Sr. Associate I, Quality Assurance

4 weeks ago

Sydney, New South Wales, Australia Alcon Full time

At Alcon, we're passionate about enhancing sight and helping people see brilliantly. With more than 25,000 associates, we innovate fearlessly, champion progress, and act swiftly to impact global eye health. We foster an inclusive culture, recognizing your contributions and offering opportunities to grow your career like never before. Together, we make a difference in the lives of our patients and customers. Are you ready to join us?

Key Responsibilities:

  • Manage assessment of all complaints received in Australia and New Zealand for reportability to local regulators (TGA & Medsafe)
  • Coordinate responses to regulator questions regarding post market activities
  • Coordinate return of complaint samples, including facilitating replacement or refund, as applicable Provide support with submission and tracking of product complaints, as required
  • Perform reconciliation activities for customer-oriented programs, as required
  • Support improvement projects across the RAQA function Support of key regulatory activities for medical devices including; preparation of submissions to regulatory authorities, both for Australia & New Zealand, processing requests for certificates of free sale, responding to internal requests for registration information, management of reporting requirements for product supplied under the TGA Special Access Scheme and promotional material review Co-ordination of CPDS tracking and maintenance, as required
  • Maintenance of Registration Master File & submission of required paperwork to Global RA Managing licenses and permit requests, as required
  • Fulfil role of certified investigator for local CAPAs

Education: University degree in Science, Pharmacy, Engineering or related discipline

Skills & Experiences:
  • 3-5 years' experience working in a similar role for a medical device company.
  • knowledge of Regulatory requirements in ANZ and ISO standards relating to Quality Management Systems (i.e. ISO 13485 & ISO 9001).
  • Good written and verbal communication skills.
  • Strong knowledge of MS Office packages (e.g. Excel, Outlook, Word, Powerpoint)
  • Good work ethics with continuous improvements mindset

How You Can Thrive at Alcon:
  • Opportunity to work with a leading global medical device company.
  • Collaborate with a diverse and talented team in a supportive work environment.
  • Competitive compensation package and comprehensive benefits.
  • Continuous learning and development opportunities.

Alcon Careers

See your impact at alcon.com/careers

ALCON IS AN EQUAL OPPORTUNITY EMPLOYER AND PARTICIPATES IN E-VERIFY

Alcon takes pride in maintaining a diverse environment and our policies are not to discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, gender identity, marital or veteran status, disability, or any other legally protected status. Alcon is also committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please send an email to alcon.recruitment@alcon.com and let us know the nature of your request and your contact information.

EQUAL EMPLOYMENT OPPORTUNITY POSTERS

If you'd like to view a copy of the Alcon's affirmative action plan or policy statement, please email alcon.er@alcon.com.

ATTENTION: Current Alcon Employee/Contingent Worker

If you are currently an active employee/contingent worker at Alcon, please click the appropriate link below to apply on the Internal Career site.

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