Plasma Surgical is the designer, manufacturer and distributor of surgical products used in over 20 countries.
The Regulatory Affairs and Quality Engineer is responsible for all quality systems within the Plasma Surgical organization and for managing compliance with all regulatory requirements in the territories in which the company and its products are manufactured and marketed. This position is also responsible for fulfilling the duties of the Management Representative.
Essential Job Functions:
Quality
- Implementation, maintenance, and ensuring compliance with the Quality Management System (QMS) throughout Plasma Surgical to ensure compliance with all relevant national and international standards including in particular ISO 13485 and the FDA Quality System Requirements set out in 21 CFR Part 820, as revised. This includes all elements of the QMS including but not limited to:
- Customer Complaints, investigations, communications as appropriate, and reporting
- NCR/CAPA, including root cause analysis, investigation, and implementation activities
- Supplier Management
- Training, conducting as appropriate, and related documentation
- Post Marketing
- Internal and External Auditing, including hosting, as appropriate
- Calibration, including management of Quality personnel as applicable
- Quality Control (QC), including management of Quality personnel as applicable
- Management Review
- Maintenance of all product technical files and corporate Quality System documents to ensure compliance with Federal US legislation and the Essential Requirements of the European Medical Devices Directive
- Collaboration with other departments to ensure that changes to literature and/or other external communications are compliant and consistent with indications for use
- Interact with all functional groups to drive the implementation of CAPA activities, to include effectivity measures such as root-cause analysis and change control
- Oversee via Document Control Management, the maintenance of all records of quality and regulatory compliance including the TrackWise document management system
- Ensures product safety, reliability and quality through the effective use of manufacturing quality planning, risk analysis, statistical methods and process controls. Develops and maintains statistically valid sampling plans for Quality Control inspection of incoming components, in-process sub-assemblies as well as functional testing and finished inspection of products
- Works within the Quality group to reduce reject (NCR) levels by timely identification and evaluation of issues from Goods receiving; In-process and all functional testing / Finished Product Release Inspections
- Coordinates with engineering and R&D regarding non-conformance investigations for components and in process materials/subassemblies. Acts as an integral partner with the manufacturing team to develop and execute strategies in support of manufacturing requirements and production output
- Creates/updates product design and technical documentation to support MDR and FDA 510(k) submissions and approvals
- Creates and supports software validation in compliance with IEC 62304.
Regulatory
· Registration of the Plasma Surgical group companies and products with regulatory bodies in each country in which the company operates and markets its products
· Preparation, filing and maintenance of files to obtain regulatory approval for the company’s products in each country in which the company markets its products; including FDA approvals in the USA
· Advise senior management on all quality and regulatory requirements pertaining to the companies’ products
· Advise research and development staff and sub-contractors on appropriate steps to be taken in the design of products to achieve compliance with national and international standards for product safety and regulatory compliance, and plans and coordinates validation and verification studies
· Advise marketing and clinical support staff on the regulatory requirements that apply to the clinical trials of the companies’ product
· Work closely with research and development to ensure that all products and applications are developed in compliance with design controls
Management Representative
Has authority over and accountability for:
· Ensuring that quality management system requirements are effectively established and maintained in accordance with Plasma Surgical policies and regulatory requirements
· Audit preparedness, presentation, hosting, and follow up activities in a timely manner
· Regular reporting on the performance of the quality system to senior management with responsibility for management review
Pay: From $85,000.00 per year depending on experience