QA Engineer III - Integrated Resources, Inc
Greenville, SC 29611
About the Job
Job Title: QA Engineer III
Location: Greenville, SC 29611
Duration: 12 Months+
Shift Hours: 8 AM to 5 PM (Mon - Fri)
Job Description:
Roles and Responsibilities:
Qualifications:
Location: Greenville, SC 29611
Duration: 12 Months+
Shift Hours: 8 AM to 5 PM (Mon - Fri)
Job Description:
- Looking for someone with medical device experience. (anyone from a big med device company) Root cause analysis.
- Candidate will coordinate with engineering manager as well.
- Software validation & involved in the design process of medical device.
- Who is comfortable with Auditing FDA & ISO.
- Pure manufacturing facility in Greenville, SC. 4 people in Quality team.
Roles and Responsibilities:
- Designs, implements and maintains quality assurance protocols and methods for processing materials into partially finished or finished products.
- Responsible for planning, implementing and managing compliance of manufacturing and production processes with internal and external safety, quality and regulatory standards requirements for worldwide distribution.
- Designs methods and procedures for inspecting, testing and evaluating the precision and accuracy of production processes, production equipment and finished products.
- Performs analysis of reports and production data to identify trends and recommend updates or changes to quality standards and procedures when necessary.
- May assure compliance to in-house and/or external specifications and standards (i.e. GLP, GMP, ISO, Six Sigma).
Qualifications:
- At least 3 years of experience required.
- Bachelors required (Science is preferred).
- Working with CAPA Managing risk management IVDR, ISO 1345, 21CFR 820 need to do.
- Good at presenting data and willing to work with everyone on the floor for corrective action.
- They will be coordinating with cross functional teams.
Source : Integrated Resources, Inc
