Senior QA Engineer-Audits
TalentSource is an Executive Search company providing value-added talent solution to MNC and local clients. We build meaningful and rewarding relationships between top-tier executives and our valued clients, while actively catering to both parties� need for confidentiality, dignity, integrity and professionalism.
Responsibilities
To coordinate the planning, conduct, reporting and resolution of issues associated with the quality and environmental audit programs, fostering a Quality and Environmental culture and ensuring ongoing audit readiness across the business.
Prepare and implement internal and supplier audit programs that meet the requirements of the business and applicable external regulatory bodies.
Provide reports to management on the status of the audit program and provide an assessment of the possible resulting business impact.
Project manage the activities resulting from observations and non-conformances raised during internal audits, liaise with stakeholders and drive these findings to effective and timely closure.
Review and interpret audit observation activities and evidence for completeness prior to closure.
Support and represent company in external audit situations through audit preparation, facilitation and acting as a direct auditee when required, including preparation of formal responses to external audits ready for management review prior to submission.
Recommend opportunities for the continual improvement of the audit system in accordance with best practice and individual analysis of specific company needs and lead implementation.
Work with corresponding QA teams in other country to ensure that the audit systems are aligned and suitable for global deployment where appropriate.
Support the maintenance of QA supplier management and ongoing supplier monitoring activities to facilitate effective supply chain management to ensure external regulatory compliance requirements are met.
Undertake other QA project activities as required.
Requirements
Bachelor Degree in Engineering/Science with at least 5 - 8 years applied professional quality assurance experience from Medical device, Pharmaceutical, Electronic, Engineering, Science Automotive, Aviation or Biotechnology industry.
Formal training in Quality Systems audits and significant audit experiences, prefer to have good knowledge of ISO9001 and ISO13485.
Acted as lead auditor for internal and supplier audits.
Experience in covering a range of relevant processes and supplier types also support of relevant certification and regulatory audits, e.g. FDA or TGA.
Excellent verbal and written communication skills.
Strong systems thinking/engineering approach.
Strong business acumen and general business experience.
Sound analytical problem solving, ownership of challenges and timely decision making abilities.
Ability to work collaboratively with stakeholders from across the business and geographies to build a quality culture aligned with business goals
Address audit issues and raise the profile and reinforce the value of the audit program through effective collaboration with business stakeholders.
