Quality Engineer

Röchling Medical · Rochester

FULL TIME$75,000 – $75,000 / yr

Job Description

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 is responsible for leading quality engineering activities that ensure products, manufacturing processes, and quality systems meet all applicable regulatory, customer, and company requirements. This role provides technical leadership for quality initiatives, supports new product development and validation, drives continuous improvement efforts, and partners cross-functionally to improve product quality and manufacturing performance.

Essential Duties/Responsibilities

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

BS 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.

Physical Requirements

Prolonged periods of sitting at a desk and working on a computer.

Must be able to lift up to 15 pounds at times.

Visual acuity for inspections, color differentiation, reading electronic documentation.

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.

Roechling Medical Rochester is an Equal Opportunity Employer. RMR does not discriminate on the basis of 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 on the basis of qualifications, merit, and business need.

Job Type: Full-time

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

Benefits

401(k)

401(k) matching

Dental Insurance

Health insurance

Health savings account

Life insurance

Paid time off

Tuition reimbursement

Vision insurance

Compensation Package

Bonus opportunities

Schedule

8 hour shift

Day shift

Ability to Commute

Rochester, NY 14615 (Preferred)

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!

Company	Röchling Medical
Location	Rochester
Type	FULL TIME
Niche	Full-time
Salary	$75,000 – $75,000 / yr

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