Job Summary

Reporting to the Supply Chain and Business Intelligence manager, the Production Scheduler will assist the operations team by scheduling the production of manufactured equipment & spare parts, developing SAP training manuals, and completing spreadsheet analysis during issue resolution and planning scenarios.

Core Competencies:

• Communication
• Customer Focus
• Computer Skills
• Teaching and Educating
• Autonomy
• Continuous Learning
• Teamwork
• Time Management
• Accountability and Dependability
• Ethics and Integrity

ECO key Responsibilities:

• Efficiently process and implement new or revised ECOs on the SAP system.
• Ensure compliance with specified conditions outlined by the R&D department.
• Manage changes to implementation dates, revision numbers, Bill of Materials (BOMs), and material master settings for raw materials, assemblies, finished products, and associated documents.
• Release ECOs through Q-Pulse, SharePoint/MasterLog, and compile a final ECO PDF file incorporating all required worksheets, drawings, and email confirmations from relevant departments.
• Update Engineering Change Request (ECR) and ECO status in the MasterLog (ECR/ECO Database) workspace.
• Archive and release drawings and files as per the specifications outlined in the ECO form.
• Ensure compliance with regulatory and internal requirements.
• Create Q-Pulse Actions as necessary for individuals involved in the ECO implementation process, aligning with ECO requirement conditions.
• Send timely and accurate emails to the ECO Distribution List, outlining actions to be taken by members based on their areas of expertise.

Educational and Experience Requirements:

• Bachelor’s degree in industrial engineering, Business, Finance, Data Analytics, or related field.
• APICS supply chain training certifications is considered an asset.
• Proficient in Microsoft Office
• Advanced level in PowerPoint and Excel
• Proven experience in production scheduling or a related administrative role.
• Strong organizational and time-management skills.
• Excellent communication and interpersonal abilities.
• Proficient in using production management software and Microsoft Office Suite.

Preferred Skills:

• Knowledge of lean manufacturing principles.
• Familiarity with industry-specific production processes.
• Experience with ERP (Enterprise Resource Planning) systems such as SAP.

Job Summary

The Quality Assurance (QA) Manager ensures that quality standards and policies &procedures are upheld and aligned with regulations and customer specifications. This individual is responsible for managing the organizations quality assurance programs and being directly involved in the new product development processes. The QA Manager will help establish and implement process improvements to increase the efficiency, effectiveness, and quality of the company’s operations and products. Other responsibilities will include the supervision of the Quality Department personnel, leading product quality improvement initiatives, supporting customers’ needs, and overseeing the company’s Quality Management System in the role of Management Quality Representative.

Job Duties & Responsibilities:

• Perform Supplier audits, qualification and evaluations.
• Provide input to design and development activities, manufacturing, Materials staff on supplier selection criteria, Business Unit platform meetings, and product certification related issues.
• Oversee and facilitate safety test house inspection audits of SciCan’s production facility.
• Oversee incoming inspection, in-process inspection, and final inspection activities.
• Perform statistical analysis of products and services, field data, and supplier performance.
• Assess and test parts returned from the field to determine/validate defect types and assess correlation to in-house failures.
• Drive manufacturing product quality improvements through regular quality control checks, monitoring production failures and customer complaints and engaging with R&D, Production, IE, BU, etc. to resolve issues in a timely manner.
• Drive quality awareness throughout the company and coordinate and lead product quality improvement initiatives with team members and identify root cause(s) and implement solutions and KPIs.
• Develop and implement continual improvement programs.
• Oversee metrology for all tool, jigs and fixtures.
• Review, disposition and approval of customer complaints.
• Monitor and assess monthly complaint reporting and report to management trends and actions.
• Provide leadership developing and directing QA/QC personnel and identify relevant training needs.
• Develop and manage departmental budget.
• Provide direction, guidance, and feedback to all staff, and senior management team on quality programs and initiatives.
• Review and approval of Internal Audit program.
• Review approval of CAPA’s resulting from all audits.
• Oversee CAPA program.
• Provide guidance to Sci Can on development of procedures and processes as they relate to the quality management system companywide.
• Work with Industrial Engineering to develop process validation plans.
• Develop Quality Plans and Process Validation reports for SciCan manufactured products and perform process validation activities.
• Review Technical files to ensure adherence to ISO 13485 requirements (Input/output, verification /validation, design reviews)
• Act as liaison to notified body and other external certification bodies.
• Maintain SciCan’s ISO 13485 certification, and all other required standards.
• Oversee/facilitate external audits to ISO standards, FDA Inspections, Health Canada Inspections, Foreign inspections, etc.
• Perform Management Quality Representative Duties, including:
• Chair yearly QMS Management Review
• Sign-off authority for changes to procedures, processes, design (delegated), etc.
• Authority to act on behalf of top management during the audit
• Authority to place products or processes on hold.
• Responsibility for managing quality audit functions (delegated).
• Responsibility for contributing to corrective and preventive action activities, complaint handling and the handling of nonconforming product, etc.

Educational and Experience Requirements:

• Degree in Quality Engineering or Engineering Degree plus Quality Certificate.
• Minimum of 5-10 years of experience dealing with quality management systems, regulations, guidelines and associated standards preferably in a Medical Device manufacturing environment preferably with technology related products.
• Knowledge and experience in ISO 13485, MDSAP required; MDR experience is an asset.
• Demonstrated experience in taking companies through required quality management certification processes and audits as the MQR.
• Management of staff in various disciplines in quality management.
• Experience in training and developing personnel at all levels in quality management.
• Must possess excellent communication skills for liaising and communicating with suppliers, customers, auditing bodies, and internal departments.
• Proven ability to deliver presentations and training, effectively and efficiently with clear communication skills and delivery.
• Practical experience with risk management, product testing, capability studies, GD&T, and quality plans.
• Ability to create and review technical documentation, including project plans, test procedures, and design documents.
• High level of proficiency with computer system; MS Office, Visio, PLM & ERP (SAP preferred).

Job Summary

We are looking for an experienced Senior Project Manager who will lead the project management team globally and guide teams through large, complex project activities, while adhering to the PMO standards, processes, and methodologies.

Core Competencies:

• Communication
• Customer Focus
• Computer Skills
• Teaching and Educating
• Autonomy
• Continuous Learning
• Teamwork
• Time Management
• Accountability and Dependability
• Ethics and Integrity

Job Duties & Responsibilities:

• Lead Global Project Management Team
• Develop detailed project plans, timelines, and budgets
• Develop harmonized policies, procedures and instruction for the organization and its sites
• Develop project related KPIs
• Monitor project performance and share via dashboards or reports
• Coordinate internal resources and third parties/vendors for the flawless execution of projects
• Work with functional managers maximize resource utilization using resource management and capacity planning tools
• Deliver projects on-time, within scope, and within budget

Requirements:

• Bachelor’s degree in business, management, engineering or a related field
• Proven working experience 8-10 years, in project management and different methodologies
• Project Management Professional (PMP) certification is a plus
• Experience with Agile / Scrum / Kanban, certification is a plus
• Experience managing IT /Business projects like integrating ERP, PLM or CRM applications
• Experience management product development projects, required
• Experience management Technology and Software projects, desired
• Experience working in a regulated environment, eg medical devices, aviation, military, is a plus
• Excellent written and verbal communication skills
• Solid organizational skills including attention to detail and multitasking skills
• Strong working knowledge of Microsoft Office, MS Teams, etc, required
• Expertise with project management tools, like MS Project, OnePlan, required
• Experience with agile and software management tools like Atlassian JIRA, required
• Experience working in an Agile development process
• Excellent attention to detail
• Excellent analytical and problem-solving skills
• An excellent team player who can work efficiently with minimal supervision
• Solid organizational skill and demonstrated initiative
• Have excellent oral and written communication skills