Quality Engineer
7 years ago
Santa Clara
Job Description:\n\n* LOCAL CANDIDATES TO WORK LOCATION (Santa Clara, CA) OR OPEN TO RELOCATE NO C2C* Job Title: Quality Engineer Location: Santa Clara, CA (100% ON-SITE) ID# SEDAA __42840 PAY RANGE: 50K - 70K/Annum The need is for 2 Quality Engineers. One more Senior and one Mid‑Level. Description: 100 percent onsite. Selected Candidates will start ASAP after screenings have cleared.St. Paul : 1225 Old Highway 8 NW 100 percent onsitMust come with Medical Device Quality experience and be able to start contributing quickly. Training will be provided on Abbott systems, but foundational medical device knowledge is required. Key ResponsibilitiesSupport Quality for software development, manufacturing, operations, and engineering teamsReview/approve SDLC documentsLead Hazard Analysis activitiesAssist with SOPs, Work Instructions, and occasional trainingOccasionally write/execute test protocols and reports Required QualificationsMedical Device Quality experience (Ops or Manufacturing)Strong working knowledge of FDA/ISO regulations (13485, 14971, etc.)Ability to ramp up quickly3–5 years experience * LOCAL CANDIDATES TO WORK LOCATION (Santa Clara, CA) OR OPEN TO RELOCATE NO C2C* Job Title: Quality Engineer Location: Santa Clara, CA (100% ON-SITE) ID# SEDAA __42840 PAY RANGE: 50K - 70K/Annum Description: This position is Non-Exempt. Hours over 40 will be paid at Time and a Half. Contingent Worker Regulatory Operations Description / Summary: This role will provide compliance support to the Regulatory Affairs organization by –a. Driving preparation of KPI dashboards and maintaining a pulse on formal RA management review and internal metrics.b. Managing strategic program for RA audit preparedness including anticipatory identification of risks, mitigation of risks identified during the audit process, and preventive actions for risks.c. Supporting quality system integration for acquisitions and new product introductions.d. Identifying and implementing system and/or systemic processes.e. Supporting tracking and maintenance of regulatory post-approval commitments.f. Driving quality system process improvement initiatives. Initiatives include but are not limited to:1. Establishing audit support for integration products.2. Improving and Maintaining the quality system procedures (e.g., change management)3. Liaising with cross-functional partners and international affiliates to meet compliance needs and driving to implementation/resolution.4. Participating in audit backrooms, and5. Participating in RA projects. Role has a potential for investigating nonconformances (CAPAs) and implementing mitigations. Exposure to Medical Device US and CE regulations, Quality Systems, a Quality role, or a Compliance role is a plus. List of tasks: Change management (change orders for procedural updates) Develop and implement an “auditing plan” for critical RA tasks (e.g., mock audits for Technical Files/Technical Documentations, Impact Assessments, Archival) as part of audit risk mitigation activities. CAPAs/Auding Finding management. Post-Approval Commitments management Support QMS audits from an RA perspective Support QMS Integration tasks Management Review Metrics results Skills: Independent Troubleshooting Critical thinker Ability to drive a problem through resolution and implement mitigations. Ability to handle multiple streams simultaneously. * LOCAL CANDIDATES TO WORK LOCATION (Hayward, CA )OR OPEN TO RELOCATE NO C2C* Job Title: Design Quality Technician Location: Hayward, CA (100% ON-SITE) ID# SEDAA __ PAY RANGE: 45K - 70K/Annum Description: Job Title: Design Quality Technician – (Color, Material, Finish) The Design Quality Technician – CMF will report to the Design Quality Team Lead and will be responsible for ensuring the visual and aesthetic quality of CMF (Color, Material, Finish) components meets design intent and defined quality standards. This role plays a key part in maintaining the highest quality standards for interior and exterior appearance parts through inspection, documentation, and continuous improvement activities. The technician will support the Design Quality and receiving organization by performing detailed color and material inspections, verifying visual harmony across components, and coordinating with suppliers and cross-functional teams to resolve quality issues and uphold brand standards. In this role, you will: Perform visual inspections of CMF parts to ensure compliance with specifications and design intent.Evaluate color, texture, gloss, and material harmony across multiple materials and components.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.Utilize tools such as 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 of experience in a manufacturing or quality environment (automotive industry preferred).Demonstrated experience in color discrimination and color harmony evaluation. Ability to evaluate and compare color across multiple materials (plastic, metal, fabric, paint, etc.).Ability 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 the 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 system * LOCAL CANDIDATES TO WORK LOCATION (Atlanta, GA )OR OPEN TO RELOCATE NO C2C* Job Title: Quality Engineer Location: Atlanta, GA (100% ON-SITE) ID# SEDAA 42448 PAY RANGE: 40K - 55K/Annum Description: This position is Non- Exempt. Hours over 40 will be paid at Time and a Half. Provide Process/Quality Engineering support to manufacturing, helping to ensure delivery of highest quality product to the customer. Provide Process/Quality Engineering support to product development teams, helping to ensure development of highest quality new products. MAIN RESPONSIBILITIESIdentifies and controls Manufacturing process defects (scrap, nonconforming material, customer complaints) by participating in efforts/teams focused on identifying the primary root causes and implementing corrective and preventative actions.May be responsible for querying & bounding data to support implementation of complex & documenting release criteria.Develops product quality plans, documents and systems by creating product specifications, quality specifications and quality plans in conjunction with other product development team members.May be responsible for creating risk analyses and FMEAs.Develops Process Monitoring Systems by identifying critical process steps applying methods to reduce process variation in order to reduce/eliminate the cause of defects.Leads process improvement efforts by identifying methods to capture quality metric data and by performing appropriate analysis methods to enhance sustaining product design and new product development.Assists in creation of Quality Tools & Training Materials by understanding the limitations of existing quality tools and training materials, and by helping to identify more effective tools & materials.Cultivates a wide range of internal networks and begins to develop an extensive external network of resources to facilitate completion of tasks.May lead a project team of moderate scope.Provides guidance to less experienced staff.Acts as a mentor to lower level individual contributors.Influence exerted at peer level and occasionally at first levels of management.Plans, organizes, and prioritizes own daily work routine to meet established schedule.Exercises authority and judgment within defined limits to determine appropriate action.Failure to achieve results or erroneous decisions or recommendations may cause delays in program schedules and mayresult in the allocation of additional resources. QUALIFICATIONSBachelor's requiredRelated work experience with a good understanding of specified functional area.Working technical knowledge and application of concepts, practices and procedures.General understanding of business unit/group function. Will perform this job in a quality system environment. Failure to adequately perform tasks can result in noncompliance with governmental regulations. Works on problems of moderate scope where analysis of situations or data requires a review of identifiable factors. Exercises judgment within defined procedures and practices to determine appropriate action. Has a broad knowledge of technical alternatives and an understanding of their impact on the systems environment. * LOCAL CANDIDATES TO PLEASANTON, CA OR OPEN TO RELOCATE NO C2C* Job Title: Sr. Development Quality Engineer Location: Pleasanton, CA (ON-SITE) ID# SEDAA 42740PAY RANGE: 70K - 95K/Annum Description: The Sr. Development Quality Engineer will serve as a technical representative providing design quality expertise to a product development team. Responsible for maintaining a strong collaborative partnership with cross-functional team members to achieve patient/user safety, customer satisfaction, and organizational success. RESPONSIBILITIES:Lead and/or support on-time completion of Design Control deliverablesSupport the establishment of objective, measurable, and verifiable product requirementsSupport Design Verification and Validation planning & execution, including any cross-functional investigation & resolution activitiesLead Risk Management activities from product concept through commercializationSupport test method development and lead test method validation activitiesSupport manufacturing process development & qualification for new product and design changesSupport the establishment of component specification definitions, supplied component sampling plan development, and vendor qualificationsSupport biocompatibility and sterilization qualificationsSupport audits and quality system improvement activitiesSupport Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and regulatory requirements.Comply with Abbott, U.S. FDA, EUMDR and other requirements, as applicable.Maintain positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and suppliers. Basic Qualifications:Bachelor’s degree in Engineering or Technical Field.Minimum of 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 validationExperience in preparing risk assessments, FMEA and other risk documents. Preferred Qualifications:Advanced Degree in Engineering/Technical FieldExperience 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? * LOCAL CANDIDATES TO MINNETONKA, MN OR OPEN TO RELOCATE NO C2C* Job Title: Engineer, Research & Development Location: Minnetonka, MN (ON-SITE) ID# SEDAA 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. This role involves developing and maintaining detailed project plans, budgets, schedules, and risk registers to ensure successful execution and alignment with organizational goals.The candidate will contribute to the design and development of medical devices, ensuring that all products meet defined specifications and comply with applicable regulatory standards. Collaboration with engineering, quality, and regulatory teams will be essential to drive innovation and maintain compliance throughout the development process.Strong communication and collaboration skills are critical, as this role requires facilitating effective interactions among cross-functional teams and stakeholders. The ability to foster alignment and transparency across departments will be key to project success.In addition, the candidate will participate in and oversee product testing and validation activities to ensure that devices meet performance, safety, and quality requirements. Coordination with relevant teams will be necessary to support verification and validation efforts.Finally, the role includes preparing and maintaining documentation to support regulatory submissions and product lifecycle management. All documentation must be accurate, complete, and compliant with industry standards and internal policies. * LOCAL CANDIDATES TO ST. PAUL, MN OR OPEN TO RELOCATE NO C2C*** Job Title: Test Technician Location: Irving, TX (ON-SITE) ID# SEDAA 42510 Training Days 8:45 to 3:30 Monday 7:00 to 3:30 Tuesday 6:00am to 2:30 next 8 days PAY RANGE: 30K - 34K/Annum Description: Job Summary: Working under general supervision, this position is responsible for the production of high-quality medical device instruments. This position includes detailed assembly and testing of various electronic components and finished devices in a controlled manufacturing environment. Job Responsibilities:Performs testing of electronic components and assemblies using automated test equipmentMay perform mechanical assembly of electromechanical subassemblies and devicesAbility to read, comprehend and follow written procedures; understand and follow verbal instructions. May instruct others in the use of all manuals, test procedures and documentation associated with specialized equipment.Reads and interprets engineering drawings, schematics and complex test procedures.Participates in continuous improvement/quality initiatives in order to enhance production processes to achieve quality and profitability metrics.Maintains accurate records to ensure Device History Records and quality documents are accurate, all parts are traceable and quality issues can be addressed to assure the quality of all products.Prioritizes work by determining the sequencing and timing of different jobs