Medical Device Quality Assurance jobs

Location Country

Australia

Vacancy Name

Quality Assurance Manager

Vacancy No

VN411

Employment Type

Full-Time

Duration

Division

Quality

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

Currency

AUD

Salary Minimum

$100,000.00

Salary Maximum

$140,000.00

Salary Period

Per Annum

Benefits