Responsible for the development, maintenance, and implementation of specifications and standards for processes, materials, and products in accordance with quality programs, plans, SOPs and policies of the company’s Quality System and in compliance with FDA regulations, ISO 13485, and other regulatory requirements as applicable.
BS or MS degree in technical/scientific/engineering discipline, with at least 2+ years of experience in medical devices, in vitro diagnostics or a related industry. Experience developing and implementing quality plans and programs. ASQ certification (CQE, CRE) is preferred. Working knowledge and experience of FDA’s Quality System requirements (QSR), ISO 9001 and ISO 13485 standards. Ability to coordinate multiple project schedules and activities.
The candidate should have strong analytical, communication and interpersonal skills. Strong linguistic, grammar, and editing skills. Ability to multi-task in an environment with changing priorities. Strong statistical training, skills and experience.
Proficiency with Microsoft applications Word, Excel, Project, Visio, and PowerPoint. And ability to learn additional software applications, as the need arises.
Principal Duties and Responsibilities
- Assist in the development, implementation, and maintenance of Quality System specifications and requirements in accordance with cGMPs, ISO 13485 and other International regulations as applicable.
- Direct and/or participate in projects directed at the development and implementation of quality standards throughout the company.
- Participate in department meetings to provide input into the design and implementation of product specifications.
- Write, review and edit documents and SOPs as required.
- Assist during FDA inspections, ISO Certification and surveillance audits and customer and supplier audits.
- Assist in validation activities and development of requirements and specifications.
- Follow-up on corrective action responses, ensuring implementation of appropriate problem resolution methods and verifying effectiveness.
- Facilitates problem-solving activities, team building and quality systems tools and methodologies.
- Collaborate with other departments and functions on continuous improvement opportunities of the Quality System.
- Carry out other duties as required or assigned