Job Description

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Quality and Regulatory Officer

Advertiser: Canterbury Scientific LimitedMore jobs from this company

Job Information

Job Listing Date
3 Jul 2019
Location
Canterbury, Christchurch
Work Type
Full Time
Classification
Science & Technology, Quality Assurance & Control

About the business

Canterbury Scientific Ltd is a globally recognised supplier of IVD products. They manufacture a range of human blood protein based medical device products for the global diagnostic sector. From their modern, purpose-built site in Christchurch, incorporating well integrated Design & Development and manufacturing laboratories and facilities, they are continuing to lead their specialist field. The Company has a commitment to providing high quality products, which have been designed, developed and manufactured according to sound scientific principles.

About the role

Reporting to the Quality Manager and working as part of a team, you will be responsible for the following,

Manage Quality Management System activities: 

Ensure that QMS within the company is implemented, reviewed, followed and any changes aptly communicated to everyone.

Operate the Company's quality systems to ISO standards and FDA regulations as mentioned above. In doing so, also ensure that all customer requirements are met.

NCR and Change Control Coordinator.

Management of customer complaints, feedback and inquiries.

Drive Risk Management.

Backup Document Controller.

Review and approving Batch Manufacturing Records.

Issuing of Certificate of Analysis (CoA's).

Final product documentation approval prior to shipping release.

Manage supplier qualification process.

Internal / External Audits

Manage internal audits of the Quality Management System.

Assist with all external audits like certification, regulatory and customer audits.

Regulatory Affairs

Maintaining CE Marked Technical Files for our products.

Assist with the preparation and review of regulatory submissions required for product approval.

Maintain external certification/representation.

Provide advice and guidance on regulatory compliance and risk issues.

Ensure that all compliance requirements are met.

Keep management informed of significant regulatory changes that may impact the business.

Supporting customers in device registration activities.

Job benefits

A competitive salary package

Opportunity to learn and grow with the company

Close to shops and restaurants

Parking on site

What will allow you to succeed

A tertiary qualification in Science is a must.

Previous experience in a Biotech / Medical Device / Pharmaceutical / Manufacturing industry is required.

Strong Quality Management background.

Experience with Quality ISO standards, preferably ISO 13485, ISO 14971 and FDA regulations.

Solid internal and external auditing experience.

Good understanding of risk management.

High level of accuracy and attention to details.

A positive attitude, willingness to learn and passion for process improvement.

The application form will include these questions:
  • Which of the following statements best describes your right to work in New Zealand?
  • What's your expected annual base salary?
  • How many years' experience do you have in a quality assurance (QA) role?
  • Have you completed a qualification in science?
  • How many years' experience do you have in a quality control (QC) role?

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