Assist in development and revisions of Standard Operating Procedures (SOP), Work Instructions (WI) device history records, or other quality documentation, as necessary, to support production processes.
Provide guidance in problem diagnosis and resolution with team members.
Assemble, test, and repair work per established work instructions, policies and procedures.
Responsible for successful completion of all training in a timely fashion.
Communicate with quality and facilities any time there is an issue with the product or equipment.
Maintain an organized and professional workspace.
Comply with EHS and Quality procedures, regulations and policies.
Assemble and test medical device assemblies, final products, and accessories per the manufacturing documentation provided. Perform assembly diagnosis, repair, and test equipment maintenance with supervision. Ensure work is completed in compliance with company quality system and medical device regulations.
Performs assembly diagnosis and repair.
Operating within standard operating procedures (SOPs) and assembly drawings.
Ability to work scheduled or expanded shifts, holidays and/or off-shift duties, as necessary.
SAP skills and experience.
Capability to train other production assemblers as needed.
Bachelor’s degree in engineering or related scientific field. Associate’s degree with 2+ years’ experience or High School Diploma with 6+ years of experience in similar position.
Ability to work independently and motivate staff to meet required deadlines.
Six Sigma belt or LEAN ideology.
Notifies area Supervisor and or Team Lead of quality concerns.
This position has achieved more advanced troubleshooting and diagnostic ability related to product performance and may be assigned other more advanced job tasks.
Experience working in cGMP setting and controlled documentation
Problem solving and process improvement skills.
Strong attention to detail, while multi-tasking under strict deadlines.