Job Description

Quality System Assistant

Permanent Full-Time

Shifts: Office, Days Monday-Friday

Salary Range: $00.00 Salary / Hourly?

Location: Milton, ON

Job Overview:

As Quality System Assistant, you will be supporting the Quality Manager by organizing the information and documentation required to ensure that the company produces quality products in line with customer and regulatory standards.

Essential Functions and Responsibilities:

Support the Quality Manager in maintaining the Quality Management System (QMS) in accordance with 21 CFR 820 and its updates. Draft and implement quality assurance policies and procedures while maintaining document controls. Evaluate the implementation and efficacy of the quality systems, evaluate audit findings, make the necessary recommendations to ensure regulatory compliance. Introduce and support innovative approaches to current best practices while simultaneously working with the team to document new policies and practices as required. Assist in Medical Device (MD) reporting and issue any corrective and preventive actions, when necessary, based on deviations found in manufacturing processes, audits, customer or customer feedback. Assist with preparation and support third-party audits and FDA regulatory inspections. Ensure employees are fully trained on Quality Assurance subject matter, identify training needs supporting the quality programs and organize training. Co-ordinate and document equipment calibrations, customer portal subscriptions, product testing, certifications, and audit scheduling, in a timely manner. Complete customer surveys, questionnaires, and self-declarations compliant with regulations based on customer requests. Conduct root cause analysis to solve quality related non-conformities and work on solving the most critical items based on risk assessments. Follow the guidelines and rules as set out by company policies. Treats everyone with dignity, trust, and respect. Completes other duties as required by the Quality Manager.

Skills & Competencies:

Minimum 2-4 years of experience in Document Control in Quality Department, preferably in Medical Device manufacturing/ FDA regulated manufacturing. Strong understanding of FDA cGMP, MDR, and 510(k) clearance programs Competence in Microsoft Office (Word, Excel) Must be a strong communicator with attention to detail Problem solving and continuous improvement SAP experience is an asset

Education and Training:

Post secondary education in a related field Working knowledge of ISO 9001 and ISO 13485 * Certified Quality Auditor (CQA) certification is an asset