Bachelor's degree in Engineering, Quality, Manufacturing, or related technical discipline.
5 years of Quality Engineering experience in a regulated manufacturing environment.
Strong understanding of FDA (21 CFR Part 820/QMSR) and ISO 13485 Quality System.
Excellent verbal and written communication skills.
Proficient with statistical software and print reading skills including GD&T.
Responsibilities
Support Engineering Development and Validation activities including IQ, OQ, PQ submissions.
Develop Qualification Documentation such as Control Plans and PFMEA.
Investigate Product and Process Nonconformities using Root-cause Analysis Tools.
Support Audits as an Internal Auditor and Subject Matter Expert during external audits.
Develop and optimize inspection strategies and methods to ensure quality.
Benefits
Diverse health offerings including access to a health clinic.
Tailored training programs focused on continuous professional development.
Vending machines with a variety of snack and food options.
Mobile work options promoting flexibility.
Full Job Description
Your role
Support Engineering Development and Validation activities.
IQ, OQ, PQ Submissions
Document IQ, OQ, PQ Protocols
Document IQ, OQ, PQ Submissions
Software validation
Automated program validation
Measurement System Analysis (MSA) / Gage R&R / Measurement System Validation
Cleanroom validation
Perform Data Analysis using Minitab
Capability Analysis
ANOVA Studies
Develop Qualification Documentation
Develop Control Plans
Develop PFMEA and risk documentation
Develop Process Flow
Investigate Product and Process Nonconformities, Complaints, and CAPAs using Problem Solving & Root-cause Analysis Tools:
5-why Analysis
Fishbone Analysis
Scheduling Brainstorm sessions
Documenting Continuous Improvement Activities
Tracing production history throughout ERP, and other systems
Support Audits
Internal Auditor
Subject Matter Expert during external audits
Backroom support during audits
Perform supplier audits
Lead process audits
Monitor and analyze quality performance and present metrics
Develop and optimize inspection strategies and methods
Develop sampling plans
Select appropriate inspection methods & equipment
Gage design and development
Data collection strategies
Drive Quality and Improvement projects
Complete change orders
Review and submit supplier change requests/ notifications
Write and revise Forms, Work Instructions and SOP's
Train others on process changes
Work with suppliers to enhance the supply chain
Communicate and manage MRR - Material Rejection Reports to suppliers
Drive supplier improvement using the SCAR process
Evaluate and qualify new suppliers
Communicate directly with customers throughout
Project meetings
Quality issues
Required Skills/Abilities:
Excellent verbal and written communication skills.
Excellent interpersonal and customer service skills.
Excellent organizational skills and attention to detail.
Strong understanding of FDA (21 CFR Part 820/QMSR), and ISO 13485 Quality System
Strong analytical and problem-solving skills.
Strong leadership skills.
Ability to prioritize tasks and to delegate them when appropriate.
Ability to function well in a high-paced and at times stressful environment.
Ability to simplify complex situations and present them with an appropriate level of detail
Ability to analyze risk and make decisions
Proficient with statistical software
Proficient print reading skills including GD&T
Ability to travel as required to Suppliers, Customers, and other events. Up to 10%
Education and Experience:
Required
Bachelor's degree in Engineering, Quality, Manufacturing, or related technical discipline.
5 years of Quality Engineering experience in a regulated manufacturing environment.
Preferred
Medical device manufacturing experience.
Experience with injection molding and process validation.
Experience supporting ISO13485 audits.
ASQ Certified Quality Engineer (CQE).
Lean Six Sigma Green Belt or Black Belt certification.
Your benefits
Health Management: Your health and well-being are important to us. Take advantage of our diverse health offerings, such as the health clinic.
Training and Development: Our focus is on the continuous growth of our team members. We want to ensure that everyone can reach their full potential, which is why we offer tailored training programs for various roles. This helps you achieve peak performance and boosts your professional success!
Food: Our sites offer vending machines with a variety of snacks and food options for you to enjoy - perfect for added flexibility during shift work, ensuring convenient access to refreshments at any time.
Flexibility: Flexibility leads to efficiency - that's what we believe. That's why mobile work is possible.
