Engineer, Quality

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

Essential Duties/Responsibilities:

• Support Engineering Development and Validation activities.
  • IQ, OQ, PQ Submissions
    • Document IQ, OQ, PQ Protocols
    • Document IQ, OQ, PQ Submissions
• Develop PPAP Qualification Documentation per customer PPAP Requirements.
  • Develop Control Plans
  • Develop PFMEA
  • Develop Process Flow
  • Perform Data Analysis using Minitab
  • Capability Analysis
  • ANOVA Studies
  • Measurement System Analysis (MSA)
• Using Problem Solving & Root-cause Analysis Tools:
  • 5-why Analysis
  • Fishbone Analysis
  • Scheduling Brainstorm sessions
  • Documenting Continuous Improvement Activities
• Internal Auditor
• Monitoring and analyzing quality performance

Required Skills/Abilities:

• Excellent verbal and written communication skills.
• Excellent interpersonal and customer service skills.
• Excellent organizational skills and attention to detail.
• 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.
• Proficient with Microsoft Office Suite and Minitab software.
• Proficient print reading skills

Education and Experience:

BS degree preferred.

At least 5 years’ related experience required.

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.

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.