Quality Engineer - South Bend
Essential Job Functions:

Essential Job Functions:

• Coordinate Measuring Machine Programming.
• Layout Inspection requirements using CMM equipment.
• Develop Process failure mode and effects (PFEMA) analysis
• Process / Product Control plan development and chart development
• Prepare Production Part Approval Process Documents for Submission to Customer.
• Administer Corrective & preventive actions and Vendor Corrective Actions
• Follow up CAPA Issuance, investigations, implementation and closure for suitability and effectiveness
• Create Quality Control Documentation.
• Perform Gage Reproducibility and Repeatability.
• Execute Design of Experiments for Optimizing Various Molding Processes.
• Implement Statistical Process Control on processes to attain up to 3-sigma capability on product dimensions.
• Investigate And Provide Objective Evidence Concerning Customer Requirements / Complaints.
• Utilizes appropriate problem-solving methodologies to determine root causes of quality problems and institutes measurable corrective actions.
• Participates in product quality planning activities to ensure the successful introduction of new products equipment and processes
• Provide Instructions for Gage Selection, Utilization and Training.
• Set and track quality assurance goals
• Leverages technical skills and innovation to meet customer requirements, enhance product functionality, improve aesthetics, and reduce manufacturing costs.
• Manages all aspects of multi-phased development projects, from inception through planning, prototyping and evaluation.
• Generates technical documents in accordance with ISO (9001 & 13485) requirements and internal procedures and design controls.
• Serves as technical support between Product Development, Business Development, Manufacturing Engineering, and Operations.
• Responsible for assessing product functionality.
• Assists and directs the efforts of technical personnel to complete client-driven requests for customer complaints.
• Supports manufacturing and production readiness activities as needed.
• Adheres to safety policies and strives to maintain our outstanding safety record
• Keeps work area, tools, supplies and equipment clean and organized.
• Performs other job-related and department-related duties as assigned

Experience, Knowledge, Skills and Abilities required:

• BS degree in related Engineering field or 3+ years of experience in quality engineering.
• 3+ years of demonstrated experience in a manufacturing environment.
• Experience in injection molding plastic industry is a plus.

• Demonstrated experience and knowledge of quality principles, ISO 13485, QMS, and statistical analysis.

• Experience with IQMS is a plus.

• Must have excellent attendance record.

• Great attention to detail and problem-solving abilities
• Ability to work safely and with minimal supervision.
• Ability to clearly communicate and interact with all levels of personnel professionally.
• Ability to adhere to workplace rules.
• Preferred but not required: candidate with hands-on engineering knowledge of plastic injection molding including part manufacturability, processing and tooling design.

Work Environment/Physical Requirements:

• Ability to stand for long periods of time
• Able to push, pull, lift, and carry up to 50 pounds
• Standing, walking, bending, reaching, kneeling.
• Possibility of exposure to noise, uncontrolled temperatures, and chemicals

Job Type: Full-time

Pay: $60,000.00 - $80,000.00 per year

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Health insurance
• Life insurance
• Paid time off
• Referral program
• Vision insurance

Schedule:

• 8 hour shift
• Monday to Friday
• Weekend availability

Ability to commute/relocate:

• South Bend, IN 95742: Reliably commute or planning to relocate before starting work (Required)

Work Location: One location

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