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About the role
- Senior Quality Control Manager overseeing QC for innovative medical technology products. Leading compliance with ISO13485 and continuous improvement for quality and patient safety.
Responsibilities
- Lead and manage the QC team across incoming, in-process, and final product inspection and testing
- Maintain and update QC procedures, documentation, sampling plans and test methods
- Ensure all QC activities align with ISO13485, GMP, company and relevant regulatory authority requirements
- Lead development and implementation of GMP methods and procedures for inspecting, testing, and evaluating the identity, purity, and safety of raw materials, intermediates, and finished products
- Oversee QC laboratory operations, including test method validation, equipment validation, and environmental monitoring requirements
- Manage the investigation of non-conformances and out of specification occurrences
- Work closely with QA, Manufacturing, Engineering, Validation, R&D, Regulatory Affairs and Supply Chain to resolve quality issues as they arise
- Continuously optimise and improve QC procedures
- Lead, mentor, and develop QC staff to maintain a high level of technical competency and compliance within the team
Requirements
- Tertiary qualifications in Science (preferably Chemistry) or related discipline
- A minimum of five (5) years of relevant Quality Control experience in medical device or pharmaceutical manufacturing
- A background in Microbiology an advantage
- Experience in materials properties and polymer characterisation equipment an advantage
- Experience in and knowledge of manufacture of medical devices in a GMP environment, including audits
- Strong understanding of regulatory guidelines relevant to the role
- Minimum 2 years supervisory experience required
- Ability to exercise judgment within broadly defined practices and policies in selecting methods, techniques, and evaluation criteria for obtaining results
- Ability to analyse complex data to identify sources of variability or error and define corrective actions
- Excellent attention to detail
- Independence with efficient time management and organizational skills
- Excellent written and verbal communication skills
Benefits
- Dynamic work environment
- Career development opportunities
- Unlimited access to online learning
- Rewards platform with access to discounts at over 450+ Australian retailers
- Paid parental leave for primary and secondary carers
- Nurture Days
- Salary packaging including novated car leasing
Job title
Job type
Experience level
Salary
Not specified
Degree requirement
Location requirements
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