Quality Engineer

Primary Function

Leads submission efforts to the Customer for new and changed parts and processes. Resolves quality issues related to non-conformance, reports, customer complaints, and regulatory actions. Manages supplier quality issues and compliance for customers with regard to local and federal regulatory requirements.

Major Duties and Responsibilities

• Leads part approval process (PPAP) and ensures part quality throughout part development and production with customers and suppliers.
• Leads the resolution of customer and supplier quality issues related to non-conformance, reports, customer complaints, and regulatory actions. Acts as liaison with customer for all quality concerns.
• Designs, installs and evaluates quality assurance process sampling systems, procedures and statistical techniques.
• Compiles, reviews, and manages all customer and supplier regulatory data and submits to customer or third-party databases. (IMDS, BOM Check, Reach, RoHS, Conflict Minerals, etc.)
• Reviews technical data to ensure compliance to customer specific specifications.
• Develops, reviews and maintains process for material acceptance, inspection plans, and product drawings.
• Manages non-conforming process, evaluates effectiveness of corrective actions and participates in MRB (material review board).

Additional Responsibilities

• Assists in formulating quality assurance policies and procedures to ensure compliance with ISO 9001:2015 and ISO 13485:2016 Quality Management System (QMS). Acts as internal auditor as assigned.
• Assists in development, review and approval of process and equipment validation/qualifications and protocols. (IQ, OQ, PQ)
• Leads measurement feasibility review with Metrology and provides feedback to Customer.
• Conducts training on quality assurance concepts and tools.
• Works closely with internal departments to resolve in-house and supplier quality issues and supports the SQE to resolve supplier quality problems.

Required Skill/Knowledge:

Basic GD&T, blueprint reading, basic statistics, FMEA, problem solving, analytical skills, ability to lead a team, micrometer, calipers, MS Office, excellent verbal and written communication skills, highly organized, able to manage multiple priorities, collaborative nature. Ability to lead a team in solving complex problems. Able to make sound decisions under tight time constraints. Able to travel up to 20% of the time.

Preferred Skills/ Knowledge: (Ideal skill set)

IQMS, 1-3 years manufacturing experience, injection molding, medical, automotive, ISO, fishbone diagrams, 8D, A3, smart scope, CMM, internal auditing. Mini tab (6 pack, gauge R&R and DOE)

Education Level / Required Certification:

Bachelor's Degree in Engineering (Manufacturing, Mechanical, Industrial, Quality, Plastics, Process or Materials) with one semester of college Chemistry) or equivalent education and experience.

Additional Information:

Frequently required to reach with hands and arms, push, pull, stoop, kneel, crouch, climb, sit, walk, stand or balance. Must occasionally lift and/or move up to 35 pounds. Exposure to noise and odor of plastic. Requires use of personal protective equipment. Must have own transportation and valid driver’s license for travel between plants and occasionally travel to customers or suppliers. Other duties as required.