Morrisville, North carolina
Quality Assurance Engineer Job Opening in Morrisville, North carolina - About HCL
As an IT services provider, HCL provides custom software development, product engineering and consulting services to Fortune 1000 companies in a variety of industries. HCL is a $6.7 billion IT services company with over 111,092 professionals operating across 31 countries and is growing at 14% YOY in revenues. There are around 10,000 employees in the U.S under the HCL America Inc. branch of HCL.
Job Description :
Job Title: System Quality Assurance Engineer
Location: North Carolina, 27560, USA.
Actively contribute to Change Review Board as part of change control process,
Ensure compliance to regulatory requirements. Uphold quality system. Support internal 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 analyse data for root cause analysis. Coordinate and drive efforts to assure CAPAs are opened and completed appropriately. Work with Engineering 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.
Mandatory Skills
Technical / Soft Skills
Expertise Level (Expert / Good / Knowledge)
3 + years experience in of Medical Device (21 CFR 820) and/or Drug (21 CFR 210 & 211) related industry; quality engineering or product development experience preferred; 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
Technical / Soft Skills
Expertise Level (Expert / Good / Knowledge)
Project management skills
High level of initiative with ability to self-manage
Job Type: Full-time
Required experience:
Quality Assurance: 5 years
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