Job Title: Quality Systems Engineer

For immediate consideration, please apply directly to this job posting AND email dfarrand @actalentservices.com with the following: 

1) Word copy of resume

2) 2-3 professional references

3) 4-5 brief bullet points highlighting technical qualifications

Job Description

We are seeking an experienced Quality Systems Engineer to ensure that our Quality System is compliant with industry standards and regulations. The ideal candidate will promote awareness of the Quality System, provide training across the organization, and implement quality methods throughout the organization. You will be responsible for creating, editing, and maintaining documentation, defining processes and technical solutions, and supporting regulatory submissions.

ResponsibilitiesEnsure compliance with 21 CFR 820, 803, 806 and other relevant regulations.Promote awareness of the Quality System and provide training on quality management philosophies, tools, techniques, and best practices.Provide training and direction to junior team members.Implement quality methods and drive the use of quality tools in operations and product development.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).Define, develop, and implement processes and technical solutions to support product and process quality.Assist with the development and validation of test methods addressing User Needs and Design Specifications.Prepare and maintain documentation suitable for regulatory submissions for IDE human clinical studies.Support preparation and maintenance of compliance to ISO Risk Management.Assist in conducting risk management activities and updating FTA, FMEA, etc.Coordinate and oversee sterilization validation activities.Coordinate and oversee maintenance of clean room environments (min. class 8).Review and approve Device History Records.Assist with the implementation and validation efforts for new facility locations, materials, equipment, processes, and components.Ensure systematic planning and controlling of product and process quality in manufacturing.Conduct inspection of components and subassemblies and document compliance to approved specifications and procedures.Initiate and coordinate laboratory testing of raw materials, assemblies, finished goods, and environmental conditions.Develop quality agreements and quality control plans in collaboration with suppliers.Lead supplier audits and participate in supplier responses to queries during and following the audit.Handle and investigate complaints, CAPA, and guide failure investigations.Implement and support quality improvement models, corrective and preventive actions.Participate in external audits and develop responses to queries during and following the audit.Initiate action to prevent non-conformities and follow through the non-conformance and failure investigation process.Essential SkillsBachelor’s degree or higher in Biomedical Engineering or similar.8+ years of work experience in medical device development or quality assurance.At least 5 years of experience at a class II or III medical device company.Experience with electrical/mechanical systems for medical devices in a regulated environment.Thorough 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.Thorough knowledge of statistical analysis, reliability, maintainability, and risk management.Working knowledge of quality systems, risk management tools, and applicable standards such as FMEA, QSR, ISO, 21 CFR Part 820, 803, 806.Working knowledge of gauges and precision inspection equipment/instruments.Additional Skills & QualificationsVentricular Assist Device experience would be highly valued.Experience in a Design Assurance role through all phases from product conception through commercialization.Work Environment

This position is within a medical device manufacturing startup with currently 22 employees. Our client is a preclinical stage medical device company developing the first long-term therapy for patients with severe heart failure. The work environment includes a clean room environment (min. class 8), and involves interaction with external suppliers and participation in external audits. The company offers opportunities for tremendous growth, holiday pay, and PTO.

Pay and Benefits

The pay range for this position is $120000.00 - $130000.00

Generous benefits: bonuses, 401K matching dollar for dollar up to 6%, and a 4% non-elective contribution (if they put in 6%, they get 10%); 4 weeks of vacation; stock options; many health plans offer 100% coverage for the employee, depending on the benefits.

Workplace Type

This is a fully onsite position in Huntington Beach,CA.

Application Deadline

This position will be accepting applications until Dec 24, 2024.

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

Diversity, Equity & Inclusion

At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:

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 people

The 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.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.