Job Description
Job Description
Salary : $70,000-90,000 / yr DOE
Ready to Transform Your Career? Join SpiTrex 3D!
Are you looking to be part of a dynamic team in the cutting-edge world of additive manufacturing? Do you thrive in a fast-paced, growing environment that blends high technology and USA manufacturing? If so, we have the perfect opportunity for you!
We are a leading additive manufacturing company located in vibrant Carlsbad, California. Our innovative solutions are revolutionizing the industry, and we're seeking a talented Quality System and Assurance Specialist to join our growing team. Imagine a workplace where your growth knows no bounds - where data drives success, and your career flourishes. We believe SpiTrex 3D is a workplace like no other. It is a place to be challenged, explore your curiosity, and grow your career.
Job Overview :
As a Quality System and Assurance Specialist at SpiTrex 3D, you will play a crucial role in ensuring the highest standards of quality for our 3D printed products and services. Your focus will be on supporting the Quality System, such as Supplier Quality, Investigation Systems, Quality Event Reporting, Training Records, and Document Review, as well as Finalizing Production Records, such as critical Master Batch Records (MBRs) and Certificates of Conformances.
Reports to :
Quality System and Assurance Supervisor.
Essential Functions :
- Company Culture and Mission :
Consistently apply core values (Integrity, Impact, Dedication) to your decision-making process and interactions with others.
Uphold and contribute to the companys quality policy commitment.Quality Management SystemProcesses :Support the QM, SOP, WI system within the company Document Control Process.
Support the internal and external audit plans and reports per applicable standards. Review corrective actions, aiding in audit preparation, and implementing necessary measures as needed.Support data entry analysis and tracking for Quality Managements System modules by creating graphs and reports to ensure timeliness and effectiveness as needed.Deviations and Nonconformances :Support the review, approve and monitor events and deviations. Handling complaints, investigations, and cross-functional support for closing Quality events as needed.
Supply / Vendor Management : Support supplier qualification, reassessment activities, quality agreements, and quality score cards. Oversee the process is maintained and approved according to processes.Quality Metrics : Support trending analysis and reporting of quality indicators. Identification or risk and process improvements into operations as needed.Master Batch Records :Prepare master batch record job folders for new production builds
Support and organize records and data entries to allow for approvals in a timely manner with an accurate compilation of product Master Batch Records, which include Certificates of Conformance.Assist in verifying manufacturing scheduling to ensure that all quality activities are occurring at or ahead of schedule.Using Microsoft Word, Excel, and JobBoss2 document and record data entries in cooperation with handwritten records.Review executed records for compliance, ensuring completeness of all necessary testing and documents across various processes as neededQuality Control Records :Archive, physical retains, printed records, and electronic records with scanning, filing, and sorting per quality standards when needed.
Ensure product processes adhere to established quality standards and guidelines.Support data collection and monitor data throughout the production process where needed.Defect Detection / nonconformances :Collaborate and support the identify and document defects, nonconformances, or deviations from quality standards.
Work closely with quality and production teams to address and resolve quality issues promptly.Support corrective actions to prevent recurrence of defects as needed.Training and Education :Stay updated on industry trends, quality standards, and regulations as needed.
Support the maintenance of training records and training matrixes.CommunicationEffectively communicate quality related information to supervisors, colleagues, and other relevant stakeholders.
ComplianceComply with ISO 13485 Quality Management System, FDA 21 CFR Part 820 Quality System Requirements (QSR), and medical device industry requirements.
Assist in the implementation of the quantity management system.Other work-related tasks as assigned.Competency :
Understanding of quality control principles and inspection techniques.Strong understanding of GMPs for production and generation of batch records.Basic familiarity with mechanical testing and materials characterization.Excellent organizational skills.Basic understanding of engineering drawings and specifications.Problem-solving skills.Organizational and time management skills.Very strong attention to detail.Strong commitment to safety and quality assurance.Effective communication and interpersonal skills to work with cross-functional teams.Education and Experience :
Associate degree in related field and / or 18 months-4 years experience preferred.Experience in quality control in the medical device industry, aerospace, or automotive industry preferred.Experience with mechanical testing and materials characterization preferred.Experience with inspection equipment, such as calipers, micrometers, and height gauges preferred.Experience using inspection equipment, such as calipers, micrometers, and height gauges preferred.Benefits Include :
Medical, Vision and Dental InsuranceShort Term Disability401(k) plus matchVacation daysPaid holidays
Salary : $70,000 - $90,000
