Kaztronix LLC · 7 hours ago
Quality Analyst
Raynham, MA
Full-time
Onsite
New Grad, Entry Level
0+ years expKaztronix LLC is a company focused on quality assurance programs and controls. The Quality Analyst role involves establishing quality assurance procedures, supporting LIMS operations, and ensuring compliance with regulatory standards while collaborating with various teams to improve product quality and processes.
ConsultingInformation TechnologyStaffing Agency
Responsibilities
Comply with company policies, procedures, and quality standards, as well as safety and environmental regulations
Develops solutions to database problems of basic scope and complexity. Assists in writing standard operating procedures related to inspection process and LIMS system operation
Provides backup support to product review and LIMS release functions. Provides backup to good manufacturing practice auditing
Directly responsible for the migration of Inspection Plans and master data into Labware and Labvantage LIMS
Collaborates with inspectors and outside stakeholders on Inspection plan optimization and clarifications in LIMS or other system as applicable
Provides support on day-to-day operation of LIMS, assisting users with issues related to the system, troubleshooting, problem-solving, reports or other as applicable
Provides LIMS training to applicable personnel meeting company regulations, guidelines, and procedures
Facilitates and monitors LIMS access to applicable personnel as per training requirements and user access requirements
Supports LIMS Change Control Activities for inspection plans or new implementations
Collaborate with other LIMS administrators to perform improvements to LIMS procedures, master data creation and system handling
Works with IT, Business, and/or Technical Quality responsible parties to escalate LIMS issues
Monitors LIMS appropriate use and performance as required
Support quality improvement initiatives such as process and product characterizations that lead to continuous / cost improvements
Conduct benchmarking to develop more effective methods for improving quality
Supports base business, new product introductions, and overall product life cycle management
Review/analyze whether current product and processes comply to standards such as the QSRs, ISO 13485, etc
Champions compliance to applicable Global Regulations and standards (e.g. QSRs, ISO, EN and Medical Device Directive (MDD) requirements) including providing support during internal and external audits
Conduct periodic line audits to assess for production controls such as lot segregation. Review results of area audits to ensure that corrective and preventive actions are adequate
Partners with R&D and other Multi-functional partners to ensure the proper application of design controls, risk management and the investigation/correction of design failures/challenges
Ensures RI insights and best practices are considered during creation/updates of new inspection plans
Supports new product introduction as part of design transfer
Supports activities related to the Material Review Board
Conduct investigation, bounding, documentation, review, and approval of non-conformances. Escalation of quality issues as appropriate
Supports material identification, material segregation, classification of defect types including the successful application of these techniques on a day-to-day basis in the laboratory
Aids in the accountability of Quality metrics including maintenance and reviewing of leading and lagging indicators of quality
Draft, Approve, Execute IQ, OQ, PQ, TMV or Software Validation
Partners with Global Supply chain, Finished Goods, and material suppliers to ensure appropriate application of process validation, process control, and risk management; and the investigation/correction of process failures when needed
Develop, interpret and implement appropriate process monitoring and control methods consistent with the level of process/product risk
Collect data and execute/conduct various analytical/statistical analysis and interpretation as part of process improvements and day-to-day support
Develop, interpret, and implement standard and non-standard sampling plans
Assess effectiveness of measurement tools, destructive tests, non-destructive tests, measurement system analysis
Responsible for communicating business related issues or opportunities to next management level
Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures
Performs other duties assigned as needed
Qualification
Required
University/bachelor's degree or Equivalent
Generally, Requires 0-2 Years Work Experience
Good technical understanding of manufacturing equipment and processes
Good understanding of company GDP and Quality procedures related to software handling
Strong/Advanced Spreadsheet (e.g. Excel) skills
Inspection knowledge, including basic GD&T skills
Low to Intermediate experience using the Labware LIMS Version 7 platform
Low to Intermediate experience using the LabVantage Version 8.8 platform
Low to Intermediate experience in setting up Master Data from one platform to another
Preferred
Six months or more of work experience in a manufacturing environment
Strong knowledge and ability to preview, graph and analyze data and be able to present data that facilitates/drives decision-making
The ability to perform 'hands on' troubleshooting and problem-solving
The ability to think on the feet and providing sound judgment
Understanding of GMP/ISO regulations and validation regulations
Advanced knowledge and experience in the areas listed in the Duties and Responsibilities associated with the position
Company
Kaztronix LLC
Kaztronix is a staffing and recruiting company that provides specialty consulting solutions.
201-500 employees
H1B Sponsorship
Kaztronix LLC has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (2)
2022 (1)
Funding
Current Stage
Growth StageLeadership Team
Michael Kasmir
Managing Member & Co-Founder
Company data provided by crunchbase