Total 218 Manager level Quality Assurance / Control job vacancies in North Sydney, New South Wales

Quality Manager - Leading Civil Engineering Contractor - Snowdonia

A Leading Civil Engineering Contractor, are currently looking to appoint an experienced Quality Manager to be based permanently on site on one of their biggest schemes valuing at £300M.

Main Responsibilities:

The Quality Manager will work closely with the project managers across the project providing fundamental support to their project and team. Overseeing the management and quality reporting process and systems, ensure compliance across relevant documents, assist with planning and document control ensuring the projects are completed to best standard following best practice.

Your responsibilities will include (not exhaustive):

• Implement both company and client Quality Management Systems.
• Be the primary point of contact for the client regarding any Quality issues.
• Establish and enforce quality standards and measurement systems.
• Conduct quality audits on sites, suppliers & consultants.
• Establish & build quality control systems and implement across site.
• Build training programmes and ensure training is conducted to the correct individuals.

The Ideal Candidate:

• You will be required to provide flexibility in this role a car / allowance is provided with this role so you must have a FULL UK manual car driving license.
• You will have experience within a similar role with a large civil engineering/ infrastructure project.
• Strong knowledge and experience of BIM legislation and regulations, as well as industry best practice.

• Membership of the Chartered Quality Institute or institution of Civil Engineers.
• Experience and understanding of ISO 19650 and 4Projectts, A-Site and Projectwise.

Benefits:

The successful applicant in the role of the Quality Manager will be instrumental in the future development of the company's culture to achieve the benefits available through their continuous improvement strategies. My client is prepared to offer a highly comprehensive package + benefits package, including a relocation allowance. For further information, please apply today with an up-to-date copy of your CV or contact Claire Spiers in our Southampton Office on 07749578588 or email cspiers@fr-group.co.uk.

Job Duties:

• Manage the process for QMS audits, to ensure compliance of the organization’s Integrated Management Systems wrt ISO9001/TS16949/ VDA 6.3, Customer specific requirements.
• Identify areas/ system gaps for improvement and implementation. Establish and drive QMS enhancement and integration roadmap/milestones.
• Work closely with Operations and key stakeholders to maintain consistent manufacturing, quality policies and compliance
• Responsible for maintaining/improving fab performance though SPC program.
• Investigate root causes and resolve key fab-related quality issues and effectiveness of corrective and preventive actions. Manage Non-Conformance cases with respect to on-time closure with the relevant customers/Business Lines.
• Responsible for Outgoing and Periodic review OQA performance to drive defect reductions
• Responsible for Document Centre Management & Library Services
• Management of change among diverse cultures in a fast paced environment
• Co-work with related functions to support the wafer fabrication process to drive process/system optimization and effectiveness

Job Qualifications:

• Degree in Chemical / Electrical Engineering / Physics / Chemistry or equivalent
• 8+ years in semiconductor industry preferred
• Knowledge of wafer fabrication process essential
• Strong in project management skills, facilitation, analytical skills and system thinking

Job Description & Responsibilities:

• Maintenance of Quality Management System ensuring compliance to internal, and international standards and regulatory requirements for medical devices.
• Develop QMS documents in line with business activity of DxD Hub.
• Work with technical team to create quality document related to product design, development and manufacturing, including product test/validation protocols, change management in compliance to applicable regulatory requirements.
• Develop and evaluate medical device regulatory intelligence and maximize opportunities to expedite the registration process within S.E.A region, China and USA. Activities include obtaining and maintaining domestic and regional market access for our innovative products.
• Provide appropriate inputs to assist in defining regulatory strategies and timelines for regulatory submissions for the total product lifecycle for medical devices.
• Compile technical, clinical and production protocols and documentations necessary for new products dossier submission to S.E.A. region, China and USA. regulatory submissions. Liaise with technical team (locally and internationally) on technical information required to prepare submission dossiers. Manage preparation (developing submission content, management of document legalization, and creation of any other documents required for submissions) and maintenance of regulatory submissions and other premarket registrations to acquire appropriate commercial distribution clearances in accordance with regulatory strategic plan.
• Overall responsible for ensuring that medical device files are set up in compliance to regulatory requirement.
• Monitor and communicate new and changing medical device law, guidance regulations in a timely manner. Reviews process change recommendation and assists in implementing new procedures and documentation.
• Ensure that regulatory records are controlled and maintained.
• Train internal and external stakeholders on regulatory data management processes and platforms, regulatory matters and product registration.

Job Requirements:

• Master or Bachelor of Science/Engineering with strong background in biomedical, computer or engineering sciences.
• Possess 3 years or more of working experience in quality assurance and regulatory affairs in medical devices; thorough working knowledge of ISO 13485:2016.
• Good working knowledge in managing QMS in a medical device environment in compliance to ISO 13485:2016.
• Competent in quality assurance methodologies.
• Working knowledge in QA processes for design, development and manufacturing of IVD, SaMD and Integrated Medical Technologies.
• Demonstrated skills in risk management (ISO 14971).
• Knowledge of Health Sciences Authority requirement for IVD product submission.
• Knowledge in regulatory requirements for medical devices in ASEAN, USA and EU.
• Experience with product registration submission and evaluation.
• Experience with maintaining internal regulatory database.
• Experience with Dossier Creation.
• Ability to develop and implement plans for regulatory submission.
• Awareness of applicable workplace environment, health and safety regulations.
• Ability to network and build strategic partnership with good problem solving skills and communication skills.
• Possess leadership and agile mindset.

The above eligibility criteria are not exhaustive. A*STAR may include additional selection criteria based on its prevailing recruitment policies. These policies may be amended from time to time without notice. We regret that only shortlisted candidates will be notified.