A Quality Engineer is responsible for overseeing and implementing quality control processes, procedures, and inspections to maintain and improve product quality. This position will focus on implementing quality control measures, supporting product verifications and process validations, and collaborating with cross-functional teams to drive continuous improvement in the additive manufacturing operations. This position plays a crucial role in ensuring products or processes are consistent in quality, meet customer expectations, comply with industry standards and regulations. These efforts contribute to reducing defects, minimizing rework, and enhancing overall product reliability and customer satisfaction.
Reports to:
Quality Manager.
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 company's quality policy commitment.
?Process/Disposition of Nonconformances:
?Good understanding and previous experience of the processes associated with Nonconformances - documentation, root cause analysis, disposition, recurrence prevention.
?Work closely with quality leadership and production teams to address and resolve quality issues promptly.
?Implement corrective actions to prevent the recurrence of defects as needed.
Quality Control Processes:
?Assist in implementation of robust quality control procedures, work instructions and job aids as assigned.
?Ensure product processes adhere to established quality standards and guidelines.
?Monitor and document data throughout the production process.
?Statistical Analysis and Reporting:
?Basic understanding of general statistical principles.
?Participate in root cause analysis and continuous improvement activities.
?Use statistical methods and quality tools (e.g., Pareto analysis) to identify opportunities for process enhancement.
Calibration and Maintenance:
?Schedule and record calibration and preventive maintenance of equipment to ensure accuracy and reliability.
?Training and Education:
?Train and educate production and quality assurance personnel on quality control procedures and best practices as assigned.
?Stay updated on industry trends, quality standards, and regulations as needed.
Communication
?Effectively communicate quality related information to supervisors, colleagues, and other relevant stakeholders.
Compliance
?Comply 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:
?General knowledge of quality control principles, methods, and tools.
?Ability to read/understand engineering specifications/blueprints.
?Detail-oriented with excellent problem-solving skills.
?Effective communication and teamwork abilities.
?Basic understanding of statistical analysis
?Ability to comply with Quality System Requirements
Education and Experience:
?Bachelor's degree in engineering or a related field (e.g., mechanical engineering, industrial engineering, quality control) or 1-3 years' experience preferred.
?Experience with quality control and quality assurance processes in the medical device industry preferred.
Physical Demands:
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. The employee must occasionally transport or move up to 20 pounds. The employee is frequently required to remain stationary. The employee is required to communicate with others to exchange information.
Supervisory Responsibilities:
N/A
Location:
Onsite position - This role is 100% onsite with no remote option.
Travel:
N/A
Position Type and Expected Hours:
1st shift - Full Time - Monday to Friday: 8AM to 5PM.
It is the policy of SpiTrex 3D to provide equal employment opportunities (EEO). Also, the State of California is an equal opportunity employer to all, regardless of age, ancestry, association with a member of a protected class, bereavement leave, color, disability, exercising the right to family care and medical leave related to serious health condition of employee or family member, child bonding, or military exigencies, engaging in protected activity, gender identity or expression, genetic information or characteristic, marital status, medical condition, military and veteran status, national origin, pregnancy, childbirth, breastfeeding, or related medical conditions, Pregnancy Disability Leave (PDL), race, religious creed, reproductive health decision making, sex/gender, and sexual orientation. SpiTrex 3D expressly prohibits any form of workplace harassment. Improper interference with the ability of SpiTrex 3D employees to perform their job duties may result in discipline up to and including discharge. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training.
Other Duties:
Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.