Quality Engineer

Company : LanceSoft Inc

Shift: Monday-Friday, 1st shift hours
Duration: 06 Months
Pay range: $56.50 Hourly – $56.50 Hourly 
Onsite
How Will You Make an Impact?

As a Quality Engineer, you will independently lead complex quality investigations and drive resolution of nonconformances, CAPAs, and customer complaints. You will act as a key contributor to ensuring product quality, regulatory compliance, and customer satisfaction by applying strong technical judgment, structured problem-solving, and cross-functional collaboration. You will also help strengthen quality processes through data analysis and continuous improvement initiatives.

What Will You Do?

Corrective and Preventive Actions

• Own end-to-end CAPA activities for assigned issues, including initiation, investigation, root cause analysis, action definition, and effectiveness verification.
• Apply structured root cause analysis methodologies (8D, 5 Whys, Fishbone, data analysis) to ensure robust problem-solving.
• Develop practical, risk-based corrective and preventive actions that address systemic issues.
• Ensure CAPAs are timely, compliant, and effective, with clear documentation and traceability.
• Identify gaps in CAPA quality or delays and proactively escalate risks to management.

Customer Complaint Investigations

• Lead customer complaint investigations of moderate to high complexity, including coordination with manufacturing, engineering, service, and supplier teams.
• Conduct failure analysis and root cause determination using available data, returned product evaluation, and technical expertise.
• Ensure complaints are handled in accordance with regulatory and internal requirements, including proper documentation and closure timelines.
• Link complaint findings to internal nonconformances and CAPAs to ensure closed-loop quality.
• Analyze complaint trends and support identification of systemic product or process issues.

Cross-Functional Quality Leadership

• Act as a quality lead on investigation teams, driving accountability and timely resolution across functions.
• Support product containment decisions, including risk assessments, product holds, and impact evaluations.
• Collaborate with supplier quality to address supplier-related nonconformances and SCARs.
• Provide technical input during audits, inspections, and quality reviews.
• Support development and improvement of procedures, work instructions, and quality system processes.

Data Analysis & Continuous Improvement

• Perform data-driven analysis across NCM, CAPA, and complaints to identify trends and improvement opportunities.
• Lead or contribute to continuous improvement initiatives using Lean, PPI, or Six Sigma methodologies.
• Recommend and help implement improvements to investigation quality, cycle time, and process effectiveness.
• Support development of quality metrics and dashboards for monitoring performance.

Capability Building

• Provide guidance and informal mentorship to team members on RCA and investigation best practices.
• Promote consistent use of structured problem-solving tools and quality principles across teams.

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How Will You Get Here?
Education
• Bachelor’s degree in Engineering or related technical discipline required.
Experience
• 5–8 years of quality engineering experience, preferably in regulated industries (cGMP, ISO 9001/13485).
• Demonstrated experience leading nonconformance investigations, CAPAs, and customer complaint handling.
• Experience working cross-functionally with Manufacturing, R&D, and Supplier Quality.
• Familiarity with failure analysis, and risk-based decision making.
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Knowledge, Skills & Abilities
• Strong knowledge of quality systems, regulatory requirements, and investigation processes
• Proficient in root cause analysis and structured problem-solving methodologies
• Ability to independently manage multiple complex investigations
• Strong analytical and data-driven decision-making skills
• Effective communication and ability to influence cross-functional teams
• Detail-oriented with strong technical documentation skills
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Physical Requirements
• Ability to work onsite in both office and manufacturing environments.
• Ability to lift up to 35 lbs occasionally.
• Ability to work at a computer for extended periods (up to 8 hours/day).

Employee Benefits:
At LanceSoft, full time regular employees who work a minimum of 30 hours a week or more are entitled to the following benefits:

• Four options of medical Insurance
• Dental and Vision Insurance
• 401k Contributions
• Critical Illness Insurance
• Voluntary Permanent Life Insurance
• Accident Insurance
• Other Employee Perks

About LanceSoft
LanceSoft is rated as one of the largest staffing firms in the US by SIA. Our mission is to establish global cross-culture human connections that further the careers of our employees and strengthen the businesses of our clients. We are driven to use the power of our global network to connect businesses with the right people, and people with the right businesses without bias. We provide Global Workforce Solutions with a human touch. 

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