Manufacturing quality engineering

Quality Engineer IILocation: Newark, DEOnsite Flexibility: OnsiteContract DetailsPosition Type: ContractContract Duration: 12 monthsPay Rate: $55.00 / Hour (USD)Shift / Schedule: 2nd Shift, 2:00 PM – 10:30 PM; 1 Saturday expected per month (OT)Work Authorization: Applicants must be authorized to work for ANY employer in the U.S. We are unable to sponsor or take over sponsorship of an employment Visa at this time.Job SummaryDesigns, implements, and maintains quality assurance protocols and methods for processing materials into partially finished or finished products. 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. Designs methods and procedures for inspecting, testing, and evaluating the precision and accuracy of production processes, production equipment, and finished products. Performs analysis of reports and production data to identify trends and recommend updates or changes to quality standards and procedures when necessary. May ensure compliance to in-house and/or external specifications and standards (i.e., GLP, GMP, ISO, Six Sigma).Works on problems of moderate scope where analysis of situations or data requires a review of a variety of factors. Exercises judgment within defined procedures and practices to determine appropriate action. Builds productive internal/external working relationships.Developing professional expertise, applies company policies and procedures to resolve a variety of issues. Normally receives general instructions on routine work, detailed instructions on new projects or assignments.Key ResponsibilitiesThe incumbent may be asked to perform other function-related activities in addition to the below-mentioned responsibilities as reasonably required by business needs.Write & Execute TMV's and Simple Change Orders (Simple Procedure updates, no validations required, clarifications, etc.)Support Moderate to Complex Project Change Orders (validations, risk analysis updates, creation or major changes of SOP's/documents, etc.)Write & Execute PQ'sLead/Own CAPA'sSupport HRA's/HHE'sModel all quality values and coach others on BSH quality system requirements and standards to elevate the team's ability to produce high-quality products and implement best practices that emphasize defect prevention, reduction in variation and waste, and provide for continuous improvement.Provide quality engineering support to Operations, Engineering, and R&D in the design and manufacture of medical devices to ensure robust product builds and the production of high-quality products and manufacturing practices.Responsible for ensuring that the products produced meet applicable regulatory and quality standards and customer expectations.Develop and implement procedures, inspection procedures, and test methods in compliance with QMS, Medical Device Quality System Regulation, and Medical Device Directive requirements. Provides training as required.Act with urgency to identify and provide timely resolution to quality issues. Perform risk assessments and update risk management documentation as required.Perform customer complaint investigations, root cause investigations, root cause analysis, problem solving, and corrective actions.Review technical publications, articles, and abstracts to stay abreast of technical developments in the industry.Investigate and process Quality System Investigations (QSI) and Non-Conforming Events (NCE).Prepare reports assessing the suitability and effectiveness of assigned areas of the quality system.Actively participate in processes and meetings such as MRB, NCE, CAPA, and SCAR process.Review and approve routine to moderately complex ECO's, product-related change orders, engineering studies, sustaining engineering products, specifications, drawings, manufacturing procedures, design process verification, and validation documentation.Actively participate in facility and supplier audits and Notified Body and FDA inspections.Required SkillsExcellent computer skills including ability to use word processing, spreadsheet programs, and databasesExcellent ability to read, analyze, and interpret professional journals, technical procedures, and government regulationsExcellent technical writing skills with ability to write quality assurance reports and detailed proceduresGood presentation skillsGood interpersonal skills to interact with all levels of the company, sometimes in an adversarial roleKnowledge of GMP and GDP PrinciplesPreferred SkillsWorking knowledge of medical device Quality System Regulations (21CFR820), ISO 13485, and MDD requirements is beneficialKnowledge of microbiology, molecular biology, biochemistry, chemistry, and/or related disciplines is beneficialUnderstanding of nucleic acid amplification and detection technologies is beneficialUnderstanding of Scientific Method and statistical analysis is beneficialKnowledge of Oracle and Agile is beneficialCertified Quality Engineer is beneficialExperience in an FDA regulated industry is beneficialEducation RequirementsPreferred Minimum: Technical Bachelor's Degree1–2 years of experience with a Technical Bachelor's Degree; 0–2 years with a Master's DegreeRequired Experience1–2 years of experience with a Technical Bachelor's Degree, or 0–2 years with a Master's DegreeWork Environment / Physical RequirementsSit; use hands to finger, handle, or feel objects, tools, or controlsStand; walk; reach with hands and arms; and stoop, kneel, crouch, or crawlLifting/moving and carrying products weighing up to 40 poundsExposure to moving mechanical parts, vibration, and/or moderate noise levelsExposure to hazardous chemicals or other materialsSafety Shoes with Impact and Compression Protection must be worn in designated areasExposure to bloodAbility to work in a clean room, controlled environment, and/or dark roomExposure to high voltage electronics and radiationImportant NotesInterview Process: Initial 30-minute MS Teams call with Hiring Manager; 2nd Round Onsite Meeting with Hiring Manager & Skip LevelBenefitsMedical, Vision, and Dental Insurance Plans401k Retirement FundAbout the ClientThis client operates in the medical device manufacturing industry, designing and producing diagnostic and treatment technology — including women's health applications — for worldwide distribution from their Newark, DE facility. The organization functions within an FDA-regulated environment with rigorous GMP and GDP compliance requirements, and employs quality assurance engineers, manufacturing technicians, receiving inspectors, and related technical professionals who collaborate across operations, engineering, and R&D functions.About GTTGTT is a minority-owned staffing firm and a subsidiary of Chenega Corporation, a Native American-owned company in Alaska. We highly value diverse and inclusive workplaces and support Fortune 500 organizations across banking, financial services, technology, life sciences, biotech, utilities, and retail sectors throughout the U.S. and Canada.