Quality Engineer

Summary/Purpose of the position:

Quality Engineers are responsible for managing quality management systems (QMS) at a manufacturing site as the designated site Quality Representative. The Quality Engineer will work closely with personnel to ensure compliance with applicable ISO 9001, AS9120, AS9100, and/or ISO 13485 international standards and customer requirements. As business identifies additional certification needs, this role will supply compliance support as required.

As a Quality Engineer, you will work with a cross-functional team to develop, implement, maintain, improve, and support Quality Management System (QMS) procedures and practices and the liaison for customers and vendors requiring quality support. This role is responsible for evaluating site compliance, preparation and hosting of internal/external audits, and providing quality guidance and support for multiple departments and locations.

Essential Duties, Functions and/or Responsibilities:

• Site daily oversite of the QMS and its corresponding elements for the designated site
• Responsible for developing, implementing, and maintaining QMS certification requirements
• Responsible for assisting in the development, implementation, and maintenance of future certification requirements or improvements to existing processes / certifications
• Customer/Supplier liaison involving quality issues
• Responsible for preparation and hosting Internal & External audits
• Responsible for completion and accuracy of customer driven requirements (i.e., PPAP, FAI, Validations, etc.)
• Identify and evaluate risks and opportunities throughout the organization
• Develops action plans to address critical constraints as they are identified
• Identifies and implements “Best Practices”
• Train and mentor personnel on QMS requirements
• Analyze and implement improvements and other duties as needed
• Directly and indirectly responsible for the quality of the product
• Supervisory duties of site Quality Technicians
• Other duties as assigned

education and/or Work experience Requirements:

• Bachelor’s degree in Engineering or Scientific field, is preferred
• Quality experience, 5 years preferred, 3 years required (preferable in AS9100, ISO 9001, or ISO 13485)
• Auditor training certification is a plus
• Bilingual English/Spanish – Written & Verbal, is preferred
• Proficient in root cause and corrective action analysis
• Requires knowledge of regulated industry requirements
• Continuous Improvement and Statistical Process Control knowledge
• Foster innovation and improvements, strong problem-solving skills
• Detail orientated, resourceful, analytical, and inquisitive
• Project Management skills
• Strong analytical and organizational ability
• Able to build collaborative relationships
• Self-motivated; able to work with minimal supervision
• Proficient in MS Office: Outlook, Word, Excel, Adobe acrobat, PowerPoint
• Good interpersonal and customer relations skills
• Attentive urgency and excellent follow-through required
• Ability to work independently and as a contributing team member

Physical Requirements:

• Ability to safely and successfully perform essential job functions in accordance with the ADA, FMLA, and other federal, state, and local standards, including meeting qualitative and/or quantitative productivity standards.
• Ability to maintain regular and timely attendance in accordance with the ADA, FMLA, and other federal, state, and local regulations.
• Ability to lift and/or carry up to 50 lbs. when necessary.
• Ability to move storage boxes weighing up to 20 lbs. when necessary.

This position requires applicants to be authorized to work in the US without sponsorship; TestEquity does not sponsor applicants for work visas.

TestEquity provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws.

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.