Description

The Manufacturing Total Quality Analyst supports and maintains the Quality Management System (QMS) to ensure compliance with company standards, customer requirements, and regulatory guidelines. This role is responsible for enforcing quality system requirements across manufacturing operations, holding processes, documentation, and production activities accountable to established standards. By actively monitoring compliance and addressing gaps on the production floor, this position helps prevent nonconformances and safeguard product quality and customer satisfaction.

KEY RESPONSIBILITIES
• Champion and uphold the company's values, mission, and quality policy in all activities.
• Adhere to company policies, procedures, and internal control standards.
• Ensure compliance with all applicable Quality Management System (QMS) requirements, including ISO 9001 and AS9100 as applicable to this role.
• Prepares and manages document control and quality system documentation, including trend data review, inspection procedures, work instructions or other applicable quality management requirements.
• Collects, analyzes, and reports quality data to identify trends and opportunities for process improvement.
• Establish control plans as part of product realization and process improvements.
• Lead root cause analysis and corrective/preventive action (CAPA) investigations for internal nonconformances, customer complaints and returned material.
• Monitors customer and employee feedback to evaluate the effectiveness of manufacturing-related business systems and processes
• Conduct internal audits and support external customer and third-party audits, addressing findings and driving closure of corrective actions.
• Partner cross-functionally with Engineering, Production, and Supply Chain teams to resolve quality issues, implement corrective actions, and verify effectiveness of process changes.

EDUCATION
• Bachelor's degree in Business, Quality, Mechanical or Industrial Engineering required.
• Prior experience in an AS9100 or ISO9001 manufacturing environment preferred.
• Minimum of 2-4 years of experience in a quality related role, preferably in the biomedical, automotive or aerospace industry required.

SKILLS & QUALIFICATIONS
• Strong verbal and written communication skills.
• Ability to independently organize and prioritize multiple tasks and duties.
• Proficient with Microsoft Office and/or ERP/production software. Propel experience a plus.
• Strong attention to detail and commitment to quality.
• Strong analytical and problem-solving skills.
• Working knowledge of quality system requirements under ISO 9001 and AS9100 as applicable to this role.
• Certified auditor experience is a plus.
• Preferred bilingualism in Spanish and/or Vietnamese.

TRAINING & COMPETENCY REQUIREMENTS
• Complete new-hire orientation and role-specific on-the-job training prior to performing unsupervised work.
• Complete Quality Management System (QMS) training applicable to this role, including quality policy awareness and the consequences of nonconformance to product or process requirements.
• Complete safety training applicable to this role.
• Maintain competency through periodic refresher or retraining as required by department procedures and applicable regulatory requirements.

WORK ENVIRONMENT
• Office setting. Controlled-temperature environment.
• Manufacturing floor environment. Exposure to moderate noise levels typical of a production floor.
• Occasional exposure to dust, fumes, or chemicals typical of a plastics manufacturing environment.

PHYSICAL REQUIREMENTS
• Prolonged periods sitting at a desk and working on a computer.
• Prolonged periods standing or walking on the production floor.
• Mobility to navigate the production floor to conduct inspections.
• Use of personal protective equipment (PPE) such as safety glasses while on production floor.

EXPECTED HOURS OF WORK
• This is a full-time salaried position, required to work Monday through Friday. Occasional weekend availability may be required based on business needs.

TRAVEL
• Up to 20% international travel required (Mexico).
• Travel may be required for training, customer visits, or supplier audits as business needs dictate.

Pay Range

$82,000.00 Annually to $103,000.00 Annually