Quality Control & Inspections: Conduct product testing, material inspections, and equipment calibration to ensure absolute alignment with technical specifications.Problem Solving & CAPA: Investigate quality non-conformances using root cause analysis, 8D methodologies, and Corrective/Preventive Actions (CAPA).Auditing & Compliance: Participate in internal, customer, and ISO audits to maintain strict regulatory compliance and upkeep QMS standards.Data Analysis & Systems Management: Perform statistical trend analysis, execute process validations, and manage data entry (specifications and change orders) within Epicor and KACE systems.Documentation & Continuous Improvement: Create and streamline customer-centric documentation, procedures, and forms. Participate in continuous improvement (CI) initiatives and document meeting outcomes.Collaboration & Support: Provide technical guidance to production and engineering teams, support project managers, and assist in training and mentoring team members
1-4 years
Technical Skills & MethodologiesQuality Engineering Tools: Proficient in utilizing quality engineering tools and methodologies, including Six Sigma and root cause analysis techniques, to improve product quality and process efficiency.Statistical Analysis: Demonstrated ability in applying statistical analysis and quality control principles to identify quality trends and improvement opportunities.Technical Design & Inspection: Familiarity with CAD software and quality inspection tools, with a strong emphasis on blueprint reading, geometric dimensioning and tolerancing (GD&T), and specification comprehensSoftware Proficiency: Skilled in MS Office for data analysis and reporting; proficiency in Excel for statistical analysis and PowerPoint for presenting quality findings and improvement plans.Standards & Regulations: Deep understanding of ISO 9001, ISO 13485, and other relevant quality standards and regulations, including cGMP.?-Problem-Solving: Knowledgeable about CAPA management and the 8D problem-solving process to address and prevent quality issues effectively.?-Documentation: Awareness of documentation standards and practices to ensure compliance and maintain quality records.Soft Skills & Workplace Competencies?-Communication: Excellent communication abilities to effectively convey quality issues, solutions, and improvements across all levels of the organization.?-Collaboration: Collaborative mindset to work within cross-functional teams, providing quality engineering support and guidance.?-Mentorship: Capable of mentoring and training team members on quality tools, processes, and best practices.?-Organization: Strong organizational skills to manage multiple projects and priorities in a fast-paced environment.?-Attention to Detail: Detail-oriented with a commitment to accuracy and the ability to identify and address gaps in processes or systems.?-Adaptability & Resilience: Flexibility to adapt to changing priorities and the resilience to work under pressure while maintaining high-quality standards.Physical & Safety Requirements?-Physical Tasks: Ability to perform physical tasks associated with quality inspections and audits, including lifting up to 25 lbs.?-Safety Standards: Commitment to adhering to safety standards and wearing personal protective equipment (PPE) as required in manufacturing and production areas.
Technical SkillsQuality Systems & Auditing: Knowledge of QMS implementation, ISO standards, and internal/customer audit processes.Problem-Solving Methodologies: Proficiency in Root Cause Analysis, 8D, and CAPA (Corrective and Preventive Actions).Inspections & Metrology: Experience with product testing, material inspections, and tool calibration.Data Analysis & Systems: Ability to perform statistical analysis and utilize ERP/software tools (specifically Epicor and KACE).Technical Documentation: Skill in reading engineering specifications and drafting QA procedures, forms, and instructions.Professional & Soft SkillsCross-Functional Communication: Ability to collaborate effectively with engineering, production, project managers, and international teams.Training & Mentoring: Capability to coach and onboard team members on quality processes.Proactive Workload Management: Organizational skills to prioritize tasks and meet production schedules ahead of time.
Bachelors
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