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 Systems Engineer will assist in the management and implementation of the Quality Management System to ensure compliance with ISO 13485 and the FDA’s Quality System Regulations 21 CFR Part 820 including CAPA, Complaint handling, Internal Audit and Product Release and distribution.

Essential Duties/Responsibilities:

· Leads the effective development, implementation and continuous improvement of the organizations’ quality assurance policies, assuring compliance with medical device standards (ISO 13485)

· Analyzes quality data and metrics to identify trends and areas for improvement.

· Create and maintain documentation related to quality processes, policies, reference procedures and work instructions in compliance with ISO 13485 and the FDA’s Quality System Regulations

· Supports internal, customer and regulatory audits as required.

· Trains internal staff on quality procedures and best practices.

· Supports eQMS implementation projects for CAPA, document and record control.

· Additional support for the Quality Management System activities as assigned.

Required Skills/Abilities:

· Working knowledge of ISO 13485, FDA 21 CFR Part 11/820 and ISO 14971 in medical device manufacturing.

· Proficient in quality tools and methodologies

· Knowledge of statistics in the context of medical device development and production.

· Excellent verbal and written communication skills, both technical and non-technical.

· Problem solving and analytical thinking skills to resolve challenges.

· Ability to function well in a high-paced and at times stressful environment.

Education and Experience:

· Bachelor's degree in engineering, quality assurance or a related field.

· 5+ years in quality assurance, preferably in the medical device industry

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!

Roechling Medical Rochester (RMR) is an Equal Opportunity Employer. RMR does not discriminate based on 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 based on qualifications, merit, and business needs.

Job Tags

Similar Jobs