Senior Quality Engineer - medical device - InnoTech Staffing

InnoTECH Staffing is looking to hire a Senior Quality Engineer for an exciting and growing medical device company in Huntington Beach, CA.


Quality Engineer III
Be an integral member of the quality team in supporting the quality related activities associated with the manufacture, test and distribution of the medical system. The QE III will also work with senior management to implement and supports maintenance of quality management system in accordance with ISO 13485 and 21 CFR 820, 803, and 806.

Assist in the management of daily QA activities including developing and performing of validation & verification tests, completion of incoming, in-process and final inspection of assemblies and devices.

Work with internal engineering staff from mechanical, electrical and software engineering backgrounds to support manufacturing process development and maintenance.

Assist with elements of design control such as requirements, system hazards analysis, design and process FMEAs.

Act as a liaison between the company and external suppliers to ensure QA activities are sufficiently undertaken to support product development.

Identify and record potential problems relating to the product, process and Quality System. QE III will initiate, recommend or provide solutions through designated channels. Will then record and/or report all instances of customer feedback on product.

Verify the implementation of solutions.



We are looking for motivated team members, who are keen to contribute to this active and dynamic project. This role requires creativity and flexibility, strong organizational, time management, and technical skills. Analytical and problem-solving skills with the ability to multitask in a deadline driven environment, while working with minimal or no supervision is essential.


Responsibilities
o Ensure that the Quality System is compliant with 21 CFR 820, 803, 806 and ISO 13485.
o Promote awareness of the Quality System and provide training to individuals across the organization on quality management philosophies, tools, techniques and best practice.
o Provide training and direction, as required, to junior team members with the organization.
O Implement quality methods throughout the organization, drive the use of quality tools in operation and product development, assist in resolving major product related issues
O Create, edit, and maintain documentation related to design controls and quality system guidelines.

• Assist in the development of design input specifications and study designs.
• Write and review Standard Operating Procedures (SOPs) and Work Instructions (WIs).

O Define, 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.

• Assist with the development and validation of test methods addressing the User Needs and Design Specifications.
• With the assistance of Quality and Regulatory personnel prepare and maintain documentation suitable for regulatory submissions for IDE human clinical studies.

o Support preparation and maintenance of compliance to ISO 14971 Risk Management. Assist in conducting risk management activities and updating FTA, FMEA, etc.
o Coordinate and oversee sterilization validation activities.
o Coordinate and oversee maintenance of clean room environments (min. class 8).
o Review and approve Device History Records.
o Assist with the implementation and validation efforts for new facility location, new/changed materials, equipment, processes and components.
o Ensure systematic planning, and controlling of product and process quality in manufacturing

• Processes for planning product and service development
• Material control
• Acceptance activities
• Measurement systems

o Conduct inspection of components and subassemblies as required and document compliance to approved specifications and procedures.
o Initiate and coordinate laboratory testing of raw materials, assemblies, finished goods and environmental conditions.
o Interact with external suppliers.

• Develop quality agreements and quality control plans in collaboration with suppliers.
• Lead supplier audits and participate in supplier visits.
• Develop responses to queries during and following the audit

o Quality System Support

• Complaint handling and investigation
• CAPA handling and investigation
• Guidance for completion of failure investigations

o Implement and support quality improvement models, corrective and preventive action, overcoming barriers to quality improvement.

• Participation in external audits – develop response to queries during and following the audit.

o Initiate 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.

Requirements

• Bachelor’s degree or higher in Biomedical Engineering or similar, 8+ years work experience in medical device development or quality assurance.
• At least 5 years working at a Class II or III medical device company. Ventricular Assist Device experience would be highly valued.
• Experience with electrical/mechanical systems for medical devices in a regulated environment.
• Through understanding of design control requirements, verification, and validation for medical devices.
• Thorough 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.
• Thorough understanding of a quality system and its development, documentation and implementation with respect to domestic and international standards and requirements.
• Thorough understanding of the audit process, including types of audits, planning, preparation, execution, reporting results and follow-up.
• Ability to develop and implement quality programs, including tracking, analyzing, reporting and problem solving.
• Thorough 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.
• Thorough knowledge of statistical analysis, reliability, maintainability and risk management, including key terms and definitions, modeling, systems design, assessment tools and reporting.
• Working 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.
• Working knowledge of gauges and precision inspection equipment/instruments.
• Experience in a Design Assurance role with experience through all phases (from product conception through commercialization) desirable.
• Proficient with Microsoft Office. Experience with project planning software packages, DAQ systems and interface with Matlab is highly desirable.
• Desirably holds certification/qualification from the American Society for Quality: CQE, CRE, CSQE, or CBA.