Quality Assurance Lead

2 weeks ago

Valencia, California, United States TriMed Inc Full time
Job Overview

This document outlines the essential nature and level of work expected from individuals in this role. It is not intended to be an exhaustive list of all responsibilities, duties, and skills required.

Position Objective

The Quality Assurance Lead collaborates across various departments including Engineering, Product Management, and Inventory, as well as with global partnerships and joint ventures. This hands-on role emphasizes teamwork, adaptability, risk-based decision-making, and flexibility. The individual will oversee the Quality Management System (QMS) and work with a diverse team, demonstrating self-motivation and possessing strong written and verbal communication skills. A key responsibility is to foster a company-wide culture of quality and ensure effective collaboration with other departments to meet organizational goals.

In all activities, this role prioritizes patient safety and product quality by adhering to the Quality Policy and all documented quality processes and procedures.

Key Responsibilities

The following duties may be included:

  • Act as the Management Representative (MR).
  • Assist in the development and updates of post-market surveillance initiatives.
  • Support the organization in acquisitions and joint ventures to ensure Quality Systems align with organizational needs and comply with global regulatory standards.
  • Oversee all Quality functions, including the creation and revision of operating and quality procedures, addressing customer feedback and complaints, corrective and preventive actions, control of nonconforming materials, supplier quality, internal audits, design controls, and document management.
  • Manage Quality personnel responsible for quality assurance in new product development, supplier quality, and monitoring the Quality Management System.
  • Provide mentorship, guidance, and training to team members, assist them in achieving career aspirations, motivate individuals to deliver results, and recruit and retain a high-caliber team.
  • Lead Management Review meetings by coordinating data collection and presenting information to the management team to ensure the QMS is appropriate, sufficient, and effective.
  • Support new product development initiatives.
  • Monitor and analyze trends in process and product performance, including supplier performance.
  • Provide leadership across all facets of the Quality System.
  • Coordinate quality initiatives with other departments within the organization.
  • Communicate effectively at all levels within the Quality department and across functions such as Engineering, Product Management, and Purchasing.
  • Perform additional duties as assigned.

Qualifications

Proficient knowledge in the following areas:

  • FDA Quality System Regulations (QSR), including establishment registration and new product submissions.
  • ISO 13485:2016 and EN ISO 13485:2016 standards.
  • Medical Device Directive (MDD) 93/42/EEC, including CE Mark applications and Technical Files.
  • EU Medical Device Regulation (MDR) 2017/745.
  • Risk Management principles, ISO 14971:2019.
  • Medical Device Single Audit Program (MDSAP).
  • Canadian Medical Device Regulations (CMDR), including licensing.
  • Brazilian Health Surveillance Agency (ANVISA) Resolution RDC no. 2, including approvals and registrations.
  • Australian Therapeutic Goods (Medical Devices) Regulations.
  • Japanese MHLW MO169 regulations.
  • Bachelor's Degree in Engineering or a related technical/scientific field is preferred.
  • A minimum of 6 years of experience in quality assurance within an FDA-regulated environment.
  • Experience in leading a team of professionals through coaching, leadership, and direction.
  • Strong problem-solving, decision-making, and root cause analysis skills are essential.

Working Environment

  • This role is situated in an open office setting.
  • Regular communication is required, necessitating the ability to talk and hear.
  • Frequent standing, walking, and sitting are part of the job.
  • Travel may be required up to 20% of the time.

Physical Demands

  • Work is primarily conducted in an office environment, involving prolonged periods of sitting.
  • Occasional lifting or moving of items up to 25 pounds may be necessary.

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