Quality Assurance Specialist

at  Southmedic Inc

Southmedic is known globally as an innovative, high quality Canadian medical device manufacturer. At Southmedic you will enjoy an open-minded culture that fosters individual growth and career development within a dynamic team. Southmedic believes in continually investing in our staff; allowing you to reach your full potential through ongoing training and development. You will engage with a team that values respect, accountability, and integrity.
We are looking for a Quality Assurance Specialist – a skilled individual who will champion corrective and preventative action teams for customer, supplier and internal non conformances. The Quality Specialist will provide Quality Engineering support for both proprietary products and contract manufacturing. The Quality Specialist will participate in risk mitigation activities and will analyze quality trends for continuous improvement opportunities. The Quality Specialist will support key departmental objectives and our quality management system.

WHAT WE NEED

• A minimum of two years of previous experience in a manufacturing environment working within a Quality Management System compliant to an ISO standard is required.
• Post-graduate education in Engineering, or Manufacturing, or Science-based or Business discipline and /or an acceptable combination of education, training and experience
• Experience in: customer service, root cause analysis, meeting management, time management, facilitation skills, and delegation skills.
• Previous leadership experience will be considered a benefit to this position.
• Should have or be working towards the Quality Certificate Program (QCP) in association with the American Society for Quality (ASQ).
• Attention to detail and the ability to multi task are key components to this position.

• Championing of the Complaint Handling and Corrective Action Process for tier 1 and tier 2
• Provide customer with feedback and updates as required to maintain customer confidence
• Document external non-conformances to the Quality Management System
• Ensure 100% on time customer response to customer complaints/feedback and CAPA’s
• Initial response within 3 days
• Closure target within 30 days (as outlined in SOP)
• Champion cross functional corrective action teams, for both internal and external non conformances, and promote the use of quality core tools for root cause analysis
• Update the Director of Quality with any issues as they arise that could affect customer satisfaction
• Provide Quality Engineering support to internal and external customers
• Member of the material review board
• Key member providing support to both Customer and Regulatory audits
• Member of the internal audit team
• Provide new launch support to Engineering from concept to production on both part and process
• Source new inspection gauges
• Play a leading role in risk mitigation activities such as FMEA
• Analyzing quality trends for continuous improvement opportunities
• Champion continuous improvement initiatives that place downward pressure on the cost of quality.
• Identify areas of opportunities within the Quality Management System (QMS) to support Southmedic’s key business objectives
• Take ownership of projects and work independently within a team environment to reach departmental and company goals
• Communicate clearly, effectively and professionally with customers, registrars, regulatory representatives, suppliers and within the Southmedic team
• Interface with co-workers in a courteous professional manner
• Administrative support to the Director of Quality and VP Quality & Regulatory Affairs
• Follow all applicable Southmedic policies, procedures and work instructions
• Provide backup support for Director of Quality
• All other projects and duties as assigned
• Maintain strict confidentiality with respect to pending documentation revision changes that could have an impact to current employees. This includes, changes to the Organizational Chart as well as changes to policies and procedures.
• Customer Satisfaction