Sr. Pre-Market Supplier Quality Engineer (CV CRHF)

Location: Mounds View, Minnesota, United States of America

Salary: USD 99,200–148,800 per year

Company

hirify.global develops healthcare technologies and medical devices for cardiac mapping, ablation, and other clinical applications.

What you will do

• Partner with Design, Reliability, Technical Sourcing, Component Engineering, and Quality teams to develop, qualify, and release supplier components and materials for new products.
• Identify, evaluate, approve, audit, and monitor suppliers while resolving complex supplier-related quality issues.
• Define component qualification strategies, qualification plans, acceptance criteria, control plans, and receiving inspection requirements.
• Analyze qualification and process capability data using Minitab and Excel, including statistical analysis and Gage R&R studies.
• Develop inspection tooling and test methods, validate internal test methods, and support supplier process and component development.
• Prepare quality agreements and documentation supporting supplier qualification, commercialization, GMP, ISO, and regulatory compliance.

Requirements

• Bachelor’s degree in Engineering, Science, or a technical field with 4+ years of Engineering and/or Quality experience, or an advanced degree with 2+ years of relevant experience.
• Unrestricted U.S. work authorization is required at hire and throughout employment; sponsorship is not available for this role.
• Experience with supplier controls, process validation, supplier and internal audits, failure investigations, statistical quality control, and nonconforming product controls.
• Knowledge of manufacturing and inspection processes, supplier qualification, and contract manufacturing.
• Working knowledge of statistics, DOE, Minitab, Microsoft Office, and quality problem-solving methods such as DMAIC, Kepner-Tregoe, and Fishbone.
• Knowledge of QSR 21 CFR 820, CMDR, EU MDD 93/42/EEC, and ISO 13485, with strong written, oral, and cross-functional communication skills.

Nice to have

• 2+ years of supplier quality engineering experience in the medical device industry or a related field.
• PPAP knowledge, ASQ CQE certification, or ASQ Lead Auditor certification.
• Experience with laser micrometers, optical measurement systems, tool scopes, injection molding, thermoforming, metal forming, or machining.
• Green Belt DRM or 6S experience.

Culture & Benefits

• Purpose-driven work focused on improving healthcare and patient outcomes.
• Regular employees may receive health, dental, vision, life, disability, and retirement benefits.
• Benefits include paid time off, paid holidays, tuition assistance, employee stock purchase options, and incentive plans.
• The position is eligible for the hirify.global Incentive Plan short-term incentive.