Responsible for planning, implementing and managing compliance of manufacturing and production processes with internal and external safety, quality and regulatory standards requirements for worldwide distribution
Participates in E&D design control processes related to design inputs and defines product/process inspection requirements for all current and new products. Develops Quality plans to include inspection drawings and specifications. Designs and/or purchases inspection equipment and fixtures as required.
Provides verification and validation expertise through IQ, OQ, and PQ protocol development and execution utilizing approved product and process validation SOP.
Develops quality inspection plans for internally manufactured and vendor supplied products, processes and components.
Assist in the development of internal reports to provide key quality operating measurement and trending for all Operations functions.
Leads and/or participates in company-wide Corrective and Preventive Actions projects.
Analyzes, justifies and recommends purchase of in house or vendor supplied inspection equipment.
Participates as team member on MRB related actions.
Assist in the inspection, investigation and documentation of product customer complaints.
Responsible for QE related DCR product and process change review and approval.
Direct or assist inspection training for QC inspectors and QE technicians.
Meet or exceed quarterly departmental goals and objectives.
Develop, monitor and provide timely feedback for quarterly goals and objectives.
Assist and support other team members as necessary.
Bachelors or better.
Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities
The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information. 41 CFR 60-1.35(c)