Manager Medical Device jobs in Ontario

Overview

ENABLE your future through light.

Excelitas is a global technology leader with more than 7,500 employees, focused on delivering market-driven solutions to fulfill the illumination, optical, detection and imaging needs of OEMs and end-users across the biomedical, semiconductor, industrial, consumer products, scientific, security, defense and aerospace sectors.

The Quality Manager plays a vital role in leading quality improvement initiatives at the site to enhance manufacturing operations, reduce the cost of poor quality, meet on-time delivery expectations, and ensure customer requirements are met. The role oversees various quality functions, including Quality Assurance (Incoming, In-Process, and Final), Quality Control, Quality Engineering, Document Control, Supplier Quality, and Metrology. In addition, the QA&QS Manager is tasked with cultivating a culture of continuous improvement and operational excellence, with a focus on improving and optimizing the Quality Management System (QMS). Acting as the primary liaison for External and Internal Audits, the Quality Manager ensures that product and process compliance not only meets but exceeds industry standards, customer expectations, and regulatory requirements. This position is an on-site role based out of the Mississauga office.

Main Responsibilities:

Quality Assurance Management

• Lead quality reviews meetings to identify quality issues, develop action plans, and ensure follow through until issues are resolved
• Be the organizational change agent in order to improve quality methods by liaising with customers, auditors, and ensuring the execution of corrective action and compliance with customers' specifications
• Promote quality achievement and performance improvement throughout the organization
• Develop and implement quality systems for internal audits, process audits, supplier quality, lean manufacturing, cost of quality and employee empowerment
• Develop procedures and systems to check conformance of materials by assessing the product specifications of the company and its suppliers, and comparing them with customer requirements
• Evaluate and develop new and existing suppliers to ensure their process capabilities meet technical and regulatory requirements, collaborating closely with the supply chain and purchasing teams to define quality expectations, drive continuous supplier performance improvement, and implement corrective and preventive actions that strengthen overall supply quality.
• Identify and establish quality requirements for new product development process which includes the development of supplier quality plans, ensuring compliance with national and international standards
• corrective & preventive actions (CAPA)
• Identify and provide recommendations on all concerns stemming from an environmental aspects or incidents
• Initiate continuous improvements on methods and processes to achieve zero-defects and customer satisfaction through elimination of customer complaints and other field failure
• Manage the site’s Material Review Board program for Non-Conforming material disposition
• Other duties as assigned

Quality Systems Management

• Ensure that processes needed for the quality system are established, implemented and maintained. Ensure that the Quality Management System is documented and meet the requirements of the ISO 9001, ISO 13485, ISO 14001 and FDA QSR standards. Develop suitable processes for the effective planning, operation and control of these processes
• Report to top management on the performance of the quality management system and any need for improvement. Collect and collate the inputs required for Management reviews. Ensure that management reviews are conducted as planned
• Ensure the promotion of awareness of Customer requirements throughout the organization. Provide the necessary training and awareness of the Quality Management System to personnel, including changes to processes as applicable
• Responsible for the implementation of business process improvements, as applicable, resulting from preventive or continual improvement processes

Requirements:

• 5+ years’ experience in Quality Management
• Post-secondary education (from a recognized educational institution) in Engineering, Quality, or related discipline
• Computer literate with good working knowledge of Microsoft Office products
• Ability to work within computerized environments such as, ERP and PLM
• Strong analytical skills and experience with implementation and administration of Quality Assurance metrics
• Excellent problem solving and interpersonal/communication skills
• Must be extremely detail-oriented with respect to documentation and communication
• Strong leadership skills that inspire team confidence and respect while motivating team members in a creative and effective manner, driving a high-performance culture within the team
• Must have a desire for achieving excellence in customer satisfaction, process and product quality and reliability
• Must be proficient in ISO quality management system standards such as ISO 9001, ISO14001, ISO 13485, and FDA QMSR
• Must have successfully completed an Auditor’s certification training program, and/or ASQ certifications
• Experience in Supplier Quality Management
• Excellent English verbal and written communication skills for report writing, documentation etc.
• Knowledge and experience with continuous improvement techniques such as LEAN, Six Sigma, Kaizen, etc.
• Ability to work in a diverse workforce

Pay: $115,000.00-$135,000.00 per year

Work Location: In person