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Job Title: Quality EngineerJob Description

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

Responsibilities

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

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

+ Coordinate new process techniques that enhance overall job efficiencies.

+ Implement quality systems and procedures to ensure compliance with Quality Standards.

+ Participate in Design Development Process meetings representing quality, where appropriate.

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

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

+ Manage equipment and process validation activities for development programs.

+ Manage acceptance of product & deliverables.

+ Participate in development teams, as appropriate.

+ Provide direct feedback into 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 internal/external customer satisfaction.

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

+ Monitor manufacturing of assigned products, ensuring compliance with DMR while providing deviation/waiver guidance and maintaining complete and correct Device History Records.

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

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

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

+ Develop various inspection techniques and procedures to ensure product integrity to design specifications. Responsible for writing, approval, and implementation of 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 re-occurrence.

+ Lead and manage complaint investigations.

+ Participate in plant CAPA activities, including analysis of data and trends 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

+ Proficiency in quality engineering and quality assurance.

+ Experience in CAPA and ISO standards.

+ Familiarity with device documentation.

+ Ability to perform IQ/PQ validations.

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 engineering, manufacturing, and quality teams. It requires travel to other facilities as needed to support business needs and involves participation in regulatory inspections and audits. The role also involves mentoring and supporting quality inspectors and technicians.

Pay and Benefits

The pay range for this position is $40.00 - $48.00/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 26, 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.