Transfers developed manufacturing methods into work instructions and associated training for transfer into production.
Develops required maintenance and calibration instructions for manufacturing equipment and creates required equipment documentation.
Provides assistance for equipment design for producing medical devices and components.
Assists with process development and validation including IQ, OQ, and PQ.
Assists with process improvement initiatives.
Participates in non-conformance investigations, CAPA activity, and equipment troubleshooting.
Executes change orders (ECO's, DCO's) related to process and equipment documentation.
Analyzes and documents test results for development and pilot production runs.
Specifies and executes equipment and tooling verifications and equipment acceptance tests. Contributes to the team effort by accomplishing related tasks as necessary.
Required Knowledge, Skills and Abilities:
A demonstrated knowledge and understanding of Quality Assurance Methods and good analytical and problem solving skills are required.
The ability to organize, prioritize and adapt.
Multi-tasking capabilities in a fast paced environment.
Experience working with FDA requirements preferred.
Experience working within a medical manufacturing environment preferred.
Working knowledge of statistical process control and lean manufacturing preferred.
Working knowledge of computer aided drawings (CAD) preferred.
Minimum Requirements:
Bachelor's Degree in Engineering, or equivalent work experience.
Highly skilled in troubleshooting, problem solving and analysis.
Working knowledge of MS Office applications (Word/Excel) is required.
Getinge is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity,
pregnancy, genetic information, national origin, disability, protected veteran status or any other characteristic protected by law.
If you share our passion and believe that saving lives is the greatest job in the world, then we look forward to receiving your application. We hope you will join us on our journey to become the world's most desired medtech company.