Senior Quality Engineer
Röchling Medical•Rochester, MN
•Hybrid
About The Position
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.
Requirements
- 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
- Bachelor’s degree in engineering, Quality, Manufacturing, or related technical discipline.
- 8 years of Quality Engineering experience in a regulated manufacturing environment.
Nice To Haves
- ASQ Certified Quality Engineer (CQE).
- Lean Six Sigma Black Belt certification.
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 and Quality issues
Benefits
- Health Management: health clinic
- Training and Development: tailored training programs
- Food: vending machines with a variety of snacks and food options
- Flexibility: mobile work is possible
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What This Job Offers
Job Type
Full-time
Career Level
Senior
