Kaztronix LLC · 4 hours ago
Senior Quality Engineer
Raynham, MA
Full-time
Onsite
Mid, Senior Level
4+ years expKaztronix LLC is seeking a Senior Quality Engineer to ensure compliance with global regulations and standards in the Medical Devices industry. The role involves conducting investigations, analyzing quality metrics, and collaborating with various teams to enhance quality processes and compliance.
ConsultingInformation TechnologyStaffing Agency
Hiring Manager
Danny Wolford
Responsibilities
Champions compliance with applicable Global Regulations and standards (e.g. QSRs, ISO, EN and Medical Device Directive (MDD) requirements), including providing support during internal and external audits
Conducts investigation, bounding, records documentation, review and approval of non-conformances, CAPAs and customer complaints. Raises quality issues as appropriate
Accountability for material identification, material segregation, classification of defect types including the successful application of these techniques on a day-to-day basis in manufacturing
Analyzes/reviews effectiveness of preventive and corrective actions. Review root cause investigation according to an established process
Accountability and ownership of Quality metrics including maintenance and reviewing of leading and lagging indicators of quality
Represents as a Subject Matter Expert (SME)
Supports or leads in developing validation strategies
Approves 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
Collects data and executes/conducts various analytical/statistical analysis and interpretation as part of process improvements and day-to-day support
Documents, justifies, reviews or analyzes whether a proposed change to a process will not enhance the risk level in some way beyond capability of current controls or whether change will result in potential non-compliance to a required standard such as the QSRs
Qualification
Required
A Bachelor's degree or equivalent in Engineering or related scientific field is required
A minimum of four (4) years of relevant professional work experience in the Medical Devices industry
Strong knowledge of quality management systems and regulatory requirements (e.g., ISO 13485, FDA QSR)
Exceptional problem-solving and analytical skills, with the ability to identify root causes and implement effective solutions
Excellent communication and interpersonal skills, with the ability to collaborate effectively with cross-functional teams
Experience with CAPAs non-conformances, audits, and process validation
Strong trending and data analysis skills
Troubleshooting expertise
Proven competence to evaluate, communicate, and act upon significant risks, demonstrating leadership of the high standards of quality and compliance
Act with speed, flexibility, and accountability to achieve goals. Understands how own work impacts the enterprise and use understanding to make effective decisions and take actions and lead priorities effectively to deliver expected results
Preferred
Process Excellence / Six Sigma Certification or equivalent
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