Manufacturing Quality & CI Specialist

Summary/Purpose of the Position:

The Manufacturing Quality and Site Specialist will work closely with designated site personnel to become or maintain ISO 9001, AS9120, AS9100, ISO 14001, and/or ISO 13485 compliance. As business identifies additional certification needs, this role will supply compliance support as required.

As a Manufacturing Quality and Site Specialist you will develop, implement, maintain, improve, and support Quality Management System (QMS) and where applicable Environmental Management System (EMS) procedures and practices. This role is responsible for evaluating site compliance, Internal/External Audit preparation, and providing quality support for multiple locations.

Essential Duties, Functions and/or Responsibilities:

• Responsible for developing, implementing, and maintaining Quality and Environmental certification requirements
• Responsible for developing, implementing, and maintaining future certification requirements
• Responsible for preparation prior to Internal & External ISO and AS audits
• Develops action plans to address critical constraints as they are identified
• Identifies and implements “Best Practices”
• Functions as a customer/vendor liaison involving quality and environmental issues
• Supports QMS and EMS related information retrieval to ensure all needs are met for both internal and external customers
• Supports QMS and EMS related functions for management
• Serves as the primary contact for internal and external clients’ needing quality and environmental related information and/or documentation
• Responsible for completion and accuracy of customer driven requirements (i.e., PPAP, FAI, Validations, etc.)
• Manage Quality, Environmental, Health & Safety requirements
• Train and mentor personnel on QMS, EMS, and EHS requirements
• Analyze and implement QMS, EMS, and CI improvements and other duties as needed
• Maintain compliance related records for Zone REACH and RoHS programs
• Coordinates Management / Business Review meetings at applicable sites as required
• Directly and indirectly responsible for the quality of the product
• Other duties as assigned

Education and/or Work Experience Requirements:

• Bachelor’s degree in Engineering or Scientific field is preferred
• 5+ years of Quality experience preferred with 3+ years required (preferrable in AS9100,ISO 9001, ISO 13485)
• Bilingual English/Spanish – Written & Verbal is preferred
• Proficient in root cause and corrective action analysis
• Lean / Six Sigma is a plus
• Knowledge of technology applications relevant to records management environments AS9100 or AS9120 Aerospace Quality Programs, ISO 9001 Quality Programs, ISO 14001 Environmental Programs, ISO 13485 Medical Device and IATF 16949 Automotive programs
• Auditor certification preferred, or required to obtain auditor training in appropriate quality and environmental standards
• Certified Safety Professional preferred
• Lean Six Sigma certification preferred
• CQE or CQIA preferred
• Requires knowledge of regulated industry requirements
• Continuous Improvement and Statistical Process Control knowledge
• Foster innovation and improvements
• 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
• Willing to frequently travel (Mexico & USA)

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.

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.