Quality Assurance and Compliance Specialist needed for a HealthTech manufacturing company located near the Irvine Spectrum. Ideal candidate will have a strong background in Quality Systems (both ISO 13485 and 9001).
This is a Temporary to Hire position, may consider Direct Hire depending on the candidate. Paying $75,000 - $100,000/yr, depending on experience. Hours are, Monday - Friday, 8:00 AM - 5:00 PM (1 hour lunch) – can flex to 30 minute lunch if desired. Company has excellent benefits include 100% paid Medical, Dental, and Vision insurance for the employee and family members. This company takes pride in providing exceptional care for its employees and fostering a fun and engaging work environment.
Monitors appropriate record keeping systems and effective Quality Assurance systems, reacts to problems following company policies and procedures while maintaining data integrity. Assist with the comprehensive filing system and computer database for all documents to be retained by document control. Must be able to read and follow detailed written instructions and have good verbal/written communication skills. Completes projects or other duties as assigned by the Director of Quality or the PI Leadership Team. The position interacts with suppliers and customers alike, in addition, they will provide support for Production, Engineering, and Quality related activities.

CRITICAL EXPERIENCE & KNOWLEDGE:

• Years of Experience = Bachelors in Science, Engineering or related area of study with 3+ Years in a QA/Regulatory role, working within a regulated industry.
• Knowledge of ISO 13485, ISO 9001, ISO 14971 standards, 21 CFR 820 and cGMP compliance.
• Strong communication, organizational, planning and leadership skills.
• Ability to develop and/or conduct quality training programs.
• Ability to read drawings and good understanding of geometric tolerancing.
• Knowledge of change orders, releasing documents and training records.
• Excellent computer skills in Microsoft Office, Word, Excel, PowerPoint, Power BI. Is willing to learn and operate in new systems.
• Understands process flow/flow charts and the basics of creating them.
• High attention to detail
• Proactive, self-directed, and able to facilitate discussions.
• Works well in environments with changing priorities.
  Job Type: Full-time
  Pay: $75,000.00 - $100,000.00 per year
  Work Location: In perso

PRIMARY RESPONSIBILITIES:

• Maintenance of document control procedures including evaluation, investigation and execution of releasing documents and archiving of documentation to ensure traceability and accessibility with overall evaluation, investigation and execution of change orders with a high level of accuracy.
• Assist other departments in creating/ redlining procedures, work instructions and forms.
• Ensure compliance with the company’s Quality System policies and procedures and applicable external requirements and standards, including FDA, ISO 9001, ISO 13485, ISO 14971, and other worldwide regulatory agencies as pertaining to medical devices.
• Assistance in maintaining training records systems, sustaining and updating of the training Matrix.
• Actively support and execute quality system activities and elements (e.g., management review, Internal audit, Customer Audits, Quality and Complaint metrics and trends, Supplier Audits or regulatory audits).
• Assessment and qualification of suppliers, including low cost regions.
• Coordinate MRB meetings, facilitate root cause meetings ensuring that appropriate corrective actions are implemented to address root cause, assist with tracking of Quality event actions items and event closure.
• Provide support (management/execution) with CAPA, change requests, deviations, NCPs.
• Participate in calibration related activities such as schedule calibrations, review, and file records.
• Monitors new regulatory standards implementation and revisions to current standards, i.e., ISO Standards, FDA Requirements, ASTM.
• Maintaining document control activities including scanning of records and managing on and off site storage.

SECONDARY RESPONSIBILITIES:

• Support and coordinate product/process improvements through collaboration with cross-functional teams (Quality, Manufacturing, R&D, Supply Chain, Finance, etc.).
• Identify continuous improvement opportunities for the Quality Management System.
• Assisting the broader PI team with various compliance requirements such as GDPR, Electronic Records, RoHS and REACH, etc.
• Perform Quality Control activities as required.
• Assist in the creation, closure review and verification of completion of batch records and release products and issuance of certificates of compliance to ensure product produced meet the customer and regulatory requirements.
• Other duties as required commensurate with your skills and experience.