Location Country
Australia
Vacancy Name
Quality Assurance Manager
Employment Type
Full-Time
Summary of Role
Ensuring the quality, legal and regulatory compliance of SDI products throughout their lifecycle, from design and development to manufacturing to distribution.
Overseeing the implementation and maintenance of a robust quality system (QMS) in accordance with current standards, best practices, legal and regulatory requirements such as ISO 13485, MDSAP, EU MDR, QMSR (US), ARGMD (AU), ANVISA MD Regulations (Brazil), KGMP & MDM&QC standards (South Korea), NMPA’s Decree 739 Regulation on Supervision and Management of Medical Devices (China), SOR/98-282 (Health Canada), PMD Act (Japan) etc.
Accomplishing quality assurance objectives by monitoring, reviewing, and enforcing policies and procedures.
Contributing to the development and implementation of Quality systems, policies and strategies.
Contributing towards SDI Strategic Priorities.
Conducting work in a safe manner, adhering to quality compliance requirements and demonstrating a strong commitment to SDI's values of passion, accountability, respect, teamwork, and innovation.
Specific Responsibilites
Leads, coordinates, and plans the work within the QA team
Coaches and leads QA Team to develop adequate competencies, efficient working methods, optimal use of resources and a stimulating working climate.
Maintains accurate up-to-date documentation related to SDI’s QMS, including procedures, records, and reports.
Provides Quality Assurance input throughout the product development process to ensure quality is built into the design.
Implements risk management systems and processes to identify and mitigate potential risks and product quality and safety.
Implements and conducts internal audit programs to identify areas for improvement.
Prepares for inspections/audits by regulators.
Working with R&D, Engineering, Manufacturing and Marketing to ensure that quality is integrated into all aspect of the product lifecycle.
Oversees and ensures the following QA activities are up to date, maintained, analysed, trended and reported into Management regularly:
o Customer complaints handling and reporting
o NCR
o CAPA
o Training
o Change control
o Internal audits
o Supplier & Subcontractor audits
o External (3rd party) audits
o Subsidiary audits
o QMS Documentation
o Post Market Surveillance (PMS)
Assists validation activities across various departments such as Production, R&D and Engineering
Works with Procurement with supplier qualification and evaluation
Contributes to Quality strategies for Continuous Improvement across the business
Collaborates with the Quality Control Manager to train and motivate employees to ensure quality standards are met
Achieves quality assurance operational objectives by contributing to information analysis
Stays current on applicable laws and regulations to ensure compliance
Acts as internal (outside the EU) Person of Responsibility for Regulatory Requirements (PRRC). Key responsibilities of this PRRC include:
o Reviews and approves the conformity assessment of the device’s technical documentation before market release.
o Ensuring that the device being released from routine manufacturing have been manufactured in accordance with SDI’s QMS procedures and QC release criteria are traceable to the device specification.
o Conducts periodic sampling of batch release documentation.
The PRRC shall suffer no disadvantage within the business in relation to the proper fulfilment of their duties.
Supports Top Management in the promotion of SDI Quality policy and objectives.
Oversees and ensures the following QA activities are up to date, maintained, analysed, trended and reported into Management regularly:
o Customer complaints handling and reporting
o NCR
o CAPA
o Training
o Change control
o Internal audits
o Supplier & Subcontractor audits
o External (3rd party) audits
o Subsidiary audits
o QMS Documentation
o Post Market Surveillance (PMS)
Assists validation activities across various departments such as Production, R&D and Engineering
Works with Procurement with supplier qualification and evaluation
Contributes to Quality strategies for Continuous Improvement across the business
Collaborates with the Quality Control Manager to train and motivate employees to ensure quality standards are met
Achieves quality assurance operational objectives by contributing to information analysis
Stays current on applicable laws and regulations to ensure compliance
Acts as internal (outside the EU) Person of Responsibility for Regulatory Requirements (PRRC). Key responsibilities of this PRRC include:
o Reviews and approves the conformity assessment of the device’s technical documentation before market release.
o Ensuring that the device being released from routine manufacturing have been manufactured in accordance with SDI’s QMS procedures and QC release criteria are traceable to the device specification.
o Conducts periodic sampling of batch release documentation.
The PRRC shall suffer no disadvantage within the business in relation to the proper fulfilment of their duties.
Supports Top Management in the promotion of SDI Quality policy and objectives.
Drives a thorough understanding of current Quality policies and objectives throughout the Company
Key Relationships (Internal & External)
All key SDI personnel
External suppliers, contractors and consultants
Regulatory auditors such as TGA, DQS, CSA, Inmetro, UL etc
Job Environment
Position is located at Bayswater Head Office
Working hours: 10-day fortnight
Local, interstate and international travel as required.
Education Level
Bachelor's Degree
Essential Experience
Aware of SDI’s current Quality policy and objectives
Strong working knowledge of ISO13485, MDSAP, EU MDR, 21 CRF, SOR/98-282, Regulation (EC) No 1223/2009, FDA MoCRA, IEC 60601-1 etc.
Strong understanding of MDR post-market surveillance requirements (Article 83 to 86) and any additional non-EU country specific requirements
Experience with audit processes
Knowledge of quality management systems.
Experience in enforcing Quality requirements within the business.
Experience in motivating, training and monitoring staff performance.
Knowledge and skills
Aware of SDI’s current Quality policy and objectives
Personal Qualities
Clearly understands the role of Quality in supporting customer service.
Sense of urgency and commitment for achieving agreed and challenging targets.
Identify and implement innovative ideas.
Identify and address short and long solutions to production problems.
Understands the Quality and Safety requirements in the production environment.
Classification Level
Non-Award
Salary Minimum
$100,000.00
Salary Maximum
$140,000.00
