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Quality Senior Engineer I

TekWissen LLC

Englewood, CO

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JOB DETAILS
SALARY
$48–$52
SKILLS
Analysis Skills, Certified Quality Engineer (CQE), Code of Federal Regulations, Communication Skills, Control Systems, Corrective and Preventative Action (CAPA) Systems, Cross-Functional, Detail Oriented, Document Control, Documentation Review, Documentation Standards, FDA (Food and Drug Administration), Failure Mode and Effects Analysis (FMEA), ISO (International Organization for Standardization), Medical Equipment, Microsoft Excel, Microsoft Office, Microsoft PowerPoint, Microsoft Word, Multitasking, Organizational Skills, Orthopedics, Problem Solving Skills, Quality Engineering, Quality Management, Quality System Requirements (QSR), Regulations, Risk, Risk Management, Root Cause Analysis, Statistics, Support Documentation, Technical Writing, Workforce Management, Writing Skills
LOCATION
Englewood, CO
POSTED
5 days ago
Overview:
TekWissen Group is a workforce management provider throughout the USA and many other countries in the world. Client is a publicly traded medical device company. Client designs, develops, manufactures and markets orthopedics products, including knee, hip, shoulder, elbow, foot and ankle artificial joints and dental prostheses. client has operations in more than 40 countries around the world

Job Title: Quality Senior Engineer I
Work Location: Englewood, CO 80112
Duration: 11 Months
Job Type: Temporary Assignment
Work Type: Onsite

Job Description
  • Review, remediate, and migrate legacy CAPA records into EtQ to ensure completeness, accuracy, and compliance with global procedures.
  • Manage assigned CAPAs through initiation, investigation support, action tracking, effectiveness verification, and closure.
  • Perform gap assessments of CAPA records and support correction of documentation deficiencies to meet regulatory and internal quality system requirements.
  • Partner cross-functionally with Quality, Regulatory, Operations, and Engineering to support CAPA execution and remediation activities.
  • Support compliance to global CAPA procedures, including documentation standards, timeliness expectations, and record retention requirements.
  • Assist with training and user guidance related to CAPA procedures and EtQ processes.
Skills
  • Working knowledge of CAPA processes, root cause analysis, and quality system requirements.
  • Experience with electronic Quality Management Systems (EtQ preferred).
  • Knowledge of applicable regulations and standards, including 21 CFR Part 820, ISO 13485, and risk-based quality principles.
  • Strong technical writing and documentation review skills.
  • Strong organizational skills with high attention to detail and ability to manage multiple priorities.
  • Analytical/problem-solving skills with ability to identify gaps and drive resolution.
  • Ability to work cross-functionally and communicate effectively across levels of the organization.
  • Proficiency with Microsoft Office (Excel, Word, PowerPoint) and document control systems.
  • Medical device or other regulated industry experience preferred.
Education
  • B.S. in engineering or an alternative Bachelor's degree program
  • 3-5 years of experience required in a Quality Engineering role, preferably supporting CAPA processes
  • Knowledge of FDA QSR (21 CFR 820), ISO 13485, and ISO 14971 preferred.
  • Knowledge of design controls, risk management, FMEA, CAPA, root cause investigation and statistical analysis.
  • Certified Quality Engineer (CQE) and Medical device, particularly Orthopedic industry, experience preferred
TekWissen Group is an equal opportunity employer supporting workforce diversity.

About the Company

T

TekWissen LLC

WE THE TEKWISSEN PEOPLE

TekWissen offers you a broader portfolio of services, industry-leading solutions, and the meaningful innovations that give you greater flexibility and speed to respond to market dynamics, reduced costs and risk to improve enterprise performance, and increased productivity to enable growth.

To keep pace with global market demands, TekWissen keeps its finger on the pulse of change. Our organized approach to guiding a project from its inception to closure. Managing projects is becoming more and more important as we enter the digital era. To cope with the pace that this transition demands, a method is required to manage projects so they can yield quality work, while incorporating efficient use of time and resources.

Project involves identifying which quality standards are relevant to the project and determining how to satisfy them.

It is important to perform quality planning during the Planning Process and should be done alongside the other project planning processes because changes in the quality will likely require changes in the other planning processes, or the desired product quality may require a detailed risk analysis of an identified problem. It is important to remember that quality should be planned, designed, then built in, not added on after the fact.

Capabilities and accomplishments in one TekWissen business enhance the opportunity for success in the others. Put simply, TekWissen's unique combination of attributes promotes success.



COMPANY SIZE
100 to 499 employees
INDUSTRY
Computer/IT Services
FOUNDED
2009
WEBSITE
http://www.tekwissen.com/

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