Quality Engineer

Röchling Medical; City of Rochester (NY); On-site; USD 75,000 - 95,000; Full time

Benefits offered by this job

401(k)

401(k) matching

Health insurance

Health savings account

Life insurance

Paid time off

Vision insurance

Job summary

Röchling Medical Rochester is a leader in medical device manufacturing, seeking a Quality Engineer to lead quality initiatives and ensure compliance with regulatory, customer, and company requirements.

The role includes IQ/OQ/PQ submissions, validation, MSA, PFMEA, SPC, CAPAs, and cross-functional collaboration to improve product quality and manufacturing performance. BS degree with 5 years’ experience required; travel up to 10% may be needed.

Qualifications

• BS degree in Engineering, Quality, Manufacturing, or related technical discipline.
• 5 years of Quality Engineering experience in a regulated manufacturing environment.
• Strong understanding of FDA (21 CFR Part 820/QMSR) and ISO 13485 Quality System.
• Ability to travel as required to Suppliers, Customers, and other events. Up to 10%.

Responsibilities

• Lead quality engineering activities to ensure products, processes, and systems meet regulatory and customer requirements.
• IQ, OQ, PQ submissions and validation documentation.
• Develop and optimize inspection strategies, sampling plans, and test methods.
• Perform Data Analysis using Minitab; conduct capability analyses and risk documentation (PFMEA).
• Manage CAPAs, investigations, and supplier quality with SCAR process.
• Support audits and act as Internal Auditor; communicate metrics across functions.

Skills

FDA compliance

ISO 13485

Leadership

Analytical skills

Communication

Gage R&R / MSA

Statistical software

GD&T

Education

BS in Engineering, Quality, Manufacturing, or related technical discipline

Tools

Minitab

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