Senior Quality Plant Engineer
Job Type : Fulltime/Salary
Assist in the maintenance and improvement of the Quality System to ensure the continued improvement of product quality. Has database knowledge and maintains the technical and non-technical documentation change system. Interprets and enforces all documentation formatting, standards, policies, and operating procedure requirements.
Coordinate at all levels of management in determining needs for insuring compliance of product which is compliant with Regulatory and Corporate Practices.
Ensure that product specifications applicable to are accurately translated into written procedural form and implemented in the manufacturer of products.
Coordinate with plant, corporate and customers for product complaints and resolution of product non-conformities.
Initiate & approve Changes to Processes, Materials, and Systems assuring compliance to quality and regulatory requirements.
Analyze and provide reports which demonstrate the performance of the Quality System to include reject and complaint trends, audit findings and corrections, and documentation errors.
Ensure that records are maintained and retained in accordance with established corporate policies and procedures.
Recommend or initiate personnel actions such as performance reviews and disciplinary measures.
Maintain good employee relations; enforce safety standards, good housekeeping and other Company rules and regulations.
Perform other duties typical to this position as assigned
Serve as the Deputy Quality Assurance Representative in the absence of the Quality Assurance Manager.
Assist in the coordination and performance of supplier audits as assigned by the Quality Assurance Manager.
Act as a back-up to the focus factory Quality Engineers for the release of product.
Bachelor’s Degree required
5-10 years of experience in a Quality Assurance function in an FDA environment preferred, ISO environment with CAPA experience required.
Requires a level of proficiency with word processing, spreadsheet, and database software.
Ability to communicate to all levels.
Must be quality conscious and people oriented.
Knowledge of personnel policies and human relations.
Good communication skills, both written and verbal. Demonstrated problem solving skills with technical issues, develop solutions, and successfully implement corrective action plans.