Quality Assurance Coordinator

2 months ago

Markham, Canada Bayshore HealthCare Full time

**_DUTIES AND RESPONSIBILITIES_**
- Addresses concerns from clients, contract representatives in an effective and timely manner - working with relevant internal staff and external parties
- Ensures required data is collected and compiled for generation of required reports
- Ensures required reports are prepared and communicated to relevant parties
- Works with internal staff and management to ensure operations support meeting required contractual obligations
- Interfaces with internal staff to ensure Quality Management Reports are completed and addressed in a timely manner
- Manages internal requirements, contract adherence - deliverables, catalogue, protocols
- Adhere to DEX Medical Distribution Policies and Procedures.
- Periodically update Standard Operating Procedures as required
- Participate in quality activities and continuous improvement initiatives in keeping with the company's Quality Management System
- Responsible for internal auditing of processes and procedures in place
- Participates in proactive Health & Safety activities while performing all duties. Is responsible to notify immediate Supervisor of any Health & Safety risks or concerns. Responsible for completing Accident Reports for all direct reports who injure themselves on the job, within 24 hours of the incident.
- Work with staff, department heads, and management to document internal processes
- Become intimately involved with operations to develop a complete understanding of the environment and operating conditions involved, as well as the desired results. Communicate with external entities to ensure that internal processes may be inadequate to meet business needs.
- Flexible with participation of process improvements, changing process documentation as required.
- Obtain approval of all documented processes from the respective operational leave before review by the Director
- Maintains confidentiality of client and corporate information and discusses same only with appropriate DEX Medical Distribution personnel
- Review and adapt policies and procedures to adhere to GMP requirements
- Participate in ongoing internal and/or external continuing education activities such as GMP (Good Manufacturing Practices) training on an annual basis
- Participate in Recall Process, Investigating Complaints, Release Product, Review Temperature Records and Maintain Pest Records
- Maintain all other GMP and Quality Function Records
- Maintains confidentiality of client and corporate information and discusses same only with appropriate DEX Medical personnel
- Complete other tasks as requested

Job Qualification

**Qualifications**:

- Bio-Medical Engineering Diploma
- or
- Health Sciences Engineering
- or
- Quality Assurance Program ( ISO, SOP, GMP related programs)

**Experience**
- Previous experience working in Healthcare Field in a Quality role
- Experience working in a GMP regulated environment
- Knowledge of Medical Equipment an asset
- Excellent analytical, observation and problem-solving skills
- High sense of energy & urgency with a positive attitude
- Exemplary oral and written communication skills and written document skills

Bayshore is committed to a high quality and safe environment for both our staff and clients/patients. At Bayshore all new hires must have received the full series of a COVID-19 vaccine or combination of COVID-19 vaccines approved by Health Canada (e.g., two doses of a two dose vaccine series or one dose of a single
- dose vaccine series); AND have received the final dose of the COVID-19 vaccine at least 14 days prior to the official start date of hire. Medical exemptions or any other kinds of requested exemptions based upon Human Rights Code will be considered on a case-by-case basis.

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