RMS Medical Products, a publicly traded company based in Chester, NY, has the following career openings:
Manager of Quality Assurance
The Manager of Quality Assurance is responsible for all phases of product quality, from incoming materials to the finished product. in compliance with good manufacturing practices and FDA, ISO, and other international regulations.
Essential Duties & Responsibilities
- Involvement in the preparation of international submissions, CE Mark product dossiers and Technical Files/Design Dossiers, and additional international support
- Complete reviews of labels, literature and Web site for accuracy, consistency and regulatory compliance
- Develop and/or revise quality policies and procedures
- Prepare annual reports for PMA devices
- Review new product design protocols related to verification, validation, FMEA, etc.
- Process ECOs and CAPAs
- Develop QA sampling plans; create QA reports
- Develop equipment validation protocols
The requirements listed below are representative of the basic knowledge, skills, and/or abilities required. The candidate should be comfortable working in a smaller company environment and with all levels of employees.
- Bachelor's Degree, preferably in the physical sciences
- Five years direct experience in Quality Assurance within the Medical Device Industry (FDA and ISO 13485)
- Solid working knowledge of the regulatory requirements related to 21 CFR, Canadian and European medical device directives; additional experience with international registration requirements highly desirable
- Experience with (US) class I, II and III medical devices and (Europe) class I, IIa, IIb and III medical devices
- Capacity to communicate regulations to technical functions within the company
- Ability to manage relationships with FDA and international "customers" (e.g., regulatory agencies, distributors, etc.)
- Understanding of Gamma sterility processes
- Working knowledge of statistics
- Solid computer skills, especially with Microsoft Excel, and Microsoft Access and/or SQL
Please indicate general salary requirements with your response.
Medical Products Design Engineer
The Medical Products Design Engineer is responsible for product development, industrial design and plastics engineering projects for disposable and multi-use medical devices. As a member of a cross-functional team, this experience will span the entire development process, from concept development to reliable implementation.
- Support current products in terms of quality, manufacturing, supply continuity and cost improvement.
- Take product from concept to working model with a practical understanding of manufacturing.
- Provide innovative solutions concerning product design and development, and DFM (design for manufacture).
- Use sound judgment in selection of appropriate materials of construction.
- Lead activities related to test and evaluation of prototypes and finished medical devices.
- Work with Quality Management to ensure robust design through DOE and FMEA. Contribute to specification development.
- Coordinate internal and external design program resources.
- Ensure compliance with quality policies, procedures and practices as well as with all local, state, federal and company safety regulations, policies and procedures.
- Independently plan, implement, monitor and deliver designated tasks and deliverables to achieve project driven objectives.
Experience & Education
- 5 — 7 Years relevant work experience
- BS in Mechanical, Industrial, Process, Plastics or Biomedical Engineering or Industrial Design Degree
- Project planning experience
- Experience, and demonstrated proficiency, in the design of high-quality disposable and reusable medical devices.
- Proficient in Solidworks or ProE (Solidworks preferred), innovative problem solving, and plastics design engineering.
- Expertise in Design for Assembly and Design for Manufacturability
- Experience in plastic materials advantages and applications
- Knowledge of medical device design requirements, sterilization methods and its effect on materials and packaging methods
- Demonstrated experience with all phases of the Design Control process in the context of FDA and ISO 13485 regulations and understanding of disciplined product development processes, regulatory and quality requirements for medical products.
- Solid understanding of design verification and validation requirements management process, with demonstrated experience in strategy and implementation of these activities.
- A clear understanding of manufacturing process validation including FAI/FAT, development and IQ/OQ/PQ, with experience in the implementation of these activities.
- Ability to work independently as well as in a team oriented environment.
Candidates should also be creative, inquisitive, analytical, and detail oriented.
Effective communication skills (both orally and in writing) are required.
Strong technical judgment and problem solving skills are essential.
SPONSORSHIP IS NOT AVAILABLE FOR THIS POSITION
We are a leading manufacturer of medical products that are designed to save or improve the
quality of life. We are seeking people to fill key assembly positions. We offer a great working
environment, based on openness, trust and mutual accountability. No prior assembly
experience necessary for our assembler positions but good dexterity skills are required.
All positions offer opportunity for advancement. If you have the skills and are
seeking a challenging growth opportunity, please e-mail your cover letter, resume
and salary requirements to firstname.lastname@example.org or fax to 845-469-5518.
RMS offers a competitive salary and benefits package, including medical, dental, LTD and 401(k).