JOB DESCRIPTION

Responsibilities may include the following and other duties may be assigned. Develops, modifies, applies and maintains quality standards. Collaborates with engineering and manufacturing functions to ensure quality standards are in place. Develop and implements methods and procedures for inspecting, testing and evaluating  products and production equipment. Performs statistical analysis. Ensures that documentation is compliant with requirements. May specialize in the areas of design, production control, product evaluation and reliability, as they apply to product or process quality. SPECIALIST CAREER STREAM: Typically an individual contributor with responsibility in a professional discipline or specialty. Delivers 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 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: Seasoned individual contributor. Works independently under limited supervision to determine and develop approach to solutions. Coaches and reviews the work of lower level specialists . Organizational Impact: May be responsible for entire projects or processes within job area. Contributes to the completion of work group objectives, through building relationships and consensus to reach agreements on assignments. Innovation and Complexity: Problems and issues faced are difficult, and may require understanding of multiple issues, job areas or specialties . Makes improvements of processes, systems or products to enhance performance of the job area. Analysis provided is indepth in nature and often provides recommendations on process improvements. Communication and Influence: Communicates with senior internal and external customers and vendors. Exchange information of facts, statuses, ideas and issues to achieve objective, and influence decisionmaking. Leadership and Talent Management: May provide guidance, coaching and training to other employees within job area.  Required Knowledge and Experience: Requires advanced knowledge of job area combining breadth and depth, typically obtained through advanced education combined with experience. May have practical knowledge of project management. Requires a University Degree and minimum of 2 years of relevant experience, or advanced degree with 1 years of experience.

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 user's 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
Bachelor’s degree in Engineer is required
relevant experience
Fully Bilingual
Able to set effective priorities and implement decisions to achieve immediate goals
 

**Weil Group is proud to be an Equal Employment Opportunity Employer.**