Quality Inspector
Location: Marlborough, MA
Onsite Flexibility: Onsite
Contract Details
- Position Type: Contract
- Contract Duration: 6 months (extension possible; conversion potential to be determined later this year)
- Pay Rate: $25.00 / Hour (USD)
- Work Authorization: Applicants must be authorized to work for ANY employer in the U.S. We are unable to sponsor or take over sponsorship of an employment Visa at this time.
Job Summary
The Quality Inspector will perform detailed inspection and documentation review activities in support of final product release, in-process quality oversight, and regulatory compliance within a medical device manufacturing environment. The incumbent may be asked to perform other function-related activities in addition to the listed responsibilities as reasonably required by business needs.
Key Responsibilities
- Perform detailed reviews of Device History Records (DHRs) as part of final inspection and release activities for finished products, ensuring accuracy and compliance with documentation standards.
- Conduct reviews of manufacturing records for replacement components, subassemblies, and in-process inspections to ensure alignment with quality requirements.
- Support manufacturing personnel by ensuring proper documentation of Failure Investigation Reports and processing of Non-Conforming Materials in the Product Lifecycle Management (PLM) system, including identification, quarantine, and documentation.
- Perform routine inspections, including field service and special inspections, to support validations, studies, and incoming inspection activities.
- Communicate and reinforce Good Manufacturing Practices (GMP) to manufacturing personnel to uphold quality standards.
- Review and provide input on new releases of Inspection and Test documents to ensure adherence to Good Documentation Practices (GDP).
- Maintain QA Activity Collection Plans, First Pass Yield reports, and other applicable tracking mechanisms to monitor quality metrics.
- Collaborate with Engineering to provide feedback on documentation improvements and process changes.
- Support Incoming, product returns, and calibration teams as needed.
- Perform other duties as assigned by leadership to meet organizational and operational needs.
- Ensure compliance with all company policies and procedures, including safety regulations, Personal Protective Equipment (PPE) requirements, Standard Operating Procedures (SOPs), Quality Management System regulation (QMSR), ISO standards, and Good Documentation Practices (GDP).
- Demonstrate a strong commitment to the company's core values, including integrity, respect, collaboration, and innovation.
- Actively contribute to a positive and inclusive work environment, supporting colleagues and promoting a culture of mutual respect and teamwork.
- Engage in continuous improvement initiatives, striving for operational excellence and efficiency.
- Promote sustainable practices within the workplace, including waste reduction, recycling, and energy conservation.
- Participate as applicable in workshops, training sessions, and other activities aimed at fostering a culture of continuous improvement and lean thinking.
- Participate in regular training and complete all training on time.
Required Skills
- Strong attention to detail and accuracy in reviewing documentation and inspection processes.
- Knowledge of Quality Documents and processes.
- Ability to work independently with minimal supervision and make informed decisions.
- Excellent interpersonal and communication skills for effective collaboration across teams.
- Thorough understanding and application of Good Manufacturing Practices (GMP) and Good Documentation Practices (GDP).
- Familiarity with quality management systems (QMS) and regulatory requirements in the medical device industry.
- Ability to interpret engineering drawings, specifications, and technical documentation.
- Proficient in using quality tools, metrics, and software systems, including Oracle and Agile (preferred).
- Organizational skills to maintain accurate records, logs, and reports.
- Commitment to continuous improvement and fostering a culture of operational excellence.
- Basic computer skills.
Preferred Skills
- Experience with Oracle and Agile preferred.
Education Requirements
- High school degree and/or an equivalent technical school education preferred.
Required Experience
- Minimum of 3 to 5 years of related Quality Inspection experience in a Medical Manufacturing environment.
Work Environment / Physical Requirements
- Sit; use hands or fingers to handle or feel objects, tools, or controls.
- Stand; walk; reach with hands and arms; and stoop, kneel, crouch, or crawl.
- Lifting/pushing/pulling and carrying products weighing up to 45 pounds.
- Potential exposure to moving mechanical parts, vibration, and/or moderate noise levels.
- Potential exposure to hazardous chemicals or other materials.
- Safety shoes compliant with site-specific policies/procedures must be worn in designated areas.
- Potential exposure to blood.
- Exposure to biological specimens (biohazards).
- Hepatitis B vaccination required.
Benefits
- Medical, Vision, and Dental Insurance Plans
- 401k Retirement Fund
About the Client
This client is a leading medical device manufacturer operating in the diagnostics and women's health technology space, with on-site manufacturing facilities serving regulated markets across the U.S. The organization employs quality assurance professionals, manufacturing technicians, receiving inspectors, and engineering specialists who collaborate within an FDA-regulated environment governed by GMP, GDP, and ISO standards. With a strong emphasis on compliance and continuous improvement, this manufacturer supports thousands of patients and healthcare providers through its diagnostic and treatment technologies.
About GTT
GTT is a minority-owned staffing firm and a subsidiary of Chenega Corporation, a Native American-owned company in Alaska. We highly value diverse and inclusive workplaces and support Fortune 500 organizations across banking, financial services, technology, life sciences, biotech, utilities, and retail sectors throughout the U.S. and Canada.
Job Number: 26-10461
Industry: Manufacturing & Operations
Pay: $25.00 per hour
Benefits:
- Health insurance
- Vision insurance
Experience:
- QA inspector: 2 years (Required)
- Vision system: 1 year (Required)
- CMM: 1 year (Required)
Work Location: In person
