Location: 99 Hayden Ave, Lexington, MA, USA, 02421
Duration: 12 Months
Description:
Summary/Purpose of Position • First or second shift • Either 8:30am- 5pm or 3-11:30pm. Flexible • First or second shift, flexible on that, BUT training happens first shift 7-3 for the first 2 months • 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