CAPA Quality Engineer

Lancesoft

Murrysville, PA

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JOB DETAILS

SALARY

$146.90

SKILLS

Board Meeting, Calendar Management, Code of Federal Regulations, Corrective Action, Corrective and Preventative Action (CAPA) Systems, Cross-Functional, Data Analysis, Hardware Design, ISO (International Organization for Standardization), ISO 9001, Identify Issues, Mentoring, Problem Solving Skills, Project/Program Management, Quality Engineering, Quality Monitoring, Regulatory Requirements, Root Cause Analysis, Software Design, Statistics, Team Lead/Manager, Testing, Time Management

LOCATION

Murrysville, PA

POSTED

30+ days ago

Role:              CAPA Quality Engineer
Location:          Murrysville, PA or Cambridge, MA (Hybrid)
Duration:          12+ Months (Possible extension or Conversion)
Pay Rate:          $80-108.00/hrW2
Shift hour:                1st Shift Hybrid

Job Description:

Facilitate product and process Corrective and Preventive Action (CAPA) investigations from issue identification through implementation of solution and effectiveness monitoring.

·Project manage all aspects of CAPA activity which includes gaining the commitment of cross functional resources, scheduling CAPA team meetings, and ensuring CAPA deliverables per project timelines.
·Represent CAPAs during audits and CAPA Review Board meetings.
·Lead and mentor cross functional teams with the implementation of appropriate root cause analysis techniques (e.G. Pride problem solving).
·Analyze quality monitoring data sources and apply statistical techniques to identify existing and potential causes of non-conformances.
·Work effectively with all levels of management to ensure CAPA action plans can be supported and that costs/resources needed to implement the plan are available.
•Independently produces and completes CAPA (Corrective and Preventive Action) records.
•Responsible for performing timely, detailed CAPA engineering tasks like assessing issue descriptions, reviewing CAPA data sources, assisting with root cause analysis, and quality problem-solving.

Able to understand and analyze complex problems, including software and hardware design issues.
Demonstrated knowledge of tools and techniques required to perform thorough root cause analysis and develop strong investigations.
Strong understanding of appropriate global regulations, requirements, and standards such as 21 CFR Parts 803, 806, and 820, ISO 13485, ISO 9001 and ISO 14971.
Demonstrated ability to partner with the business and effectively interact with and influence employees, and managers on all levels.
Strong Project Management skills, including ability to project manage all CAPA activities. Ability to analyze data and apply statistical techniques.

Responsible for leading CAPA engineering activities like: assessing complex investigations and corrective actions and reviewing test and other complex performance data, leading complex root cause analysis and complex quality problem solving.
Bachelor’s engineering degree with >5 years of related experience, or a Master’s degree with >3 years of related experience.

About the Company

Lancesoft

We are a $125 Million, NMSDC-certified Minority & Woman owned Workforce Solutions Company headquartered in the DC metro area with presence across US with global presence - Canada, Mexico, India, UK, Malaysia, Indonasia, Hongkong, Singapore, UAE. We are specialized in providing Workforce Solutions, SOW project delivery, Engineering Solutions, Creative Services. We currently support 100+ Fortune companies globally and across multiple industry segments. We are currently supporting several massive programs across industry segment nationally/globally (Intel, Ally, AMD, QUALCOMM, Morgan Stanley, Kraft/ Mondelez, MNP, Amdocs, Dell, SanDisk, Medtronic, Becton Dickinson, GE, Lockheed Martin, UTC, L-3 Communications, Caterpillar, BMW, Mercedes Benz, National Grid, Dominion, Energy Future Holdings, PSEG, 3M, Fidelity, Aetna, Humana, Johnson & Johnson, Pfizer, Merck etc).

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender, identity, national origin, disability, or protected veteran status.

COMPANY SIZE

2,000 to 2,499 employees

INDUSTRY

Staffing/Employment Agencies

FOUNDED

2000

WEBSITE

http://www.lancesoft.com/