Quality Assurance Manager

COLTENE is a global leader in the development, manufacture and sale of consumables and small-size equipment for dental treatment applications. We currently have an opening for a Quality Assurance Manager to join our team.

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 also establish performance standards, procedures, and audit controls in order to meet business requirements, as well as identify 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 Assurance Department personnel, resolution of product issues, and customer support, as well as the coordination of the company’s Quality Management System in the role of Management Quality Representative.

Duties:

• Perform Supplier qualification and evaluations (ISO certificates, quality infrastructure).
• Provide input to design and development activities.
• Provide input to manufacturing activities.
• Provide input to Materials staff on supplier selection criteria.
• Provide input to Business Unit platform meetings.
• Provide input on product certification related issues.
• Oversee and facilitate safety test house follow-up inspection audits of SciCan's production facility.
• Oversee incoming inspection, in-process inspection, final inspection activities.
• Perform statistical analysis of products and services.
• Perform statistical analysis of field data.
• Perform statistical analysis of 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 through regular quality control checks and by monitoring production failures and customer complaints and engaging with R&D, Production, IE, BU, etc. to resolve issues in a timely manner.
• Coordinate root cause analysis (RCA) meetings with team members and identify and implement solutions.
• Oversee metrology for all tool, jigs and fixtures.
• Develop and implement continual improvement programs.
• Review, disposition and approval of customer complaints.
• Oversee CAPA program.
• 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
• Perform Management Quality Representative Duties, including;
• 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.
• Act as liaison to notified body and other external certification bodies.
• Provide direction and feedback to executive/management team on quality programs and initiatives.
• Provide direction and guidance to all staff on quality programs, companywide.
• 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.
• Review and approval of Internal Audit program.
• Review approval of CAPA's resulting from all internal audits.
• Chair yearly QMS Management Review.
• Drive quality awareness program through companywide training.
• 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 & write Quality Plans and Process Validation reports for SciCan manufactured products.
• Conduct process validation activities for SciCan manufactured products.
• Review Technical files to ensure adherence to ISO 13485 requirements (Input/output, verification /validation, design reviews

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.·
• 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, and quality plans.
• Highly motivated and self-directed capable of multi-tasking, and able to work with minimal supervision.
• Extremely detail-oriented and analytical thinker.
• Able to interface directly with cross-functional teams.
• Ability to create and review technical documentation, including project plans, test procedures, and design documents.
• Able to develop, review, and maintain metrics and quality audits.
• Strong problem identification and problem resolution skills.
• High level of proficiency with computer system; MS Office, Visio, PLM & ERP (SAP preferred).
• A well-defined sense of diplomacy, including solid negotiation, conflict resolution, and people management skills.
• Able to build and maintain lasting relationships with other departments, key business partners, and government agencies.
• Strong work ethic and positive team attitude.

Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.

Interested candidates , please email a copy of your resume to : hr@scican.com

We thank all candidates for their interest in Coltene-SciCan. Candidates that meet the above requirements will be contacted for an interview. No phone calls please.

We offer : Competitive compensation, comprehensive Benefit & Pension program, continuing education reimbursement program, Fun & Positive team environment, a to name a few. You may learn more about Coltene-SciCan business and products by visiting our website at www.scican.com.

By applying and submitting your resume to our job posting, candidate acknowledges and confirms that the submitted resume is true and that the candidate is able to provide evidence of academic achievement or other information as required. You also confirm you are legally eligible to work in Canada.

Coltene-SciCan strongly believes that diversity in the workplace is essential to our success. We are an equal opportunity employer and we value diversity in its workforce, encouraging applications from all qualified individuals. Upon request by the applicant, accommodation will be provided in all parts of the hiring process.