Quality Engineer Ii- Bh

Careers that change lives start here. Medtronic is a global leader in healthcare technology with a Mission to alleviate pain, restore health, and extend life. Our 95,000 employees work across more than 150 countries to put patients first — developing innovative medical technologies that improve the lives of 72+ million patients each year. Your unique talents will help shape the future of healthcare while building a career grounded in purpose, growth, and impact.
A Day in the LifeThe Quality Engineering function within Service and Repair is responsible for ensuring compliance, product quality, supplier quality technical support and continuous improvement across service center and field service operations. This team partners closely with Engineering, Regulatory, Supplier Quality, Post-Market Quality, and Operating Units to support quality system requirements, continuous improvement initiatives, supplier management, audit readiness, and the introduction and sustainment of products throughout the service lifecycle.
The Service & Repair Quality Engineer II provides quality engineering support for a global Service and Repair organization. This role partners cross-functionally to maintain compliance with quality system requirements, support daily operations, drive resolution of quality issues, support supplied products and processes, and ensure audit readiness across service center and field service activities. The Quality Engineer II also plays a key role in Corrective and Preventive Action (CAPA) activities, process validation efforts, and continuous improvement initiatives that support operational performance and product quality.
This role is based in Milton, Ontario and requires onsite presence
5
days per week to support manufacturing and service operations. Travel is expected to be 15% or less.
Primary Responsibilities:
Partner with Engineering, Supplier Quality, Design Quality, Regulatory, Post-Market Quality, and Operating Units to support quality system compliance and operational objectives.
Develop, implement, and maintain quality standards, procedures, and controls within a service and repair environment.
Provide quality oversight for validation and verification activities, nonconformance management, and Corrective and Preventive Action (CAPA) processes.
Investigate quality issues, assess risk, and support implementation of effective corrective actions.
Ensure that suppliers deliver quality parts, materials, and services.
Coordinate and monitor change control process (including review and approval) to ensure performance, compliance and regulatory requirements are met and properly documented.
Review/prepare test plans and reports (qualification, validation) for change and improvement activities (supplier certifications, material/sub-supplier changes and supplier performed special processes);
leveraging the Production Part Approval Process (PPAP) when required.
Conduct audit/assessment of current or future suppliers ensuring they are compliant with associated Medtronic policies and GMP/ISO requirements.
Monitor, analyze, and communicate quality metrics, performance trends, and improvement opportunities to stakeholders.
Lead quality walks, facilitate resolution of identified gaps, and track actions through completion.
Initiate, manage, and support Supplier Action Requests (SAR) and Supplier Corrective and Preventive Actions (SCAPA) in accordance with applicable procedures and escalation criteria.
Support internal and external audits by coordinating audit readiness activities and representing the service organization during audit interactions.
Contribute to continuous improvement initiatives across areas including incoming inspection, inventory control, production processes, product evaluation, and operational quality systems.
Required Qualifications:
Bachelor’s Degree in Engineering, Science, or a technical field with 2+ years of engineering and/or quality experience OR an Advanced Degree in Engineering, Science, or a technical field with 0+ years of engineering and/or quality experience.
Preferred Qualifications:
Quality System Lead Auditor experience (ISO 13485).
Working knowledge of ISO 14971 and medical device risk management principles.
Experience working in a regulated industry, preferably in the medical device industry.
Experience analyzing quality data, investigating issues, and supporting corrective action activities.
Experience in supplier quality processes (Supplier controls, process validation, failure investigation techniques, nonconforming product controls, and protocol/report generation.
Ability to collaborate effectively across multiple functions and organizational levels.
Experience supporting service, repair, manufacturing, or operations-focused quality activities.
Experience with Corrective and Preventive Action (CAPA), nonconformance management, and root cause investigation methodologies.
Experience with equipment/process validation and verification requirements.
Experience supporting internal or external audits in a regulated industry.
Familiarity with continuous improvement methodologies and quality performance metric reporting.
Salary range: $77,200 -$96,500
PHYSICAL JOB REQUIREMENTS
The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. For Office Roles: While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer and communicate with peers and co-workers.
Medtronic Canada strives through our vision to build a culture of inclusiveness through our commitment to employment equity and diversity. Discrimination is prohibited on any grounds protected under Canadian Human Rights legislation. Employment applications are encouraged from all members of our community. Upon request, candidates with disabilities will be accommodated during the recruitment process.
SPECIALIST CAREER STREAM:
Typically an individual contributor with responsibility in a professional discipline or specialty. Delivers and/or manages projects assigned and works with other stakeholders to achieve desired results. May act as a mentor to colleagues or may direct the work of other lower level professionals. The majority of time is spent delivering and overseeing the projects – from design to implementation - while and adhering to policies, using specialized knowledge and skills normally acquired through advanced education.
DIFFERENTIATING FACTORS
Autonomy:
Established and productive individual contributor.Works independently with general supervision on larger, moderately complex projects / assignments.
Organizational Impact:
Sets objectives for own job area to meet the objectives of projects and assignments.Contributes to the completion of project milestones .May have some involvement in cross functional assignments.
Innovation and Complexity:
Problems and issues faced are general, and may require understanding of broader set of issues or other job areas but typically are not complex .Makes adjustments or recommends enhancements in systems and processes to solve problems or improve effectiveness of job area.
Communication and Influence:
Communicates primarily and frequently with internal contacts .External interactions are less complex or problem solving in nature.Contacts others to share information, status, needs and issues in order to inform, gain input, and support decision-making.
Leadership and Talent Management:
May provide guidance and assistance to entry level professionals and / or employee in Support Career Stream
Physical Job Requirements
The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position.
Benefits & CompensationMedtronic offers a competitive Salary and flexible Benefits PackageA commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage.
This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP).
#J-18808-Ljbffr