Overview

Quality Engineer Jobs in Rochester, New York Metropolitan Area at Röchling Medical

Title: Quality Engineer

Company: Röchling Medical

Location: Rochester, New York Metropolitan Area

Company Overview

Röchling Medical Rochester is a leader in the medical device manufacturing sector, part of The Röchling Group. With a strong focus on contract manufacturing, product design, and mold making, we deliver high-quality surgical, laboratory, and diagnostic devices through precise engineering and robust program management.

Job 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.

IQ, OQ, PQ Submissions

Document IQ, OQ, PQ Protocols

Document IQ, OQ, PQ Submission

Develop PPAP Qualification Documentation per customer PPAP Requirements.

Develop Control Plans

Develop PFMEA

Develop Process Flow

Perform Data Analysis using Minitab

Capability Analysis

ANOVA Studies

Measurement System Analysis (MSA)

Using Problem Solving & Root-cause Analysis Tools:

5-why Analysis

Fishbone Analysis

Scheduling Brainstorm sessions

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.

Job Type

Full-time

Pay range and compensation package

Pay: $75,000.00 – $95,000.00 per year

Benefits

401(k)

401(k) matching

Dental insurance

Employee assistance program

Health insurance

Health savings account

Life insurance

Paid time off

Referral program

Tuition reimbursement

Vision insurance

Schedule

8 hour shift, Day shift

Rochester, NY 14615: Relocate before starting work (Required)

In person

If you are ready to make a significant impact in the medical device industry with your engineering expertise, we invite you to apply today to join our innovative team at Röchling Medical!

Equal Opportunity Statement

Roechling Medical Rochester (RMR) is an Equal Opportunity Employer. RMR does not discriminate based on race, religion, color, sex, gender identity, sexual orientation, age, non-disqualifying physical or mental disability, national origin, veteran status or any other basis covered by appropriate law. All employment is decided based on qualifications, merit, and business needs.

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