Job Description

_JOIN IS A MOLECULAR INFORMATION COMPANY DEDICATED TO A TRANSFORMATION IN CANCER CARE IN WHICH TREATMENT IS INFORMED BY A DEEP UNDERSTANDING OF THE GENOMIC CHANGES THAT CONTRIBUTE TO EACH PATIENT'S UNIQUE CANCER. _ Title: QA Engineer II Location of Assignment: Starting Remote/ San Diego, CA Contract Length: 3 months (W2), potential for extension/conversion pending Pay: Competitive rates/ based on qualifications  Benefits Offered: Medical, Dental, Vision Duties: The Quality Engineer II in the Quality Assurance department is a key and critical role at FMI. This role will present the incumbent with an opportunity to work with various teams. As part of the Lab Operations Quality team, this position will be supporting day-to-day quality management laboratory activities that provide the insights that directly help the doctors match patients to more treatment options. This role will support the harmonization of the validation program at San Diego within SOPs. This position supports the planning and work of multiple project and scrum teams with a big picture mindset and is accountable for achieving all related business goals. This role will:

• Assist in managing the Requalification schedule of laboratory equipment
• Review and Approve Validation plans, protocols and reports.
• Assess Change Controls for Validation Impact.
• Collaborates with stakeholders, engineers, SMEs, and cross functional team members in equipment qualification efforts at FMI facilities.
• Participates in continuous improvement and validation maintenance efforts.

Key Responsibilities

• Participate in the development and approval for design and development documents, quality system procedures, and laboratory documentation and controls. ·
• Be a subject matter expert for audit-related questions within their subject matter area including front room and back room support and management for FDA, Notified Body, or pharma partners.
• Ensure all activities are conducted in compliance with the FMI Quality Management System, appropriate regulations, international and national regulations and are aligned with regulatory agency expectations.
• Effectively collaborate with a fully integrated team to facilitate the completion of documents.
• Maintain Quality Management Systems for functional area including Design Controls, Software
• Development, Risk Management, Corrective and Preventative Action (CAPA) system and Non-Conforming Material Reports.
• Conduct root cause analysis and implementation of correction, corrective and preventative actions and verification of effectiveness of actions as periodically required in the identification and resolution of issues.
•  Other duties as required

Basic Qualifications

• Experience in biopharmaceutical/biotechnology GxP environment.
• Combination of equipment qualification, process validation, computer systems, cleaning, and sterilization is acceptable.
• Quality experience with in-depth knowledge of Validation approach, cGxP standards and Risk based validation.

Preferred Qualifications

• Advanced Degree in the Sciences, Engineering, Business or a related field
• Experience with next generation sequencing methodology
• Experience with IVD, Medical Device product development, analytical validation and product approval, manufacturing and/or lab operations
• Demonstrated ability to lead, communicate, interact and influence effectively at technical levels across functions
• Demonstrated capacity to work in a fast-paced environment with strong attention to detail
• Evidence of knowledge of molecular biology
• Evidence of practical knowledge of standards and regulations pertaining to the medical device industry, both domestic and international; in particular, standards set forth by the International Electrotechnical Commission and International Organization for Standardization 
• Deep knowledge of bioanalytical assay development, qualification, and validation requirements that comply with current regulatory standards
• Comprehensive knowledge of Good Manufacturing Practices and Good Documentation Practices
• Working knowledge of Next Generation Sequencing
• Proficiency in Microsoft Office, Word, Excel, Project and PowerPoint
• Proficiency in relevant analytical methodology and emerging new technologies
• Excellent communication skills and proven ability to work effectively as a member of a multidisciplinary team
• Strong skills in troubleshooting and problem solving
• Understanding of HIPAA and importance of privacy of patient data

Education:

• Bachelor's Degree in a science or engineering discipline and 5+ years of experience in the medical device, diagnostics, clinical laboratory or biopharmaceutical industry; OR,
• Master's Degree in a science or engineering discipline and 3+years of experience in the medical device, diagnostics, clinical laboratory or biopharmaceutical industry

Company Description

Designer, producer and retailer of luxury eyewear and provider of one of the top vision insurance programs across the world. Supporting all aspects of vision, this company offers opportunity and growth in operations and corporate structure.