What are the responsibilities and job description for the Quality Engineer position at Röchling Medical?
Roechling Medical Rochester offers customers a wide range of high-quality, customized components and assemblies, right through to end-to-end OEM products. The product portfolio also includes standard plastic products, with special expertise in the fields of diagnostics, fluid management, pharma, surgery and interventional, and much more. These areas of competence are complemented by an enhanced range of services for development and regulatory affairs, right through to approval of end-to-end medical products.
Job Summary :
The Quality Engineer / Supplier QE is responsible for ensuring that products and processes meet established quality standards by identifying shortfalls, developing corrective measures, and implementing quality control systems, acceptance sampling, validations of injection molded, medical device and purchased components used in validated processes.
Essential Duties / Responsibilities :
- Support Engineering Development and Validation activities.
o IQ, OQ, PQ Submissions
Document IQ, OQ, PQ Protocols
Document IQ, OQ, PQ Submissions
o Develop Control Plans
o Develop PFMEA
o Develop Process Flow
o Perform Data Analysis using Minitab
o Capability Analysis
o ANOVA Studies
o Measurement System Analysis (MSA)
o 5-why Analysis
o Fishbone Analysis
o Scheduling Brainstorm sessions
o Documenting Continuous Improvement Activities
Required Skills / Abilities :
Education and Experience :
BS degree preferred.
At least 5 years’ related experience required.
Roechling Medical Rochester (RMR) 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