Shift Timings: First or second shift so either 8:30 am- 5 pm or 3 -11:30 pm. Flexible
MUST HAVE - mechanical tester experience - Instron or MTS, gage experience. Nice to have Med Device
To provide technical testing and evaluations current products and support for process and product validations.
Perform physical and visual inspection on finished goods and incoming raw materials used in the production of products according to released test methods.
Essential Duties and Position Responsibilities
Perform final physical/visual inspection of all finished products.
Inspect, sample, and perform physical/visual tests on package components and raw materials according to released Standard Operating Procedures.
On time approval of raw materials, sub-assemblies and finished products.
Coordinate with other departments to prioritize inspections as appropriate.
Verify calibrations and maintenance are performed on department equipment at time of use
Set up and operate routine experiments and testing using the appropriate related equipment with minimal supervision.
Set up and operate routine experiments for process validation and product verification using approved protocols and methods.
Instrumentation set up with pressure transducers, flow meters, chart recorders, meters, tensile testers and precision dimensional measurement equipment.
Support and assist in the development of lean thinking programs and participate in the implementation of these programs throughout the facility as required
Maintain a good attendance and on-time record as outlined in the Attendance Guidelines for our facility
Use of Good Documentation Practices Daily.
Assist Quality Engineering with process and product validation testing
The ability to work overtime
Initiate NCMRs as required.
Other duties as assigned
Must be available for Overtime if required.
Qualifications, Knowledge, and Skills Required:
High School diploma or GED required
One or more years of experience working in a medical device or other regulated industry
Mechanical inspection experience (Tensile testing, peel testing, Instron or MTS equipment or equivalent) required
Duties require knowledge of cleanroom gowning and work environment.
Must have ability to read, write, interpret, comprehend, and consistently follow specifications written in English
Computer literacy particularly with databases and spreadsheets / basic ability to use Microsoft Office required
Duties require basic knowledge of math
Duties require knowledge of inspection/sampling techniques and familiarity with ANSI/ASQZ1.4, ISO-9000 and ISO13485.
Duties require basic knowledge of mechanical and physical inspection techniques. (Calipers, micrometers, blueprint/artwork reading, etc.)
Basic understanding of Good Manufacturing Practices (GMP) and Quality System Regulations (QSR)