Quality Engineer

Development Quality Engineer – Westford, MA Job Title: Development Quality Engineer Location: Westford, MA (100% ON‑SITE)

ID#: JP -46469

Pay Range: 50K – 70K / Annum The Sr. Development Quality Engineer will provide design quality expertise to a product development team, collaborating with cross‑functional members to ensure patient/user safety, customer satisfaction, and organizational success. Responsibilities: Lead or support on‑time completion of Design Control deliverables. Help establish objective, measurable, and verifiable product requirements. Support Design Verification and Validation planning & execution, including cross‑functional investigation & resolution activities. Lead Risk Management activities from product concept through commercialization. Support test method development and lead test method validation activities. Assist manufacturing process development & qualification for new product and design changes. Support component specification definitions, supplier sampling plan development, and vendor qualifications. Assist with biocompatibility and sterilization qualifications. Participate in audits and quality system improvement activities. Support company initiatives in Quality Management Systems (QMS), Environmental Management Systems (EMS), and regulatory requirements. Ensure compliance with client, U.S. FDA, EUMDR, and other applicable requirements. Maintain positive and cooperative communications with employees, customers, contractors, and suppliers at all levels. Basic Qualifications: Bachelor’s degree in Engineering or a Technical Field. Minimum 5 years of experience in R&D, Process/Manufacturing Engineering, and/or Quality with at least 2 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 with 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. Quality Engineer – Santa Clara, CA (Senior) Job Title: Quality Engineer (Senior) Location: Santa Clara, CA (100% ON‑SITE)

ID#: SEDAA 42840

Pay Range: 50K – 70K / Annum Position requires 2 Quality Engineers: Senior and Mid‑Level. The Senior role is 100% onsite with immediate start after screening. Key Responsibilities: Support Quality for software development, manufacturing, operations, and engineering teams. Review/approve SDLC documents. Lead Hazard Analysis activities. Assist with SOPs, Work Instructions, and occasional training. Occasionally write and execute test protocols and reports. Required Qualifications: Medical Device Quality experience (Ops or Manufacturing). Strong working knowledge of FDA/ISO regulations (13485, 14971, etc.). Ability to ramp up quickly. 3–5 years of experience. Quality Engineer – Santa Clara, CA (Mid‑Level) Job Title: Quality Engineer (Mid‑Level) Location: Santa Clara, CA (100% ON‑SITE)

ID#: SEDAA 42840

Pay Range: 50K – 70K / Annum This is a non‑exempt position with overtime paid at time and a half. It supports the Regulatory Affairs organization with compliance and audit readiness. Description / Summary: Drive preparation of KPI dashboards and maintain a pulse on formal RA management review and internal metrics. Manage strategic program for RA audit preparedness, anticipating risks, mitigating audit findings, and implementing preventive actions. Support quality system integration for acquisitions and new product introductions. Identify and implement systemic processes. Assist in tracking and maintaining regulatory post‑approval commitments. Lead quality system process improvement initiatives. Initiatives include: Establish audit support for integration products. Improve and maintain quality system procedures (e.g., change management). Liaise with cross‑functional partners and international affiliates to meet compliance needs. Participate in audit backrooms. Participate in RA projects. Tasks: Change management for procedural updates. Develop and implement an auditing plan for critical RA tasks. Manage CAPAs and auditing findings. Manage post‑approval commitments. Support QMS audits from an RA perspective. Support QMS integration tasks. Manage review metrics results. Skills: Independent and troubleshooting mindset. Critical thinker with problem resolution skills. Ability to drive a problem through resolution and implement mitigations. Capability to handle multiple streams simultaneously. Design Quality Technician – Hayward, CA Job Title: Design Quality Technician – (Color, Material, Finish) Location: Hayward, CA (100% ON‑SITE)

ID#: SEDAA

Pay Range: 45K – 70K / Annum Reports to the Design Quality Team Lead. Ensures visual and aesthetic quality of CMF (Color, Material, Finish) components meets design intent and quality standards. Responsibilities: Perform visual inspections of CMF parts to ensure compliance with specifications. 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 within 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 when applicable. Support root cause analysis and corrective action validation related to visual or CMF quality concerns. Qualifications (Must‑Have): Minimum 2 years in a manufacturing or quality environment (automotive preferred). Demonstrated experience in color discrimination and color harmony evaluation. Ability to compare color across multiple materials. Capability to lift up to 50 pounds. Strong attention to detail and visual accuracy. Experience with basic data entry and documentation using Google Docs, Google Sheets, and other digital tools. Excellent organizational skills and ability to manage multiple tasks with minimal supervision. Preferred Qualifications: Hands‑on experience using 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 working with cross‑functional teams including design, quality, and manufacturing. Previous experience in SAP and/or JIRA systems. Quality Engineer – Atlanta, GA Job Title: Quality Engineer Location: Atlanta, GA (100% ON‑SITE)

ID#: SEDAA 42448

Pay Range: 40K – 55K / Annum This non‑exempt position supports manufacturing and product development teams to ensure high‑quality product delivery and new product development. Main Responsibilities: Identify and control manufacturing process defects (scrap, nonconforming material, customer complaints) through root‑cause analysis and corrective/preventive actions. Query and analyze data to support complex release criteria documentation. Develop product quality plans, documents, and systems, including specifications and quality plans with product development teams. Create risk analyses and FMEAs. Develop process monitoring systems by identifying critical process steps and applying methods to reduce process variation. Lead process improvement efforts using quality metric data and appropriate analysis methods for product design and new product development. Create quality tools and training materials, identifying more effective tools and materials. Cultivate internal networks and develop an extensive external resource network. Lead moderate‑scope project teams. Provide guidance to less experienced staff and mentor lower‑level contributors. Plan, organize, and prioritize daily work to meet schedules. Exercise authority and judgment within defined limits. Manage impact of delays or errors on program schedules and resource allocation. Qualifications: Bachelor's degree required. Related work experience with a good understanding of the specified functional area. Technical knowledge and application of concepts, practices, and procedures. General understanding of business unit/group function within a quality system environment. Responsible for problems of moderate scope, requiring data analysis and judgment. Sr. Development Quality Engineer – Pleasanton, CA Job Title: Sr. Development Quality Engineer Location: Pleasanton, CA (ON‑SITE)

ID#: SEDAA 42740

Pay Range: 70K – 95K / Annum Full‑time, non‑exempt. Provides design quality expertise to a product development team, fostering collaboration to ensure patient/user safety, customer satisfaction, and organizational success. Responsibilities: Lead or support on‑time completion of Design Control deliverables. Support objective, measurable, and verifiable product requirements. Support Design Verification and Validation planning & execution, including cross‑functional investigation & resolution activities. Lead Risk Management activities from product concept through commercialization. Support test method development and lead test method validation activities. Assist manufacturing process development & qualification for new product and design changes. Support component specification definitions, supplier sampling plan development, and vendor qualifications. Assist with biocompatibility and sterilization qualifications. Participate in audits and quality system improvement activities. Support company initiatives in QMS, EMS, and regulatory requirements. Ensure compliance with Abbott, U.S. FDA, EUMDR, and other requirements. Maintain positive communication with employees, customers, contractors, and suppliers. Basic Qualifications: Bachelor’s degree in Engineering or a Technical Field. Minimum 5 years of experience in R&D, Process/Manufacturing Engineering, and/or Quality with at least 2 years supporting product development. Experience with medical devices and related regulations/standards. Experience in test method development and validation. Experience in preparing risk assessments, FMEA, and other risk documents. Preferred Qualifications: Advanced Degree in Engineering/Technical Field. Experience with active implantable medical devices. Knowledge of requirements management tools (e.g., DOORS) and use of JIRA. Working knowledge of statistics for verification and validation. Engineer, Research & Development – Minnetonka, MN Job Title: Engineer, Research & Development Location: Minnetonka, MN (ON‑SITE)

ID#: SEDAA 42525

Pay Range: 50K – 64K / Annum Qualifies professionals to lead medical device development projects with comprehensive project management and technical expertise, including budgets, schedules, risk registers, and regulatory compliance. Key Responsibilities: Contribute to design and development of medical devices, ensuring compliance with specifications and regulatory standards. Collaborate with engineering, quality, and regulatory teams for innovation and compliance throughout development. Participate and oversee product testing and validation activities. Prepare and maintain documentation for regulatory submissions and product lifecycle management. Test Technician – Irving, TX Job Title: Test Technician Location: Irving, TX (ON‑SITE)

ID#: SEDAA 42510

Pay Range: 30K – 34K / Annum Responsible for production of high‑quality medical device instruments, including detailed assembly and testing of electronic components. Works under general supervision and follows written procedures. Job Responsibilities: Perform testing of electronic components and assemblies using automated test equipment. May perform mechanical assembly of electromechanical subassemblies and devices. Read, comprehend, and follow written procedures; understand and follow verbal instructions, and may instruct others. Read and interpret engineering drawings, schematics, and complex test procedures. Participate in continuous improvement and quality initiatives to enhance production processes and metrics. Maintain accurate records for Device History Records and quality documents. Prioritize work by sequencing and timing based on precedence and importance. Represent the company positively during tours. Support Company initiatives in QMS, EMS, and regulatory requirements. Comply with FDA regulations, ISO, and other regulatory requirements, company policies, and procedures. Adhere to environmental, health, and safety SOPs and equipment policies. Maintain positive communication and collaboration across all levels. Minimum Qualifications: Experience with electronic assembly and test in medical device industry preferred. High School Diploma required; AAS preferred. 2+ years experience with electromechanical assemblies/electronic manufacturing. Preferred Qualifications: Experience troubleshooting equipment, building, and/or testing of electronic assemblies. Working knowledge of IPC standards and use of complex tools specific to functional areas. Experience in GMP, ISO, and FDA controlled environments. Ability to work within a team and as an individual contributor. Strong verbal and written communication skills at multiple levels. Ability to multitask, prioritize, and meet deadlines. Strong organization and follow‑up skills with attention to detail. Regular and predictable attendance, willingness to work overtime as required. Hand and lift up to 25 lbs. as needed. Ability to sit and stand for long periods; reach, stoop, kneel, crouch as needed. #J-18808-Ljbffr Sedaa Corporation