Engineer II, Quality Systems
26531 Ynez Road Temecula, CA 92591 US
- Identify and implement effective process control systems to support the development, qualification, and on-going manufacturing of products to meet or exceed internal and external requirements.
- Lead in the implementation of assurances, process controls, and CAPA systems designed to meet or exceed internal and external requirements.
- Assist in the development and execution of streamlined business systems which effectively identify and resolve quality issues.
- Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
- Design and conduct experiments for process optimization and/or improvement.
- Appropriately document experiment plans and results, including protocol writing and reports.
- Lead process control and monitoring of CTQ parameters and specifications.
- Lead and implement various product and process improvement methodologies (e.g., Six Sigma and Lean Manufacturing).
- Lead the investigation, resolution and prevention of product and process non-conformances.
- Participate in or lead teams in supporting quality disciplines, decisions, and practices (e.g., represent the Quality function as a Core Team Member).
- Lead in the completion and maintenance of risk analysis.
- Work with design engineering in the completion of product verification and validation.
- Work with microbiology to ensure appropriate environmental monitoring and that microbiology requirements are considered in product and process development activities.
- Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.
- Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments.
- Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.
- Performs other related duties and responsibilities, on occasion, as assigned.
Although this hasn't been an issue at The Planet Group, the staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at The Planet Group.