Quality Assurance - Lindsay, Canada - Nipro Canada

Nipro Canada

Verified Company

Lindsay, Canada

2 weeks ago

Posted by:

Sophia Lee

beBee Recruiter

Description

Responsibilities:
Reporting to QA/RA Director, the role of QA/RA Associate is required to:

Monitor conformance to GMP under Quality System guidelines, compliance with ISO standards and adherence to organizational health/safety policies in the operational processes on a daily basis
Monitor the implementation of Standard Operation Procedure (SOP) and update the SOPs in collaboration with other functional departments as needed
Monitor and control materials and equipment such as returned product, packaging materials, sterilization supplies, environmental control supplies, supplies for testing and process validation, manufacturing equipment, sterilization equipment, and other calibration tools
Ensure full documentation on QA related issue throughout the operational procedure and full communication with all functional stakeholders
Work closely with R&D in identifying the needs of validation and perform the testing on operation process, materials or manufacturing equipment as needed.
Maintain and update documents such as QA files, QC inspection records, production batch records, sterilization records, validation documentation, supplier notification, internal change notification, customer complaint history, and testing/validation reports
Participate and support documentation for the regulatory audit, internal audit, management reviews, and supplier evaluation meetings Support and prepare QA compliance documentation for export and other customer inquiries
Perform other QA duties as required
Collect and coordinate information and prepare regulatory documentation for submission to regulatory agencies and advise on the submission strategy
Timely compile materials for license renewals, updates and registrations, responsible for timely registration of the facility
Maintain regulatory files/database and chronologies in good order. Establish and maintain system for tracking changes in documents submitted to agencies or partners
Review labeling and labels for compliance with regulatory requirements
Provide the regulatory reviews of customer complaints and define the regulatory reportability
Maintain current knowledge of HC, FDA and international regulation, guidance and standards applicable to company products
Actively participate in evaluation of regulatory compliance of document / product / process /test methods changes.
Participate in research of regulatory issues and dissemination regulatory information to Production, QA, QC and R&D departments and senior management as required
Other related duties as assigned

Qualifications:

Minimum progressive 3 years of QA/RA working experience in medical device manufacturing industry
University Degree/College Diploma in Biomedical engineering or science or QA/RA related field
Demonstrated experience in ISO9001 and internal QA audit
Expertise in ISO13485, HC, FDA, and EU MDR 2017/745 are preferred
Experience with regulatory submission in jurisdictions like HC, FDA etc.
Advanced computer skills with Microsoft Office Suite

Required Skills:

Excellent verbal and written communication skills, especially report writing skills
Strong organization and time management skills
Resultoriented, experienced QA professional that is auditready
Selfstarter and effective learner
Excellent understanding of environment control parameter, engineering drawing, and configuration, regulatory procedures
Must be detailorientated, problemsolving and analytical
Must be able to work both independently and in a team environment
Previous experience with sterilization equipment is highly preferred
Proven Ability to multitask and maintain procedure integrity
Demonstrated Ability to follow and enforce procedures
High level of math skills
Ability to identify and suggest continuous improvement
Positive attitude towards changes
Ability to work under pressure and other intense deadlines

Nipro Canada provides equal opportunity to all applicants. Accommodations for individuals with disabilities will be provided upon request at any stage of the recruitment and selection process.

Job Types:
Full-time, Permanent

Benefits: