Quality Engineer/Supplier QE

Company Overview

Röchling Medical Rochester is a leader in the medical manufacturing industry, part of The Röchling Group. Our mission is to deliver world-class quality and precision in surgical, laboratory, and diagnostic devices through expert contract manufacturing and engineering.
Summary

The Quality Engineer/Supplier QE is responsible for ensuring that products and processes meet established quality standards by identifying shortfalls, developing corrective measures, and implementing quality control systems, acceptance sampling, validations of injection molded, medical device and, purchased components used in validated processes.

Essential Duties/Responsibilities:

· Support Engineering Development and Validation activities.

o IQ, OQ, PQ Submissions

§ Document IQ, OQ, PQ Protocols

§ Document IQ, OQ, PQ Submissions

· Develop PPAP Qualification Documentation per customer PPAP Requirements.

o Develop Control Plans

o Develop PFMEA

o Develop Process Flow

o Perform Data Analysis using Minitab

o Capability Analysis

o ANOVA Studies

o Measurement System Analysis (MSA)

· Using Problem Solving & Root-cause Analysis Tools:

o 5-why Analysis

o Fishbone Analysis

o Scheduling Brainstorm sessions

o Documenting Continuous Improvement Activities

· Internal Auditor

· Monitoring and analyzing quality performance

Required Skills/Abilities:

· Excellent verbal and written communication skills.

· Excellent interpersonal and customer service skills.

· Excellent organizational skills and attention to detail.

· 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.

· Proficient with Microsoft Office Suite and Minitab software.

· Proficient print reading skills

Education and Experience:

BS degree preferred.

At least 5 years’ related experience required.

Work Environment:

Manufacturing environment requiring appropriate eye protection.

Exposure to high noise level in the work environment requiring hearing protection.

Gowning and sanitation for manufacturing in a clean room, as applicable.

Job Type: Full-time

Pay: $75,000.00 - $95,000.00 per year

Benefits:

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

Work Location: In person