| A job at | Full time |
| Professional Level | |
| We are looking for | As of now |
| Division | Medical |
| Location | Rochester, NY |
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:
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
The Rochester location is Röchling Medical's center of excellence for the production of surgical forceps for minimally invasive electrosurgical devices and also offers a broad portfolio of plastic injection molded parts and value-added assembly work for the medical industry. With its technical expertise, the team in Rochester is able to support customers as a contract manufacturer for the entire product lifecycle from concept to complete approved medical device.
Röchling Medical is a preferred supplier and development partner to leading pharmaceutical, biotech and medical technology companies worldwide. At six locations in Germany, USA and China, we develop and manufacture tailor-made pharmaceutical packaging and administration solutions, consumables for medical diagnostics as well as sophisticated components and assemblies for medical devices under clean room conditions.
The Röchling Group has been shaping industry. Worldwide. For more than 200 years. We transform the lives of people every day with our customized plastics: they reduce the weight of cars, make medication packaging more secure and improve industrial applications. Our workforce of 11,737 people is located in the places where our customers are – in 92 locations in 25 countries.
Jeanne Covert
Personal
+1 585 254 2000 208
jcovert@roechling.com
Röchling Medical Rochester
Holleder Technology Park, 999 Ridgeway Ave.
14615 Rochester, NY
United States
