Quality Engineer

Quality Engineer – Santa Clara, CA (100% ON‑SITE) Job Title: Quality Engineer Location: Santa Clara, CA (100% ON‑SITE)

ID: 42840

Pay Range: 50K–70K/Annum This role requires medical device quality experience and the ability to start contributing quickly. Training on Abbott systems will be provided. Key Responsibilities Support quality for software development, manufacturing, operations, and engineering teams. Review and approve SDLC documents. Lead hazard analysis activities. Assist with SOPs, work instructions, and occasional training. Occasionally write and execute test protocols and reports. Provide process/quality engineering support to manufacturing and product development teams. Identify and control manufacturing process defects. Develop product quality plans, documents, and systems. Support risk analyses, FMEAs, and process monitoring systems. Lead process improvement efforts and use quality metrics. Assist in the creation of quality tools and training materials. Serve as a mentor to less experienced staff. Prioritize work and maintain documentation for regulatory compliance. Qualifications Medical device quality experience (operations or manufacturing). Strong working knowledge of FDA and ISO regulations (e.g., 13485, 14971). Ability to ramp up quickly. 3–5 years of experience. Bachelor’s degree and knowledge of statistics or risk assessment tools preferred. Design Quality Technician – Hayward, CA (100% ON‑SITE) Job Title: Design Quality Technician – CMF (Color, Material, Finish) Pay Range: 45K–70K/Annum Description: The Design Quality Technician will ensure visual and aesthetic quality of CMF components meets design intent and defined quality standards. Responsibilities Perform visual inspections of CMF parts to ensure compliance with specifications and design intent. Evaluate color, texture, gloss, and material harmony across multiple materials. Identify, label, and organize CMF samples and parts for inspection and shipment. Support supplier quality by returning nonconforming samples and documenting findings. Maintain inspection records, images, and data using Google Sheets, Docs, and shared databases. Collaborate with Design, Manufacturing, and Supplier Quality teams to resolve appearance‑related issues. Use spectrophotometers or colorimeters to quantify color differences. Support root cause analysis and corrective action validation related to visual or CMF quality concerns. Qualifications (Must‑Have) Minimum two years’ experience in a manufacturing or quality environment (automotive preferred). Experience with color discrimination and color harmony evaluation. Ability to compare color across multiple materials. Physical ability to lift up to 50 pounds. Strong attention to detail and visual accuracy. Proficient with data entry using Google Docs and Sheets. Strong organizational skills and ability to manage multiple tasks with minimal supervision. Preferred Qualifications Hands‑on experience with spectrophotometers or colorimeters. Experience organizing and managing CMF sample libraries. Familiarity with automotive design quality or CMF processes. Goal‑oriented mindset with strong communication and teamwork skills. Experience with cross‑functional teams including design, quality, and manufacturing. Experience with SAP and/or JIRA. Quality Engineer – Atlanta, GA (100% ON‑SITE) Job Title: Quality Engineer Location: Atlanta, GA (100% ON‑SITE)

ID: 42448

Pay Range: 40K–55K/Annum Position is Non‑Exempt – overtime paid at Time and a Half. Key Responsibilities Identify and control manufacturing process defects (scrap, nonconforming material, customer complaints). Query and analyze data to support release criteria. Develop product quality plans and specifications. Create risk analyses and FMEAs. Develop process monitoring systems to reduce variation and defect causes. Lead process improvement initiatives and analyze quality metrics. Assist in creating quality tools and training materials. Cultivate internal and external networks for task completion. Lead moderate‑scope projects and guide less experienced staff. Prioritize daily work and exercise authority within defined limits. Manage project risks and adapt resources as needed. Qualifications Bachelor’s degree required. Experience in medical device quality and familiarity with FDA/ISO regulations. Ability to apply technical knowledge and identify root causes. Strong analytical and judgment skills for moderate‑scope problems. Sr. Development Quality Engineer – Pleasanton, CA (ON‑SITE) Job Title: Sr. Development Quality Engineer

ID: 42740

Pay Range: 70K–95K/Annum Responsibilities Lead and/or support on‑time completion of Design Control deliverables. Support establishment of objective, measurable, and verifiable product requirements. Support design verification and validation planning and execution. Lead risk management activities from product concept through commercialization. Support test method development and lead test method validation activities. Support manufacturing process development and qualification for new product and design changes. Support component specification definitions and supplier qualification plans. Support biocompatibility and sterilization qualifications. Support audits and quality system improvement activities. Support company initiatives related to QMS, EMS, and regulatory requirements. Comply with Abbott, FDA, EUMDR, and applicable regulations. Maintain positive collaboration with employees, customers, contractors, and suppliers. Basic Qualifications Bachelor’s degree in Engineering or Technical Field. Minimum five years’ experience in R&D, Process/Manufacturing Engineering, and/or Quality with at least two years supporting product development. Experience in medical devices and associated regulations/standards. Experience in test method development and validation. Experience preparing risk assessments, FMEA, and other risk documents. Preferred Qualifications Advanced degree in Engineering/Technical Field. Experience in active implantable medical devices. Knowledge of requirements management tools (e.g., DOORS) and use of problem reporting systems (e.g., JIRA). Working knowledge of statistics and its application to verification and validation. Engineer – Research & Development – Minnetonka, MN (ON‑SITE) Job Title: Engineer, Research & Development Location: Minnetonka, MN (ON‑SITE)

ID: 42525

Pay Range: 50K–64K/Annum Description A qualified professional to lead and support medical device development projects through comprehensive project management and technical expertise. Responsibilities Contribute to the design and development of medical devices, ensuring products meet specifications and regulatory standards. Develop and maintain detailed project plans, budgets, schedules, and risk registers. Facilitate effective interactions among cross‑functional teams and stakeholders. Support product testing and validation activities. Prepare and maintain documentation for regulatory submissions and product lifecycle management. Qualifications Experience leading medical device development projects. Strong communication and collaboration skills. Proficiency with project management tools and documentation. Test Technician – Irving, TX (ON‑SITE) Job Title: Test Technician Location: Irving, TX (ON‑SITE)

ID: 42510

Pay Range: 30K–34K/Annum Position is Non‑Exempt – overtime paid at Time and a Half. Responsibilities Perform testing of electronic components and assemblies using automated test equipment. May perform mechanical assembly of electromechanical subassemblies and devices. Read and interpret engineering drawings, schematics, and complex test procedures. Participate in continuous improvement and quality initiatives. Maintain accurate records for Device History Records and quality documents. Prioritize work by sequencing jobs based on precedence and importance. Represent the company positively during tours by demonstrating techniques. Support company initiatives related to QMS, EMS, and regulatory requirements. Comply with FDA, ISO, and company policies. Adhere to environmental, health, and safety SOPs and equipment policies. Maintain positive collaboration with employees, customers, contractors, and vendors. Minimum Qualifications High school diploma or equivalent required; AAS preferred. Two or more years’ experience with electromechanical assemblies and electronic manufacturing. Experience with electronic assembly and test in a medical device industry preferred. Preferred Qualifications Experience troubleshooting equipment and building/testing electronic assemblies. Knowledge of IPC standards and complex tools. Experience in GMP, ISO, and FDA controlled environments. Ability to work within a team and independently in a fast‑paced environment. Strong verbal and written communication skills. Excellent organizational and follow‑up skills. Ability to maintain regular attendance. Ability to work scheduled overtime. Capacity to lift up to 25 lbs and ability to sit/stand for long periods. Physical endurance for repetitive tasks. #J-18808-Ljbffr Sedaa Corporation