About TIDI Products…
TIDI Products is a market leading manufacturing of disposable infection prevention products and patient safety products, headquartered in Neenah, WI. We have manufacturing facilities in Neenah, WI, Arcadia, CA, Tijuana, MX and Changshu, CN and office space in Lake Forest, IL. TIDI provides best in class products and service to major healthcare products distributors and users worldwide.
We Support Care Givers and Protect Patients!!
The Quality Engineer role is the quality and technical liaison between engineering, internal and supplier manufacturing operations in support of the product life cycle. The Quality Engineer is accountable for supporting design transfer, design / process validation and helping to establish/track quality metrics.
ESSENTIAL DUTIES and RESPONSIBILITIES:
• Quality Engineer supports and defines the quality requirements to design and manufacturing engineering teams, including customer expectations, regulatory requirements, applicable voluntary standards and corporate requirements relative to product safety and efficacy.
• Review, assess and approve product design milestones, Design History Files and deliverables to ensure compliance throughout product development cycle.
• Provide support to CAPA Teams during containment, root cause investigation, plan development, and verification of effectiveness activities.
• Provides guidance about Six Sigma principles (Sampling, Acceptance Criteria, DOE, Statistical Process Control, Root Cause Analysis, FMEA, control charts, capability analysis)
• Perform analysis of reports and Statistical Process Control (SPC) data to identify trends and necessary corrective and preventive actions.
• Supports and provides guidance to Manufacturing Engineering during the process development, design transfer, and validation activities.
• Develops and implement standard methods for inspection, testing, and gage R&R, including the evaluation of validation requirements.
• Troubleshoot and direct the resolution of quality issues by fostering effective interdepartmental and cross-functional partnerships.
SUPPORT, ALIGN, ENABLE AND IMPROVE OUR CORE VALUES AND GUIDING PRINCIPLES:
• Understands internal and external customers
• Assure a safe work environment
• Encourage individual development
• Demonstrates teamwork and flexibility/adaptability
• Demonstrates honesty
• Keep our commitments
• Think systemically and ensure constancy of purpose
• Lead with humility and respect every individual
• Focus on process, embrace scientific thinking, flow and pull value, assure quality at the source and seek perfection
• Bachelor’s degree in an Engineering discipline or a related subject
• 5+ years relevant experience in a regulated manufacturing environment, preferably within the medical device industry.
• Process Validation experience highly preferred.
• CQE certification highly preferred.
• Working knowledge of FDA requirements associated with medical device design and manufacturing.
• Working knowledge of industrial quality engineering, six sigma techniques, and statistical analysis.
• Ability to establish cause and effect relationships, solve problems, apply scientific methods and optimize processes.
• Ability to problem solve and develop appropriate corrections and improvements.
• Must be able to communicate effectively, in writing and verbally, with people of various educational & technical backgrounds.
At TIDI Products we are committed to offering a comprehensive employee benefits program than help our employees stay healthy, feel secure and maintain a work/life balance.
TIDI Products is an Equal Opportunity Employer – Minorities/Females/Veterans/Disabled are encouraged to apply.