About this opportunity
Röchling Medical lists this Quality Engineer opportunity in city of rochester, New York. Review the employer’s description below for duties, qualifications and application requirements.
Job description
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.
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
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
Tracing production history throughout ERP, and other systems
Support Audits
Internal Auditor
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
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
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.
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.
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
401(k)
401(k) matching
Health insurance
Health savings account
Life insurance
Paid time off
Vision insurance
Compensation Package:
Bonus opportunities
Schedule:
8 hour shift
Day shift
Ability to Commute
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Who can apply
Review the original listing for work authorization, qualifications and employer requirements.