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.
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
· Develop PPAP Qualification Documentation per customer PPAP Requirements.
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)
· Using Problem Solving & Root-cause Analysis Tools:
o 5-why Analysis
o Fishbone Analysis
o Scheduling Brainstorm sessions
o 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.
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.
