Quality Senior Engineer I

TekWissen LLC

Job Location:

Englewood, CO - USA

Monthly Salary: Not Disclosed

Posted on: 13 hours ago

Vacancies: 1 Vacancy

Job Summary

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 Bachelors 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.

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 artifi...

Overview:

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 Bachelors 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.