**Immediate Quality Engineer Opportunity**
**For Immediate Consideration please apply to this posting and email your resume to habels@actalentservices.com**
Description:
-\tEnsure that the Quality System is compliant with 21 CFR 820, 803, 806 and ISO 13485.
-\tPromote awareness of the Quality System and provide training to individuals across the organization on quality management philosophies, tools, techniques and best practice.
-\tProvide training and direction, as required, to junior team members with the organization.
-\tImplement quality methods throughout the organization, drive the use of quality tools in operation and product development, assist in resolving major product related issues
-\tCreate, edit, and maintain documentation related to design controls and quality system guidelines.
o\tAssist in the development of design input specifications and study designs.
o\tWrite and review Standard Operating Procedures (SOPs) and Work Instructions (WIs).
-\tDefine, develop and implement processes and technical solutions to support product and process quality in accordance with quality principles which includes material control, acceptance sampling, and measurement systems.
-\tAssist with the develop and validation of test methods addressing the User Needs and Design Specifications.
-\tWith the assistance of Quality and Regulatory personnel prepare and maintain documentation suitable for regulatory submissions for IDE human clinical studies.
-\tSupport preparation and maintenance of compliance to ISO 14971 Risk Management. Assist in conducting risk management activities and updating FTA, FMEA, etc.
-\tCoordinate and oversee sterilization validation activities.
-\tCoordinate and oversee maintenance of clean room environments (min. class 8).
-\tReview and approve Device History Records.
-\tAssist with the implementation and validation efforts for new facility location, new/changed materials, equipment, processes and components.
-\tEnsure systematic planning, and controlling of product and process quality in manufacturing
o\tProcesses for planning product and service development
o\tMaterial control
o\tAcceptance activities
o\tMeasurement systems
-\tConduct inspection of components and subassemblies as required and document compliance to approved specifications and procedures.
-\tInitiate and coordinate laboratory testing of raw materials, assemblies, finished goods and environmental conditions.
-\tInteract with external suppliers.
o\tDevelop quality agreements and quality control plans in collaboration with suppliers.
o\tLead supplier audits and participate in supplier visits.
o\tDevelop responses to queries during and following the audit
-\tQuality System Support
o\tComplaint handling and investigation
o\tCAPA handling and investigation
o\tGuidance for completion of failure investigations
-\tImplement and support quality improvement models, corrective and preventive action, overcoming barriers to quality improvement.
o\tParticipation in external audits – develop response to queries during and following the audit.
-\tInitiate action to prevent occurrence of non-conformities relating to the product, process and quality system and follow through the non-conformance and failure investigation process affecting Quality, and report verbally and in writing to the executive team regarding the progress and results of projects.
Skills:
Inspection, Quality control, Quality assurance, Quality inspection, Engineering, Troubleshooting, work orders, Schematic, Mechanical, Electrical, Visual inspection
Top Skills Details:
Inspection,Quality control,Quality assurance,Quality inspection,Engineering,Troubleshooting,work orders
Additional Skills & Qualifications:
-\tBachelor’s degree or higher in Biomedical Engineering or similar, 8+ years work experience in medical device development or quality assurance.
-\tAt least 5 years working at a class II or III medical device company. Ventricular Assist Device experience would be highly valued.
-\tExperience with electrical/mechanical systems for medical devices in a regulated environment.
-\tThrough understanding of design control requirements, verification, and validation for medical devices.
-\tThorough understanding of quality philosophies, principles, systems, methods, tools, standards, organizational and team dynamics customer expectations and satisfaction, supplier relations and performance, leadership, training, interpersonal relationships, improvement systems, and professional ethics.
-\tThorough understanding of a quality system and its development, documentation and implementation with respect to domestic and international standards and requirements.
-\tThorough understanding of the audit process, including types of audits, planning, preparation, execution, reporting results and follow-up.
-\tAbility to develop and implement quality programs, including tracking, analyzing, reporting and problem solving.
-\tThorough understanding of problem solving and quality improvement tools and techniques, including management and planning tools, preventive and corrective actions, and how to overcome barriers to quality improvements.
-\tThorough knowledge of statistical analysis, reliability, maintainability and risk management, including key terms and definitions, modeling, systems design, assessment tools and reporting.
-\tWorking knowledge of quality systems, risk management tools and applicable standards, such as FMEA, QSR, ISO 14708, ISO 17025, ISO 14971, ISO 13485, 21 CFR Part 820, 803, 806.
-\tWorking knowledge of gauges and precision inspection equipment/instruments.
-\tExperience in a Design Assurance role with experience through all phases (from product conception through commercializa
Experience Level:
Intermediate Level
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Hiring diverse talent Maintaining an inclusive environment through persistent self-reflection Building a culture of care, engagement, and recognition with clear outcomes Ensuring growth opportunities for our peopleThe company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
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