Quality Engineer II
Quality Engineer II
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Job Description
Responsibilities may include the following and other duties may be assigned.
- Conducts a compliant validation process for quality information technology systems which requires formal validation documentation (including standard operating procedures) under appropriate federal regulations.
- Coordinates activities with clients programmers/developers and operating personnel domestic and as appropriate global.
- Identifies current and anticipated requirements for compliant computerized operations and suggests methods for the identification implementation and maintenance of the procedures actions and documentation necessary to assure compliance according to the appropriate federal and international regulations which govern the users applications.
- Reports on the status of validation activities to fulfill regulatory requirements.
- Performs system administration and configuration of quality information technology systems.
- Performs investigation non-conformance events
- Knowledge of Good Manufacturing Practices
- Good oral and written communication skills (English and Spanish)
- Computer knowledge (Excel Word Power Point etc.)
- Availability to work overtime and weekends when necessary
- Good problem-solving skills
- Initiates recommends and provides solutions to the Non-Conforming Product as per procedures
- Verifies the implementation and effectiveness of non-conforming CAPA
- Executes job responsibilities as established in the procedures
- Follows the documentation procedures Non- Conformance Resolution
- Evaluating Investigating & Completion of Non- Conformance
- Investigation ( Data gathering of Quality issue)
- Identify Corrective/Preventive Actions
- Implementing Corrective/Preventive Actions
- Lead complaint activities with the Operating Units members
Nice to Have: Please add skills etc
Lean Six Sigma Green Belt Certification
Microsoft Office (Excel Word Outlook Power Point Project) Agile HR - ABRA Suite Maximo MRO Program SAP TEDS Agile Compliance Wire Gallup On-line Tool
Must Have: Minimum Requirements
- Bachelors degree in Engineering required. and minimum of 2 years of relevant experience or advanced degree with 0 years of experience.
- relevant experience
- Fully Bilingual
- Able to set effective priorities and implement decisions to achieve immediate goals
JOB DESCRIPTION
Responsibilities may include the following and other duties may be assigned. Develops modifies applies and maintains quality standards and protocol for processing materials into partially finished or finished materials product. Collaborates with engineering and manufacturing functions to ensure quality standards are in place. Devises and implements methods and procedures for inspecting testing and evaluating the precision and accuracy of products and production equipment. Designs or specifies inspection and testing mechanisms and equipment; conducts quality assurance tests; and performs statistical analysis to assess the cost of and determine the responsibility for products or materials that do not meet required standards and specifications. Ensures that corrective measures meet acceptable reliability standards and that documentation is compliant with requirements. May specialize in the areas of design incoming material production control product evaluation and reliability inventory control and/or research and development as they apply to product or process quality. SPECIALIST CAREER STREAM: Typically an individual contributor with responsibility in a professional discipline or specialty. Delivers and/or manages projects assigned and works with other stakeholders to achieve desired results. May act as a mentor to colleagues or may direct the work of other lower level professionals. The majority of time is spent delivering and overseeing the projects from design to implementation while and adhering to policies using specialized knowledge and skills normally acquired through advanced education (typically University). DIFFERENTIATING FACTORS Autonomy: Established and productive individual contributor. Works independently with general supervision on larger moderately complex projects / assignments. Organizational Impact: Sets objectives for own job area to meet the objectives of projects and assignments. Contributes to the completion of project milestones . May have some involvement in cross functional assignments. Innovation and Complexity: Problems and issues faced are general and may require understanding of broader set of issues or other job areas but typically are not complex . Makes adjustments or recommends enhancements in systems and processes to solve problems or improve effectiveness of job area. Communication and Influence: Communicates primarily and frequently with internal contacts . External interactions are less complex or problem solving in nature. Contacts others to share information status needs and issues in order to inform gain input and support decisionmaking. Leadership and Talent Management: May provide guidance and assistance to entry level professionals and / or employee in Support Career Stream. Required Knowledge and Experience: Requires practical knowledge and demonstrated competence within job area typically obtained through advanced education combined with experience. Requires a University Degree and minimum of 2 years of relevant experience or advanced degree with 0 years of experience.
**Weil Group is proud to be an Equal Employment Opportunity Employer.**Employment Type
Full Time
