industry; quality engineering or product development experiencepreferred; experience with Post Market Surveillance a plus.
  • Understanding and working experience with EN ISO14971, cGMP, QSR, ISO13485, FDA Design Control, document controls, design verification and validation, hazard analysis techniques, and regulatory approval methods
  • Knowledge of quality control process and statistical techniques.
  • Strong analytical and problem solving skills; strong attention to detail.
  • Understanding of manufacturing processes and techniques.
  • Working knowledge of lean manufacturing, Six Sigma, Project Management principles a plus.
  • Proficient with Excel (PivotTables, trending, charting).
  • Excellent verbal and written communication skills, including the ability to influence others.
  • Strong interpersonal skills and the ability to work with cross-functional teams.

Desired Skills:

  • Project management skills
  • High level of initiative with ability to self-manage

Not the right job?
Join Ladders to find it.
With a free Ladders account, you can find the best jobs for you and be found by over 20,0000 recruiters.