Quality Engineer - Contract

Job Description

Job Description

To assist in maintaining Quality Assurance and Control practices in adherence to the Food and Drug Administration (FDA) regulations for the Quality System Regulation and for ISO 13485 standards, the QE must be well-rounded and technically oriented so that he/she can support Manufacturing, Process Engineering, and R & D quality engineering tasks.

ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned.

• Collaborates with manufacturing engineering and manufacturing functions to ensure quality standards are in place.

• Devises and implements methods and procedures for inspecting, testing, and evaluating the precision and accuracy of products and production equipment.

• Use knowledge of statistics on acceptance criteria, DOE, and comparison testing to support development engineers in the development of compliant test plans and reports to meet regulatory requirements and quality objectives.

• Supports manufacturing continuous improvement and development as the Quality team member for validation including IQ, OQ, PQ, and test method validation.

• Generate and/or apply statistical methods with appropriate risk-based justification.

• Track nonconforming material and leads Material Review Board (MRB) efforts. Interface and take the lead QA role in interactions with suppliers, contractors, and consultants that supply components, subassemblies, and contract processing. Lead complaint investigations on the returned product. Manage corrective action and quality improvement activities.

• Support risk assessment processes for manufacturing and development including FMEA, ensuring risk assessments are thorough and documentation meets all governing requirements.

• Define critical quality characteristics and inspection plans for components, subassemblies, and finished devices.

• Identify and propose remediation for existing and potential quality issues; act as project team quality solution provider to maintain compliance.

• Ensure that product development projects and changes to existing products are conducted in compliance with the FDA Quality System Regulation, ISO 13485 Regulations, and other applicable standards.

• Maintain expertise in both current and emerging requirements and quality trends as they relate to medical device products worldwide.

• Facilitate group meetings and project leadership that drive to comprehensive technical solutions for multiple issues and projects simultaneously.

• Ensure internal quality processes, procedures and systems are compliant with all governing standards.

• Participate in and assist with internal audits. Supporting in corrections needed or CAPA that may result from the Audits.

• Manage, and measure the effectiveness of the Corrective and Preventive Action Processes including Internal and External Audit Processes.

• Report key metrics and trends to top management such as non-conformances, deviations, and CAPAs in weekly meetings.

• Independently provide comprehensive technical solutions for complex issues related to quality processes, procedures, and systems to meet organizational objectives.

• Other duties as assigned

Job Requirements

QUALIFICATIONS

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions.

EDUCATION and/or EXPERIENCE

• BS Engineering - Mechanical, Industrial/Manufacturing, Biomedical engineering, or science technical discipline

• 5+ years’ experience in engineering, science, technical and/or quality.

• Strong understanding of medical device manufacturing processes and products

• Experience with general quality principles, procedures, and methodologies

• Strong understanding of regulatory requirements (i.e.: ISO, FDA-GMP, etc.)

• Strong statistical analysis techniques

• Strong technical writing skills

• Execution of NCR and CAPA Processes

• Process Validations - IQ/OQ/PQ's

Position Type/Expected Hours of Work

This is a full-time position. Hours of work are Monday through Friday, 7:00 a.m. to 4:00 p.m., 40 hours per week.

The annual pay range for this position is $33-36/hr

The pay offered for this role may be influenced by factors such as job location, scope of role, qualifications, education, experience, & complexity/specialization/scarcity of talent.

Company Description

Carl Zeiss Meditec Production, LLC is located in the city of Ontario in California, about 40 miles (64 km) east of Los Angeles.

Founded in 1989 as Oii, later Aaren Scientific, the company was an early innovator in computer-controlled intraocular lenses (IOL) production, and was the first U.S. IOL manufacturer to be awarded CE registration.

The company has been integrated into ZEISS Medical Technology Business Group, and complements the existing ZEISS IOL development and manufacturing sites.