Quality Engineer

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!