Quality Control Inspector-SAN-NEH-002

Company: Software Galaxy Systems, LLC
Location: Marlborough
Posted on: April 17, 2025

Job Description:

Location : Marlborough, MA

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Contract : 6 Months + (Possibilities chance of extension)
We are seeking an experienced Quality Control Inspector to join our team in Marlborough, MA. We need someone who is having previous experience in quality assurance or manufacturing. The candidate should be able to work under FDA regulated medical device environment. Ideal candidate should be able to perform inspections, checking, testing and sampling procedures for product manufacturing processes. Carrying out packaging line, manufacturing inspections and sampling and testing of incoming components and raw materials to ensure that company standards are met. He should be responsible for review and release of Device History Records, monitorinh critical equipment and instrumentation and may assist with validating or troubleshooting testing methods, including assays.

Job Responsibilities:

The incumbent may be asked to perform other function-related activities in addition to the below mentioned responsibilities as reasonably required by business needs.
Maintain and promote a safe work environment at all times. Identify, address, and react to any unsafe or hazardous situation.
Conduct inspections, including work in process and final inspection of finished goods to ensure manufactured products conform to specifications. Proficient in identifying and documenting defects, and corrections required.
Record and maintain quality control records documenting testing and inspections.
Participate in investigations into non-conforming products and corrective actions.
Perform manufacturing process audits to ensure correct adherence to Standard Operating Procedures (SOPs) and Work Instructions.
Initiate Non-Conforming Events (NCEs) within the Quality Management System and assists with investigations relating to non-conforming products.
Responsible for cleaning, calibrating, and maintaining quality assurance equipment.
Performs daily reviews of in-process and final test device history records and sales orders.
Performs inspections to determine pass/fail criteria.
Participate in Kaizen events and other continuous improvement initiatives.
Complete all training requirements in a timely manner and maintain accurate training records.
Regular and punctual attendance. Ability to adhere to standardized production schedule for position and ability to work overtime to support production needs as necessary.


Skills:

Knowledge of Microsoft Office platform including Excel, Word, SharePoint, and OneDrive required.
Ability to read, understand, and follow all written procedures.
Ability to communicate effectively, both written and verbally.
Ability to work both independently and as a member of a team.
High-level of attention to detail and focus on quality.
Detail oriented and accurate.
Ability to use quality control tools such as measuring tapes, calipers, micrometers, scales, gauges, microscopes, etc.
Ability to read and interpret basic schematics and blueprints required to ensure proper assembly.
Understanding of GMP (Good Manufacturing Practices) and GDP (Good Documentation Practices)


Education/Experience:

Preferred Minimum Non-Technical Degree: 1-2 Years
Experience with Oracle ERP or Agile Product Lifecycle Management System is beneficial.
Previous quality assurance or manufacturing experience is beneficial.
Experience in an FDA regulated medical device environment is beneficial.
Preferred Minimum Non-Technical Degree: High School (H.S./GED) or Associate Degree

Keywords: Software Galaxy Systems, LLC, Plymouth , Quality Control Inspector-SAN-NEH-002, Other , Marlborough, Massachusetts