All aspects of Quality System and Documentation Controls, within a Medical Device environment. Compliance with related Standards and regulations.
REPORTS TO: QA / RA Manager
Support the design, manufacture, and distribution of Skeletal Dynamics Strategic Manufacturing Center – Bonita Springs, FL Products and Services, while maintaining compliance with regulatory statutes and ISO 13485:2016. Supports quality system and document control initiatives.
KEY RESPONSIBILITIES AND AUTHORITIES:
- Performs responsibilities of document control, following all applicable internal procedures and external regulations. Proactively reviews relevant regulations to keep abreast of all applicable documentation standards, including FDA and ISO requirements. Reviews documents submitted through the Company’s document control system for proper format, accuracy, and completeness. Provides administrative support and record retention guidance/training to all documentation system users. Responsible for documenting department metrics, assignment of Quality System (QS) document numbers, and other document control tasks.
- Responsible for the management of Device History Records (DHRs) for product builds and WIP Quality Control. Revision / Creation of electronic files for Material Specifications, Engineering drawings, Inspection Plans, Labels, Quality Work Instructions (QWI’s) and other QS technical documentation. Also includes databases for nonconforming materials (NCR), the Corrective Action and Preventive Action (CAPA) system, Engineering Change Requests, and other QS documents. Compiles reports for QA as requested, and ensures applicable data is up-to-date and complete.
- Administers all QS SOP’s, Forms, Work Instructions, Engineering dwgs, and other documentation as required, to maintain regulatory compliance and to reflect changes to existing procedures. Interacts with other departments (e.g. Manufacturing, Operations) to develop procedures.
- Maintains the Approved Supplier List and monitors Supplier quality and performance.
- Performs other projects or Quality Engineering & Document Control tasks as assigned.
SECONDARY DUTIES AND RESPONSIBILITIES
- May perform or assist regulatory, quality systems, and engineering functions, as defined by quality system requirements to support current and new product (NPI) processes.
- May perform internal and Supplier quality audits.
- Responsible for data collection and KPI’s in support of Management Reviews
- QS training including Complaints, cGMP, cGDP, etc.
- 1-3 years Medical Device experience (Preferred)
- B.S. in Engineering or equivalent OTJ experiences
KNOWLEDGE & SKILLS:
- Experience in a highly regulated industry
- High attention to detail
- Proficiency in MS Office, including Word, Excel, PowerPoint and Adobe Acrobat.
- Highly adaptable to changing priorities
- Willingness to adapt to changes in job scope