Senior Quality Engineer (Medical Device)
As a key member of the Quality Assurance Team, the Senior Quality Engineer, Medical Device is to assume a lead role in providing Quality Engineering support for New Product Development projects. The Senior Quality Engineer is responsible for facilitating compliance to applicable internal and external requirements during the product development cycle and commercialization of new products.
Duties and Responsibilities:
Responsible for day-to-day administration of the QMS and in the development, implementation, and maintenance of QMS processes to meet the requirements of U.S. FDA (e.g. 21 CFR Part 820, Part 4), and other applicable quality and regulatory standards (e.g. ISO 13485, MDD, ISO 14971).
- Perform Design Control activities; ensure design control documentation and design change control requirements are met and appropriately traced throughout the development process and in the design history file.
- Drive the creation of an appropriate Risk Management Plan at the start of a project and maintain the plan through all phases of development; support risk assessment activities through AFMEA, DFMEA, PFMEA and other QA risk analysis techniques in order to manage potential risk during development and commercialization
- Support manufacturing site inspections/audits for compliance with Design Controls of Combination Products.
- Write and approve Quality Systems SOPs, Protocols and Reports to support all activities associated with Design Control
- Support various QMS activities including complaint handling, CAPA, internal and external audits, quality metric/dashboard development and maintenance.
- Identify quality improvement opportunities within areas of responsibility. Coordinate and participate in key quality initiatives, as appropriate.
- Provide analysis for Management Review (gathering metrics, creating charts and providing information)
- Provide strategic input to design development activities (Biocompatibility Testing, Packaging Testing, Sterilization Validation, Stability Testing, Statistical Sampling etc.)
- Must have working knowledge of CFR 820, CFR 4, ISO 13485, ISO 14971, and MDD
- Have working knowledge of sterilization, biocompatibility, and transit/shelf life standards a plus
- Have mechanical skills and have the ability to solve problems effectively
- Computer skills are needed, with experience using Microsoft Access, Word, Excel, PowerPoint, and Project
- Must have knowledge of statistics and application of statistical methods using Minitab, Jump, etc.
- Understand design, development, verification and validation processes
- Ability to listen effectively and utilize various modes to communicate with employees at all levels, suppliers, and potentially customers
- Be a collaborative team member and an advocate for product quality and compliance
- Demonstrate accuracy and thoroughness to improve and promote quality; apply feedback to improve performance; and monitor own work to ensure quality
Education and Experience:
- Bachelor's degree in engineering or related field or equivalent work experience required
- 5+ years of quality experience in a medical device or combination product required, including design controls, product/process validation, and technical problem solving
- CQA or CQE is a plus