Quality Systems & Regulatory Affairs Administrator

GlobalMed inc

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Main functions:

The Quality Systems & Regulatory Affairs Administrator is responsible for reviewing, updating, implementing, and maintaining the Quality Management System along with administering documentation control. This position deploys the development of quality documents and activities to assure our Quality System is accurate, functional and correct with other Systems within the organization.

Subject matter expert in all areas of quality documentation, i.e. Change Management, Corrective & preventative actions and non-conformances. Providingexpertise and guidance in interpreting governmental regulations, and internal policies to ensure compliance and effectiveness of processes and systems. Ensure that our organization is compliant to regulatory requirements as per our Quality Management Systems standards i.e. ISO 13485, FDA (510K)

Duties:

Implement, update, communicate and maintain a quality system that reflects the organization’s Quality and Regulatory policies and compliant with national and international standards. Develop and implement short- and long-term regulatory and documentation quality goals. Assist in planning and implementation of projects to meet Environmental and Quality ISO compliance objectives.

Support the management of Quality Systems documents including, Change Management, SOPs, Work Instructions, Training materials and other documents, as needed. Support the Quality team with administrative tasks to support Quality Management Systems (QMS)- Scan and archive documents.

Establish and maintain with senior management team, companywide quality assurance priorities, key objectives and compliance to regulations and the Quality Management System.

Ensure reliable document and document risk management; create programs to support a reliable process. Champion in PDM software and implementation. Preparation of documentation for above. Learn current Quality training tracking process administration.

Assist with development, implementation, auditing and maintenance of the QMS statutory and regulatory requirements. Maintain current internal auditing program to ensure compliance to ISO 13485

Validate quality system by completing company, system, compliance, and lead internal surveillance audit program; collaborating with other members of management to develop new product and engineering designs.

Prepare for, and actively support and participate in, external audits (customer & regulatory) and internal audits ensuring corrective/preventative actions are put in place to address identified non-conformances. Assist with the development of audit plans and follow-up on audit activities.

Follow-up and track completion of corrective actions to audit findings and nonconformances with responsible departments.

Lead in the creation and maintenance of Company documentation, such as, but not limited to process flow diagrams, forms, and prescribing documentation.

Ensure all Quality environmental sampling, monitoring, reporting and record retention is successfully completed and all compliance requirements are met through organizational and procedural measures.

With Human Resource team create and provide comprehensive Quality System and cGMP training to all employees.

Working conditions:

Office and production floor environment, computer and desk work as required.

Employment and Educational Requirements:

4 + years of Quality Systems hands on experience preferably within Medical Device manufacturing or Pharmaceutical Industry.

Experience with cGMP, FDA and ISO requirements and standards (ISO 13485)

Appropriate education, training and working experience in use of QA methodologies with a strong understanding of the principals of change control and document control.

Practical experience with risk management, capability studies, and control plans. Maintains Professional, Regulatory and Technical Knowledge by attending educational workshops; reviewing professional publications to ensure you remain current to organizational Quality standards.

Excellent understanding and ability in Advanced Product Quality Planning (APQP) , Process and product Failure Mode and Effects Analysis (FMEA), Gage R&R, Production Part Approval Process (PPAP) and Change Management.

Excellent technical writing and verbal communication skills, with the ability to present information and data in a clear and organized manner to a variety of audiences. Strong procedural and technical writing skills.

You need to be someone who is hands on in all areas of the role. Your understanding and use of MS Office Suite such as Excel, Word, Outlook,PowerPoint is excellent to expert. Possess strong self-motivation, organization, and prioritization skills. Must have strong grasp of English language written, verbal, technical and conversational.

*** This is not a remote, or hybrid position, all applicants must be able to work out of our Quinte West Ontario facility. ***

**Our organization is committed to creating a diverse environment and to be an equal opportunity employer. We will provide reasonable accommodation for disabilities to support the participation of candidates in all aspects of the recruitment process when requested. Only qualified applicants under consideration will be contacted for an interview.

Job Type: Full-time

Benefits:

  • Dental care
  • Extended health care
  • RRSP match
  • Vision care

Schedule:

  • 8 hour shift
  • Day shift

Supplemental pay types:

  • Bonus pay

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