Quality Engineer Technician

The Quality Engineering Technician is instrumental in supporting, implementing, and maintaining quality systems, conducting rigorous tests and inspections, and providing essential technical support for quality improvement initiatives.

This role is pivotal in ensuring product quality and reliability through comprehensive data analysis, problem-solving, and process improvement strategies.

The technician now also plays a crucial role in supporting customer teams, managing Epicor specifications, and engaging in continuous improvement and quality management activities.

Additionally, this role involves monitoring compliance with regulatory requirements, training users on procedures, and providing technical support.

DUTIES & RESPONSIBILITIES

Quality Engineering Support:

• QMS Implementation and Maintenance: Assist with the implementation and upkeep of quality management systems to align with industry standards and regulations.
• Product Inspections and Testing: Conduct thorough inspections and tests to ensure product, component, and material conformity with specifications.
• Data Analysis for Quality Improvement: Perform statistical analyses to identify quality trends and improvement opportunities.
• Quality Issue Investigation: Support the investigation of quality issues and non-conformances, employing root cause analysis and CAPAs.
• Equipment Calibration and Maintenance: Assist in maintaining and calibrating test equipment and tools for optimal performance.
• Quality Audits: Participate in audits to verify adherence to QMS standards and regulatory compliance.
• Quality Documentation Development: Help develop and update quality procedures, instructions, and plans.
• Technical Support: Offer technical guidance on quality issues to production and engineering teams.
• Process and Equipment Validation: Assist in validating processes and equipment to meet quality standards.
• Customer Team/PM Support: Provide assistance and support to customer teams and project managers, ensuring customer requirements are met.
• Implementation and Improvement of Forms and Procedures: Work on the creation and enhancement of quality-related forms and procedures.
• Epicor Spec Management and CO Entry: Manage and enter specifications and change orders in the Epicor system to support quality management.

Additional Responsibilities:

• Performs other related duties and responsibilities as assigned by management to support the overall objectives of the department and organization.

Quality Management and Continuous Improvement:

• Continuous Improvement CI Meeting Report, Minutes/Transcript: Participate in continuous improvement meetings, documenting discussions and action items.
• Training & Mentoring Team: Assist in the training and mentoring of team members in quality practices and methodologies.
• Process Improvement: Engage in initiatives aimed at streamlining reporting and analysis processes to enhance quality management efficiency.
• CAPA and 8D: Manage Corrective and Preventive Actions and utilize 8D problem-solving methodologies to address quality issues.
• QMS Change/New – KACE Management: Support the management and implementation of changes or new additions to the Quality Management System.
• Internal, Customer, and ISO Audits: Participate in internal, customer, and ISO audits, ensuring compliance and quality standards are maintained.

Operational Excellence:

• In addition to managing daily responsibilities with precision and efficiency, the Quality Engineering Technician is expected to actively engage in and contribute to continuous improvement and strategic initiatives aimed at enhancing the department's operations and overall effectiveness.

This includes:

• Customer-Centric Documentation: Developing clear, tailored document control instructions for key customers, enhancing satisfaction and compliance.
• Advanced Training and Development: Upgrading training materials for critical software and processes, ensuring team proficiency and operational efficiency.
• Proactive Workload Management: Utilizing machine load insights to prioritize tasks, enabling ahead-of-schedule preparation and submission.
• Strategic Cross-Functional Collaboration: Strengthening interdepartmental communication and consistency, particularly with international teams, to streamline document control processes.
• Documentation System Enhancements: Implementing system improvements for easier access and management of customer-specific documentation, including the use of golden packages and customer trackers.
• Continuous Improvement: Actively engage in and contribute to continuous improvement and strategic initiatives aimed at enhancing the department's operations and overall effectiveness.

PREFERRED EDUCATION, TRAINING & EXPERIENCE

• Associate or Bachelor’s degree in Engineering, Quality, or related field preferred.
• 1-5 years’ experience in a Quality related field, demonstrating a growing proficiency in quality engineering practices and principles.
• Demonstrated knowledge of Six Sigma tools & Methodologies, with proven ability to apply these techniques to supplier audits and quality improvement projects.
• Familiarity with QA/QC systems and thorough understanding of ISO 13485:2016 and 9001:2015 standards implementations, showcasing the ability to navigate and apply these standards effectively in a manufacturing or production environment.
• Certification in Quality Engineering (e.g., CQE) or Lean Six Sigma Green Belt or above is highly desirable, indicating an advanced understanding of quality principles and methodologies.
• Experience in the medical device or automotive industry is a plus, given the stringent quality requirements and regulatory standards prevalent in these sectors.

PREFERRED KNOWLEDGE, SKILLS & ABILITIES

Technical Proficiency:

• Proficient in utilizing quality engineering tools and methodologies, including Six Sigma and root cause analysis techniques, to improve product quality and process efficiency.
• Demonstrated ability in applying statistical analysis and quality control principles to identify quality trends and improvement opportunities.
• Experience with quality management systems (QMS) software, including Epicor for specification management and change order entry, is highly desirable.
• Familiarity with CAD software and quality inspection tools, with a strong emphasis on blueprint reading, geometric dimensioning and tolerancing (GD&T), and specification comprehension.
• Skilled in MS Office for data analysis and reporting; proficiency in Excel for statistical analysis and PowerPoint for presenting quality findings and improvement plans.

Regulatory & Standards Knowledge:

• Deep understanding of ISO 9001, ISO 13485, and other relevant quality standards and regulations, including cGMP.
• Knowledgeable about CAPA management and the 8D problem-solving process to address and prevent quality issues effectively.
• Awareness of documentation standards and practices to ensure compliance and maintain quality records.

Communication & Interpersonal Skills:

• Excellent communication abilities to effectively convey quality issues, solutions, and improvements across all levels of the organization.
• Collaborative mindset to work within cross-functional teams, providing quality engineering support and guidance.
• Capable of mentoring and training team members on quality tools, processes, and best practices.

Operational Skills:

• Strong organizational skills to manage multiple projects and priorities in a fast-paced environment.
• Detail-oriented with a commitment to accuracy and the ability to identify and address gaps in processes or systems.
• Flexibility to adapt to changing priorities and the resilience to work under pressure while maintaining high-quality standards.

Physical Requirements & Safety:

• Ability to perform physical tasks associated with quality inspections and audits, including lifting up to 25 lbs.
• Commitment to adhering to safety standards and wearing personal protective equipment (PPE) as required in manufacturing and production areas.

WORK ENVIRONMENT

• Office Onsite

HOURS /SHIFTS

• As Assigned

SALARY

• DOE

BENEFITS

• Per current company policy.

Salary : $75,000 - $100,000