Job Title: Quality Technician (2nd Shift)Job DescriptionThe Quality Technician (2nd Shift) performs incoming, in-process, and final inspections of components and assemblies in accordance with established control and quality plans. This role reviews and approves final release documentation, completes all required quality records within company and GMP guidelines, and ensures materials meet engineering and regulatory standards before they move forward in the production process.
Responsibilities- Perform incoming inspections of received materials in accordance with control and quality plans, ensuring conformance to engineering drawings, schematics, specifications, and process standards.
- Conduct in-process and final inspections of components and assemblies, verifying compliance with production and process plans.
- Review and approve final release documentation to support product release decisions.
- Inspect incoming or production materials for conformance to engineering drawings, schematics, specifications, and process standards, following IPC-A-610 guidelines where applicable.
- Perform incoming tests of components and monitor results for conformance to design, test specifications, and applicable standards.
- Accept or reject materials or articles based on inspection results, clearly identifying and documenting non-conformances and notifying appropriate personnel of potential rejections.
- Refer and document unusual inspection problems to supervision, leads, or Project Quality Engineers for resolution.
- Use a variety of measuring tools, including electrical test sets, multimeters, fixed gauges, limit and plug gauges, steel rules, scales, micrometers, calipers, and surface plates, to verify product dimensions and performance.
- Assist in writing and updating inspection procedures, protocols, and checklists to improve consistency and effectiveness of quality processes.
- Transfer, release, or quarantine material physically according to inspection status and established procedures.
- Document and maintain accurate inspection and test records in line with GDP and GMP requirements and company policies.
- Apply a strong understanding of product conformity, lot numbers, and traceability to maintain robust quality assurance and tracking.
- Follow ISO quality assurance standards and maintain related documentation to support compliance and audits.
- Maintain a safe and clean work environment by keeping shelves, workstations, and equipment neat and organized, and by complying with all procedures, rules, and regulations.
- Complete all required paperwork and documentation accurately and in a timely manner.
- Collaborate with team members, engineers, and other departments to resolve quality issues and support continuous improvement.
Essential Skills- Ability to read and understand mechanical drawings and dimensions.
- Ability to read and interpret drawing notes and understand configuration management, including revision control.
- Proficiency in using basic measuring tools such as calipers, go/no-go gauges, torque wrenches, micrometers, and related instruments.
- Experience with quality control processes, including visual inspection and handling non-conforming materials.
- Knowledge of medical device manufacturing practices and requirements.
- Working understanding of Good Documentation Practices (GDP) and Good Manufacturing Practices (GMP).
- Excellent documentation skills with strong attention to detail and accuracy.
- Ability to comprehend written work instructions and follow standard operating procedures (SOPs).
- Strong math fundamentals for measurement, tolerance, and data interpretation.
- Good communication skills, both written and oral, with the ability to work effectively as a team player.
- Organizational skills to manage multiple inspections, records, and tasks simultaneously.
- Ability to understand and apply ISO quality assurance standards and related documentation.
- Understanding of product conformity, lot numbers, and traceability requirements in a regulated environment.
Additional Skills & Qualifications- Experience with electrical test sets, multimeters, and vision measuring systems is a plus.
- Experience working with an ERP system and performing accurate data entry.
- Proficiency with Outlook and Microsoft Office applications for communication and record keeping.
- Familiarity with microscopes and other precision inspection equipment used in quality control.
- IPC-A-610 certification is recommended for inspection of electronic assemblies.
- Ability to multitask, remain flexible in a dynamic production environment, and collaborate effectiv