- Location
- Rochester, United States of America
- Department
- Engineering
- Seniority
- Senior
- Source
- Workday
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
Responsible lead for:
- Major quality system improvement projects, CAPA SME
- SME / Coach of specific Quality Processes (Document control, Change Control, Training, Validation)
- Major customer complaints
- Audit SME
Essential Duties/Responsibilities:
- Manage and Support 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
- Front and Back Room support during customer and process audits
- Perform supplier audits, support qualification of new suppliers
- Lead process audits
- Monitor and analyze quality performance and present metrics
- Drive Quality System improvement projects
- Write and revise Forms, Work Instructions and SOP’s
- Manage implementation and related change orders
- Train others on process changes
- Support Engineering Development and Validation activities.
- Process validation
- Software validation
- 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
- 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.
- 8 years of Quality Engineering experience in a regulated manufacturing environment.
Preferred
- ASQ Certified Quality Engineer (CQE).
- Lean Six Sigma 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.
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.