Engineer, Quality

Röchling Medical; Rochester (MN); Hybrid; USD 85,000 - 110,000; Full time

Job summary

Röchling Medical is seeking a Quality Engineer to support validation and quality assurance activities in a regulated manufacturing environment. You will contribute to IQ/OQ/PQ submissions, document protocols, and perform data analysis to drive improvements.

The role requires collaboration with suppliers and customers, and leadership in CAPAs and audits. You will develop control plans, PFMEA, and risk documentation, and use Minitab for capability analyses while navigating FDA/ISO requirements and

Qualifications

• Bachelor’s degree in Engineering, Quality, Manufacturing, or related technical discipline.
• 5 years of Quality Engineering experience in a regulated manufacturing environment.
• Familiarity with FDA 21 CFR Part 820/QMSR and ISO 13485 is required.
• Strong analytical and problem-solving skills with leadership ability.

Responsibilities

• Support IQ/OQ/PQ submissions and validation activities.
• Document IQ, OQ, PQ protocols and submissions.
• Perform data analysis and capability studies using Minitab (ANOVA, Capability Analysis).
• Develop control plans, PFMEA, and risk documentation.
• Lead internal and external quality audits and supplier audits.
• Drive quality improvements and implement inspection strategies.
• Train staff on process changes and SOP updates.
• Collaborate with suppliers and customers on quality issues and CAPAs.

Skills

Quality engineering

FDA/ISO knowledge

Statistical software

GD&T

Leadership

Risk analysis

Communication

Travel up to 10%

Education

Bachelor's degree in Engineering/Quality

Tools

Minitab

ERP systems

Job description

At Röchling Medical, we’re united by a shared purpose: improving lives through innovation in health. As a trusted partner to leading pharmaceutical, biotech, and medical device companies around the world, we develop customized products and solutions that help advance patient care and save lives.

Your role

• 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:

Required

• Bachelor’s 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.

Your benefits

• Health Management: Your health and well-being are important to us. Take advantage of our diverse health offerings, such as the health clinic.

• Training and Development: Our focus is on the continuous growth of our team members. We want to ensure that everyone can reach their full potential, which is why we offer tailored training programs for various roles. This helps you achieve peak performance and boosts your professional success!

• Food: Our sites offer vending machines with a variety of snacks and food options for you to enjoy - perfect for added flexibility during shift work, ensuring convenient access to refreshments at any time.

• Flexibility: Flexibility leads to efficiency – that’s what we believe. That’s why mobile work is possible.