Quality Engineer Job
BioTouch
Date: 3 weeks ago
City: Columbus, GA
Contract type: Full time
Why You'll Love This Job
The Quality Engineer will be expected to use their training, experience, and good judgement to perform tasks assigned in the Quality Department
Responsibilities
Job Number: 142780
The Quality Engineer will be expected to use their training, experience, and good judgement to perform tasks assigned in the Quality Department
Responsibilities
- Leads the Validation program at BioTouch (Global)- ensures all current process/equipment meet BioTouch Validation program requirements & remediate as necessary
- Ensure all new processes and equipment follow BioTouch Validation Program- Lead activities including authoring and ensuring IQ/OQ/PQs are completed
- Participates in updates to Risk Management, Assists in pFMEA updates and evaluations.
- Leads the CAPA program at BioTouch (Global) including leading CAPA Review Board, and CAPA & Continuous Improvement Projects
- Leads the Supplier Management program: Surveys, Annual Reviews, Metrics, Audits, SCARs
- Assists with updating Quality Metrics as assigned.
- Completes assigned internal audits per the internal audit schedule and as assigned.
- Conducts process walks of procedures with other departments.
- Ability to lead projects and manage tasks as assigned with Global projects.
- Provide back-up coverage for other quality positions as needed.
- Other duties as assigned.
- Thorough knowledge and minimum 5 years’ experience working specifically in a Validation Program, CAPA management, and Supplier Management in a regulated environment such as medical devices and experience with Quality Management Systems and Medical Device Regulations: CFR 820, ISO 13485
- Project Management knowledge and skills
- Ability to prioritize and shift priorities quickly as needed
- Proficient verbal and written communication skills
- Team-oriented with commitment to the success of the team and organizational goals to track and complete assignments
- Basic knowledge of Microsoft Windows & Office
- Ability to use eQMS, WMS systems
- Ability to multi-task
- College degree (Bachelor, may consider equivalent experience) in sciences, Biomedical Engineering, quality management, biology, or similar.
- Must have knowledge and minimum 5 years experience working in a Validation Program and Quality Systems in a regulated environment such as medical devices or pharmaceuticals, and experience with Quality Management Systems and Medical Device Regulations: CFR 820, ISO 13485
Job Number: 142780
How to apply
To apply for this job you need to authorize on our website. If you don't have an account yet, please register.
Post a resumeSimilar jobs
Video Production Coordinator
Columbus Clingstones,
Columbus, GA
3 days ago
Position Overview:The Coordinator, Video Production is a seasonal, full-time position with the Columbus Clingstones based in Columbus, Georgia and will be responsible for leading and overseeing the video production department with the development and creation of a wide range of video projects. This individual will also be assisting in our digital marketing efforts and bringing the Clingstones brand to life....
Property Accountant
Woodruff Property Management Company,
Columbus, GA
$45,000
-
$55,000
per year
4 days ago
We are seeking a detail-oriented and experienced Property Accountant to join our team. The ideal candidate will have a strong background in accounting, with a focus on property management and real estate financials. You will be responsible for managing financial transactions, preparing reports, ensuring compliance with regulations, and providing financial insights for our property portfolio.Key Responsibilities:Financial Reporting & AnalysisPrepare monthly,...
RN - Operating Room, PRN, Days
Piedmont Healthcare,
Columbus, GA
1 week ago
Description:
RESPONSIBLE FOR: The staff nurse provides nursing care to patients from birth through the lifecycle utilizing nursing processes to assess, plan, implement, and evaluate the care for patients. He/she functions within the framework of the policies and procedures of the organization and demonstrates professional growth and accountability. The staff nurse is responsible for maintaining standards of practice, coordinating patient...
