Job Description

Company Overview

Röchling Medical Rochester is a leader in the medical device manufacturing sector, part of The Röchling Group. With a strong focus on contract manufacturing, product design, and mold making, we deliver high-quality surgical, laboratory, and diagnostic devices through precise engineering and robust program management.

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.
• 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.

Roechling Medical Rochester 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

Pay: $75,000.00 - $95,000.00 per year

Benefits:

• 401(k)
• 401(k) matching
• Dental Insurance
• Health insurance
• Health savings account
• Life insurance
• Paid time off
• Tuition reimbursement
• Vision insurance

Compensation Package:

• Bonus opportunities

Schedule:

• 8 hour shift
• Day shift

Ability to Commute:

• Rochester, NY 14615 (Preferred)

If you are ready to make a significant impact in the medical device industry with your engineering expertise, we invite you to apply today to join our innovative team at Röchling Medical!

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