Quality Engineer II

Quality Engineer - San Diego, CALocation: San Diego, CA – 92121 (Onsite)Project Duration: 5+ Months of contractShift Timing: 2nd shift (3:00 PM to 11:30 PM - Mon to Fri)Pay Rate: $45.00 per hour on W2Will be training on 1st shift for 2-3 months, so you will be receiving the pay rate as per 1st shift. Once you move to 2nd shift then you will be receiving 10% shift differential.Main Purpose of the Role:This position is responsible for developing and maintaining quality engineering methodologies and providing quality engineering support within new product development, manufacturing, or system/services support.Main Responsibilities: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 requirementsLead in the implementation of assurances, process controls, and CAPA systems designed to meet or exceed internal and external requirementsAssist in the development and execution of streamlined business systems which effectively identify and resolve quality issuesApply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issuesDesign and conduct experiments for process optimization and/or improvementAppropriately document experiment plans and results, including protocol writing and reportsLead process control and monitoring of CTQ parameters and specificationsLead 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-conformancesParticipate 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 analysisWork with design engineering in the completion of product verification and validationWork with microbiology to ensure appropriate environmental monitoring and that microbiology requirements are considered in product and process development activitiesSupport 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.Education:Bachelor's Degree in Engineering or Technical Field or equivalent experience (An equivalent combination of education and work experience)Master's Degree PreferredExperience/Background:Minimum 2 years 2-5 years Engineering experience and demonstrated use of Quality tools/methodologies.Detailed knowledge of FDA, GMP, ISO 13485, and ISO 14971Solid communication and interpersonal skills. Project management and leadership skills, including the demonstrated ability to lead multi-departmental project teams and resolve quality-related issues in a timely and effective manner.Advanced computer skills, including statistical/data analysis and report writing skills Prior medical device experience preferred. Experience implementing various product and process improvement methodologies (e.g., Six Sigma and Lean Manufacturing). ASQ CQE or other certifications preferred.Experience working in a broader enterprise/cross-division business unit model preferred. Ability to work in a highly matrixed and geographically diverse business environment. Ability to work within a team and as an individual contributor in a fast-paced, changing environment.Ability to leverage and/or engage others to accomplish projects.Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization. Multitasks, prioritizes and meets deadlines in timely manner.Strong organizational and follow-up skills, as well as attention to detail.About generis tek: generis tek is a boutique IT/professional staffing based in Chicago land. We offer both contingent labor & permanent placement services to several fortune 500 clients nationwide. Our philosophy is based on delivering long-term value and build lasting relationships with our clients, consultants and employees. Our fundamental success lies in understanding our clients' specific needs and working very closely with our consultants to create a right fit for both sides. We aspire to be our client has most trusted business partner. Generis Tek Inc