Hybrid Senior Quality Control Manager

at PolyNovo Limited

• Job title: Senior Quality Control Manager
• Job type: Full Time
• Experience level: Senior
• Salary: Not specified
• Degree requirement: Bachelor's Degree
• Location requirements: Hybrid, Port Melbourne, Australia

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