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Job Title: Quality Engineer

Job Description

The Quality Engineer plays a crucial role in directing quality assurance efforts to ensure that products conform to quality and regulatory standards. This role involves establishing and maintaining quality assurance procedures and controls, as well as managing microbiological procedures, including sterilization, bioburden, residuals, and environmental monitoring. The position supports the Corrective and Preventive Action System (CAPA), Complaint System, Material Review Board (MRB) System, Internal Audit System, and Management Review System. Additionally, the Senior Quality Engineer ensures organizational compliance with quality systems and standards such as FDA QSR/GMP regulations, ISO standards, and the Medical Device Directive (MDD) in product development and manufacturing.

Responsibilities

+ Serve as a technical resource for initiating and implementing cost improvement plans on new and existing programs.

+ Perform validations (IQ, OQ, PQ, MSA, CQ) in accordance with company SOPs.

+ Coordinate new process techniques to improve overall job efficiencies.

+ Implement quality systems and procedures to ensure compliance with quality standards.

+ Participate in Design Development Process meetings as a quality representative.

+ Facilitate communication between engineering, manufacturing, and quality both internally and externally.

+ Contribute to the design and development of components, assemblies, and devices.

+ Manage equipment and process validation activities for development programs.

+ Manage acceptance of products and deliverables.

+ Participate in development teams as appropriate.

+ Provide direct feedback on product/process quality-related decisions.

+ Travel to other facilities may be required to support business needs.

+ Actively participate in continual improvement/innovation, corrective action, and customer satisfaction.

+ Support regulatory and agency inspections, audits, investigations, and inquiries regarding product design and manufacturing quality.

+ Monitor manufacturing of assigned products to ensure compliance with DMR and maintain complete and correct Device History Records.

+ Review the adequacy and correctness of changes to Bill of Materials (BOMs), Assembly Procedures, Drawings, Component Specification, FMEAs, and Control Plans.

+ Lead the generation and completion of protocols and reports for test method validations.

+ Interface with Manufacturing to review processes for new and existing products, coordinate process validations and capability studies, and recommend process monitoring devices where applicable.

+ Develop various inspection techniques and procedures to ensure product integrity to design specifications, including writing, approving, and implementing Incoming, In-Process, and Final Inspection procedures.

+ Ensure the disposition of non-conforming materials meets all necessary regulatory requirements and ensure adequacy of corrective actions to prevent recurrence.

+ Lead and manage complaint investigations.

+ Participate in plant CAPA activities, including data analysis and trend analysis in complaints, supplier quality, nonconforming material, training effectiveness, and root cause analysis.

+ Participate in continuous improvement projects.

+ Assist with product transfers.

+ Work with suppliers, management, engineers, and manufacturing associates to resolve quality problems.

+ Mentor and support quality inspectors and technicians.

+ Perform other functions as required.

Essential Skills

+ Quality engineering

+ Quality assurance

+ CAPA

+ ISO standards

+ 5Y

+ TMV

+ IQ/PQ

+ Documentation

Additional Skills & Qualifications

+ Bachelor’s degree in engineering (mechanical, electrical, biomedical, or related field) with 1-3 years of experience in Quality Engineering in a regulated medical device or pharmaceutical industry.

+ Master’s degree in engineering (mechanical, electrical, biomedical, or related field) with 1-3 years of experience in Quality Engineering in a regulated medical device or pharmaceutical industry.

Work Environment

The work environment involves collaboration with cross-functional teams, including engineering, manufacturing, and quality assurance. The role may require travel to other facilities to support business needs. It demands a thorough understanding of regulatory requirements and the ability to perform in a fast-paced, dynamic setting. Dress code and facility conditions align with industry standards for quality assurance roles in the medical device and pharmaceutical sectors.

Pay and Benefits

The pay range for this position is $50.00 - $55.00/hr.

Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following:

• Medical, dental & vision • Critical Illness, Accident, and Hospital • 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available • Life Insurance (Voluntary Life & AD&D for the employee and dependents) • Short and long-term disability • Health Spending Account (HSA) • Transportation benefits • Employee Assistance Program • Time Off/Leave (PTO, Vacation or Sick Leave)

Workplace Type

This is a fully onsite position in Agoura Hills,CA.

Application Deadline

This position is anticipated to close on May 27, 2025.

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.

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 due to a disability, please email [email protected] (%[email protected]) for other accommodation options.