Quality Control Inspector - Intellectt INC

Job Title: Quality Control Inspector I

Location: Lexington, MA, USA, 02421

Duration: 12 Months

Description:

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)