Medicalproduct manufacturer is seeking a Sr.Quality Engineer who will assist with identification of best practices forthe organization and demonstrate exceptional knowledge of FDA 21 CFR 820 andISO 13485. Work closely with engineeringregarding quality support for new and ongoing projects enabling rapidassimilation of customer specifications into manufacture-able product. Work aspart of a team providing CAPA leadership, maintaining improving companypolicies, procedures work standards, and manufacturing environments. Theposition reports to the Dr. QA/RA. Runway to Manager opportunity.
Essential Job Duties:
- Assist with the design and compilation of metrics for operation’s performance, post market surveillance and quality systems data.
- Develop programs for maintenance, replacement and improvement of inspection techniques, gage R and R and new electronic collection and data reduction techniques.
- Manage and support the environmental monitoring and controls.
- Manage customer related quality and regulatory inquiries.
- Coordinate CAPA and NCMR (non-conforming material) meetings, investigate root causes and develop plans for implementing corrective actions as necessary.
- Identify process problems and non-conformance’s in manufacturing processes and develop corrective actions.
- Support the Quality Assurance organization by collaborating on customer complaints to investigate root causes and implement corrective actions and respond to customers with written responses to complaints.
- Perform internal and external audit as required, including pre-audit preparation and assisting with post audit communication.
- Review procedures for accuracy and make updates using a Document Change Order to reflect process changes and develop production procedures, standard operating procedures and drawings.
- Direct improvements in Quality Assurance processes such as NCMR/MRB. Coordinate NCMR (non-conforming material) meetings and investigate root causes and develop plans for implementing corrective actions as necessary.
- Implement GMP (Good Manufacturing Practices) throughout the manufacturing organization. Coordinate the training of Manufacturing Supervisors and Assemblers and act as a mentor and technical resource.
- Identify Quality System training or retraining needs and develop and deliver appropriate training based on organizational priorities and training needs. Develop tools to evaluate training effectiveness as appropriate.
- Stay informed regarding the latest requirements regarding federal regulations and those of other governments applicable to company products.
- Participate on New Product Development teams to establish quality standards for new products and create process procedures, specifications and work instructions as needed and support new product launches.
- Mentor Quality staff and multiple discipline teams in problem solving and root cause techniques.