Manager, Quality Assurance, Oceania

Summary about this job

Detail information about job Manager, Quality Assurance, Oceania. Terms and conditions vacancy

Merit Medical Australia Pty. Ltd. is responsible for the manufacture, and sterilization of Custom Procedure Packs, Surgical Drapes, and Gowns. In addition to this Merit Medical Australia Pty. Ltd. distributes these, and other medical devices produced by sister companies to the Oceania Market, is based in Chelsea Heights, Victoria, and currently employees 60 persons.

 SUMMARY OF DUTIES

Develops, interprets, and implements quality policies, manages quality systems, and facilitates compliance at the respective site and/or region. Assigned site Quality System Management Representative; primary regulatory agency and customer contact on all quality related queries e.g. compliance audit & follow up, customer complaints, quality agreements, and technical agreements. Works in close collaboration and partnership with Global Quality Assurance Team, other divisions, departments, and functions, to optimize overall operational efficiency and effectiveness while maintaining & developing best in class quality systems.
Multiple Manager, Quality Assurance may be part of the organization concurrently. For specific duties, refer to current organization charts of the Quality Assurance Department, within site and/or region.

ESSENTIAL FUNCTIONS PERFORMED
Takes ultimate responsibility for the direction and effective management of assigned departments within the quality assurance function, ensuring that each department is resourced, structured and managed to support the goals of the organization. Departments may include, but not limited to: 
 

• Calibration
• Compliance
• Design Assurance
• Field Assurance
• Internal/External Quality Audit
• Management Review
• Quality Engineering
• Sterilization
• Validation (Product & Process)
• CAPA
• Document & Data Control
• Environmental Control
• Risk Management
• Quality Control, Product Release
• Quality Inspections
• Real-time Aging
• Supplier Quality

1. May be assigned Quality System Management Representative for Merit Medical Systems Inc at the site and/or region; may be primary regulatory agency and customer contact on all quality related queries for the site e.g. compliance audits & follow up, customer complaints, quality agreements, and technical agreements.

2. Provides input regarding Quality Assurance Program strategy for the site and/or region and meets the required regulations applicable to the processes managed, products produced, and global markets served e.g. US, South America, Canada, EMEA, APAC, Oceania CSR (Customer Specific Requirements), etc.

3. A key member of Senior Leadership Team that manages, develops and drives Merit Medical Systems Inc. to deliver the goals of the business i.e. Best In Class (Safety, Quality, Business Processes), Revenue Growth & New Business Development.

4. Promote, support the "Merit Business Excellence System" Program; lead by example; partner with functional leaders to ensure that this program, the organization's objectives and values are at the forefront of decision making and action.

5. Identifies opportunities to improve organizational systems and processes to save costs, improve efficiency, maintain compliance, increase the value of products, or increase customer satisfaction.

6. Develops capital plans and budgets for the Quality Assurance Department.

7. Provides Merit Medical Systems Inc. with recommendations and decisions which uphold company and regulatory standards in furnishing quality products to the customer by:

• Developing and directing annual 'Quality Assurance" team goals to deliver the key company objectives and continuous growth of personnel.
• Reviewing performance of Quality Assurance staff in achieving compliance and system improvement objectives.
• Preparing or reviewing written procedures and documentation for testing and manufacturing processes.
• Tracking information about customer complaints to provide design, development and operations teams with product quality information.
• Providing recommendations and decisions regarding the disposition of non-conforming products; determines when Regulatory/Clinical approval is required; stops production lines if problems with quality arise and initiate preventive and corrective actions to ensure non-recurrence.
• Coordinating Emergency Management Team (EMT) meetings and participates/manages product investigations.

8. Provides technical support for the manufacture of existing products and the growth and development/transfer of new products/technologies.

9. Partner with Research and Development (Product & Technology) function ensuring:

• Customer requirements are met
• Safe and effective product design
• Compliance with design control requirement
• Design for manufacture
• Quality at source
• A smooth transition of new products and Technologies to operations groups

10. Participate, support and provide an independent review of all verification and validation activities.

11. Functional manager for a team of quality assurance personnel:

• Resource functional areas projects with the required resources.
• Select, coordinate assigned work, mentor, manage performance for all team members ensuring appropriate corrective action for sub-optimal performance, and recognition of strong performance creating avenues for advancement.
• Manage training and career development needs of the team to the benefit of the individuals and the organization, ensuring that talent is positioned and utilized for maximum effectiveness

12. Perform other related tasks as required.

SUMMARY OF MINIMUM QUALIFICATIONS 

• Education and/or experience equivalent to a Bachelor's Degree in Quality Engineering/Engineering/ Science, or equivalent qualification essential (NFQ Level 7, or higher).
• At least nine years of work-related experience, of which a minimum of four years' experience in a related management role.
• Proven track record in leading organizations through external inspections/audits (e.g. FDA, Notified Bodies, Regulatory Agencies, Competent Authorities, and Customers).
• Working knowledge of and experience with U.S. FDA regulations, the Medical Devices Directive (93/42/EEC), ISO 13485 Quality System Standard, ISO 14971 Risk Management, Canadian Medical Device Regulation (CMDR), ANVISA, TGA and JPAL/JGMP.
• General knowledge of the medical device industry and the applications of Merit's products in the medical field.
• PC skills including standard offices packages as well as ability to understand and learn customized computer software programs.
• Excellent communications skills to include oral and written fluency in English and local language as deemed appropriate.

PREFERRED QUALIFICATIONS

• Postgraduate diploma/master's degree in Quality Management.
• Demonstrated aptitude for process improvement and use of Lean and Six-Sigma resources and tools.
• Strongly prefer medical device manufacturing management experience.
• Strongly prefer proven track record leadership experience in the development of a large, international team, in multiple regions.

COMPETENCIES / EXPECTATIONS

• Strong leadership ability and the ability to influence at all levels within the organization.
• Demonstrated leadership skills including the ability to coach, assess, evaluate, develop, motivate and empower others.
• Ability to provide functional, cross-functional and organizational leadership as required by the demands of the role.
• Excellent communication (oral and written) and interpersonal skills with the ability to convey information and ideas in a variety of media, tactful, confident at all levels, internal and external.
• Excellent data, analysis, trends, and reporting skills. Ability to read and interpret documents. Ability to write clearly and informatively technical documentation, routine reports, correspondence, procedures, and workflows. Presents numerical data effectively. Attention to detail without losing site of the big picture.
• Identifies and resolves problems in a timely manner; develops alternative solutions; works well in a group problem-solving situation; presents ideas and information in a manner that gets others' attention; displays willingness to make decisions; exhibits sound and accurate judgment; supports and explains the reasoning for decisions includes appropriate people in decision-making process.
• Strong project management skills, including the ability to prioritize, balance, and manage multiple efforts with strong results/goal orientation.

COMMENTS
Infectious Control Risk Category II:
The risk category explains whether or not employees are likely to come into contact with blood or body fluids while performing their jobs. Risk category II states employment and procedures that may require exposure.