Senior Quality Engineer - Manufacturing

SUMMARY DESCRIPTION

Provide Plant Quality compliance support for the following Quality tasks and duties:  Introduction and launching of new or improved products and processes into the Manufacturing Site.  Lead problem solving teams. Facilitate from a Quality & Quality Engineering and Plant perspective the launching of new or improved products/processes. Writing & coordinating efforts for the development and implementation of new and updated Quality System procedures for ISO/QSR, such as validation protocols, manufacturing procedures, product & material specifications, design & development documentation, SOPs, development and task force projects.  Facilitates the development, implementation and monitoring of quality programs and policies that ensure that the development, manufacture and distribution of medical products is in compliance with corporate policies, U.S. Food and Drug Administration regulations, ISO 9001, ISO 13485:2003, the Medical Device Directive, the Canadian Medical Device Regulations (CMDR), and other applicable regulatory agencies.

 

SUPERVISION RECEIVED - Under direct supervision of Director, Quality Assurance 

 

SUPERVISION EXERCISED - Supervisory responsibility for Manufacturing Quality Engineering Staff, and as a Project Leader

 

ESSENTIAL DUTIES AND RESPONSIBILITIESTo perform this job successfully, an individual must be able to perform each essential duty satisfactorily.

· Facilitate the launching of new or improved products/processes, and the transfer of technology from development to commercialization from a Quality and manufacturing perspective.

· Writing & coordinating efforts for the development and implementation of new and updated Quality System procedures for ISO/QSR, such as validation protocols, manufacturing procedures, product & material specifications, design & development documentation, SOPs, development and task force projects.

· Develop statistically based sampling plans for in-process and final testing and inspections, and validations.

· Work with project teams to develop DOEs and statistically sound tests for appropriate support of results.

· Develop, review and approve validations and completion reports for new and existing products, processes and equipment. Provide statistical analysis of the data to support the reports.

· Ensure that all projects are in compliance with GLP, QSR (including Design Controls), ISO or other applicable requirements.

· Formulate detailed product quality plans based on results of risk analysis

· Support as required the Quality Management Review Process

· Write and lead design validations

· Participate in FDA inspections, ISO Certification and surveillance audits and customer audits.

· Support corporate Regulatory Affairs by providing information for submissions and Annual Reports.

· Identify and implement opportunities for continuous improvement.

· Interact and coordinate activities with other departments, external vendors and customers.

· Work with Product Development team in order to ensure all aspects of Design Transfer activities are being met

· As required, assist or lead in the prompt implementation of Non-Conformance resolution, and Corrective & Preventative Action(s) (CAPA support)

· Develop and implement SPC control system with Manufacturing and Quality Control.

· Perform other Quality Systems related duties as required.

 DESIRED MINIMUM QUALIFICATIONS

The requirements listed below are representative of the knowledge, skill, and/or ability required for this position.

 

· Bachelors Degree in Engineering (Biomedical, mechanical, chemical, or electrical), Master’s degree preferred.

· 7 to 10 years experience in a Quality Assurance role for medical device or pharmaceutical manufacturing.

· Demonstrates excellent knowledge of statistical sampling and analysis, including DOE design.

· Demonstrates excellent math, organizational and communication skills, proficiency with MS Office Suite, and statistical software.

· Must be able to work independently with minimal supervision. 

· Must exhibit good working knowledge of statistics including coming up with statistical rationales for validations

· Able to perform and lead up risk analysis including FMEA’s

· Able to prioritize projects and manage Quality Engineering resources to meet organizational goals and objectives

· Able to mentor, train, and develop Junior staff.

· Able to lead projects of major complexity  TOOLS AND EQUIPMENT USED

· Knowledge of MS Office Suite

· Must be able to work with Minitab for statistical analysis