Quality Assurance Regulatory Affairs Specialist
3.
3 Quick Apply Full-time 6 hours ago Full Job Description Quality Assurance / Regulatory Affairs Specialist If you have a holistic team approach to improve quality, we want to develop you! If you can drive quality improvements through creating and enhancing processes, while positively influencing and interacting with production employees, then you should be successful at Oakworks.
Oakworks has an opportunity if you have quality assurance and regulatory affairs experience in a medical device manufacturing environment.
The Quality Assurance and Regulatory Affairs Specialist delivers quality initiatives and acts as a change agent in the organization (The role is QA 65% & RA 35%).
This role is analytical and hands-on and is responsible for our regulatory requirements, internal audits, document control and CAPA processes and continuous improvement of our processes.
Additional responsibilities include training.
Bachelor's Degree or Equivalent ideally in sciences e.
g.
engineering or another relevant scientific discipline.
Five years of professional experience in QARA; quality management systems relating to medical devices (FDA 21CFR 820, ISO 13485, ISO 14971).
Lead auditor certification preferred.
Advanced computer skills, trending analysis, project and Quality System software experience (QT9 preferred) are required.
Physical requirements include the ability to sit/stand/walk for extended periods of time.
Hours and Status:
The normal schedule is Monday through Friday with some flexibility on start and end times.
This is a full time, benefits eligible position.
About Oakworks:
Oakworks brings high quality, innovative products to the health and wellness market.
As a leading manufacturer of Medical & SPA products we're proud to support customer and employee wellness.
Since its beginning in 1977, Oakworks has maintained a commitment toward environmental conservation and is conveniently located in New Freedom, PA between York, PA and Baltimore, MD.
We invite you to join our team! Quick Apply.
Estimated Salary: $20 to $28 per hour based on qualifications.
3 Quick Apply Full-time 6 hours ago Full Job Description Quality Assurance / Regulatory Affairs Specialist If you have a holistic team approach to improve quality, we want to develop you! If you can drive quality improvements through creating and enhancing processes, while positively influencing and interacting with production employees, then you should be successful at Oakworks.
Oakworks has an opportunity if you have quality assurance and regulatory affairs experience in a medical device manufacturing environment.
The Quality Assurance and Regulatory Affairs Specialist delivers quality initiatives and acts as a change agent in the organization (The role is QA 65% & RA 35%).
This role is analytical and hands-on and is responsible for our regulatory requirements, internal audits, document control and CAPA processes and continuous improvement of our processes.
Additional responsibilities include training.
Bachelor's Degree or Equivalent ideally in sciences e.
g.
engineering or another relevant scientific discipline.
Five years of professional experience in QARA; quality management systems relating to medical devices (FDA 21CFR 820, ISO 13485, ISO 14971).
Lead auditor certification preferred.
Advanced computer skills, trending analysis, project and Quality System software experience (QT9 preferred) are required.
Physical requirements include the ability to sit/stand/walk for extended periods of time.
Hours and Status:
The normal schedule is Monday through Friday with some flexibility on start and end times.
This is a full time, benefits eligible position.
About Oakworks:
Oakworks brings high quality, innovative products to the health and wellness market.
As a leading manufacturer of Medical & SPA products we're proud to support customer and employee wellness.
Since its beginning in 1977, Oakworks has maintained a commitment toward environmental conservation and is conveniently located in New Freedom, PA between York, PA and Baltimore, MD.
We invite you to join our team! Quick Apply.
Estimated Salary: $20 to $28 per hour based on qualifications.
|
|
 | |
