Quality Systems Specialist (Maternity Leave Replacement)

The Opportunity          

We are seeking a Quality Systems Specialist to join our Quality Assurance department. Working under general supervision, this role is heavily involved in the creation, review and approval of Synaptive’s procedures and work instructions. There are direct responsibilities for simplification projects, oversight and maintenance of records, including internal audit assist and CAPA specific tasks.   The ability to evaluate and manage risks, risk treatment planning, and monitoring the implementation of risk mitigations and to evaluate their effectiveness, all of which support the Synaptive Quality Management System.

This role will reside on the Quality System team, which has a mission to provide a compliant and effective Quality Management System (QMS) that helps Synaptive and its employees achieve their collective objectives.

What You’ll Do          

• Lead and supports Quality System Improvement projects
• Interact with other departments to develop a compliant quality system using industry best practices as a foundation
• Assist in document management activities such as creating and updating procedures, process flow diagrams and work instructions
• An active participant in the review of CAPA Tasks, including investigation, RCA, corrective and corrective action
• Responsible for identifying new QMS risks and risks mitigation of identified risks using Process Failure Modes and Effects Analysis
• Assist in the creation of internal audit plans and participate in internal/external QMS audits
• Identify risks and justify acceptable risks across the quality management system
• Perform routine quality control tasks required in medical device development, manufacturing, and servicing
• Administrative oversight of tool calibration activities
• The employee may perform other related duties as necessary to meet the ongoing needs of the organization

Qualifications

• Undergraduate degree in engineering, project management or equivalent experience
• MDSAP ISO 13485:2016 Internal Auditor Training
• Minimum 5-year experience working in a medical device regulated industry

Beneficial

• Experience with configuration management of Product Lifecycle Management Systems (Fusion preferred)
• Previous Quality Assurance experience in the medical device industry
• Knowledge of 21 CFR 820, ISO13485:2016, MDSAP and ISO 14971
   

Interpersonal Skills

• Committed to work collaboratively as part of a team
• Willing to pivot and adapt to new strategies, processes, tools, and business/regulatory requirements
• Able to engage in active listening and to communicate clearly and effectively
• Receptive of constructive feedback and able to strive for continuous improvement
• Self-motivated and self-managing Special Requirements/Conditions
   

About You

• Self-motivated and results oriented
• Commitment to work collaboratively with colleagues towards team objectives, in-line with guiding principles
• Enthusiasm towards learning new methodologies of working, which may involve shedding habits
• Communication of intent to support decision-making and team alignment
• Perceptiveness of emotional intelligence, and employment of active listening skills
• Resourcefulness to research topics or investigate issues without instructions
• Cooperation when new strategies, processes, tools, and business/regulatory requirements require adaptation
• Responsiveness to constructive feedback by striving for continuous improvement

The Fine Print

The employee may perform other related duties as necessary to meet the ongoing needs of the organization.

Synaptive Medical is an equal opportunity employer and welcomes applications from all qualified individuals, including visible minorities, Indigenous People, and persons with disabilities.

We would like to thank everyone who submits a resume for these positions. Due to the volume that we receive, only those candidates selected for interviews will be contacted.