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 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.

Core Competencies :

Strong communication skills

Planning and Organizing

Teamwork

Problem Solving and Analytical skills

Quality Oriented

Result Focused

Adaptability / Flexibility

Accountability and Dependability

Creative and Innovative Thinking

Ethics and Integrity

Decision Making and Judgement

Mediating and Negotiating

Development and Continual Learning

Staff Management, Coaching / Mentoring

Leadership

Enforcing Laws, Rules and Regulations

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 specific departments : R&D, Production, Industrial Engineering, Business Unit, 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.
• Oversee CAPA program, Review approval of CAPA's resulting from all audits
• 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 :

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 :

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

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.