Quality Engineer

vor 2 Wochen


City of Melbourne, Österreich Alcon Research Vollzeit

At Alcon we are driven by the meaningful work we do to help people see brilliantly. We innovate boldly champion progress and act with speed as the global leader in eye care. Here youll be recognised for your commitment and contributions and see your career like never before. Together we go above and beyond to make an impact in the lives of our patients and customers. We foster an inclusive culture and are looking for diverse talented people to join Alcon. As a proud part of the Alcon group Cylites innovative product range is redefining how optometrists ophthalmologists and researchers detect and treat eye disease with its patented technology. With customers across USA Europe and Australia were looking to rapidly scale our product offering and production capabilities. MAIN PURPOSE OF JOB Work with the QC Manager to develop and implement QC inspections tests acceptance criteria for our products and sub-assemblies and investigate and help remedy quality issues. MAIN DUTIES Develop a high-quality level of personal expertise on Cylites product designs construction of assemblies and all corresponding documented processes. Assist QC Manager to develop Quality Control plans and processes. Collaborate with QA NPI Production and Engineering teams to define product quality benchmarks and acceptance criteria to meet QMS Regulatory and Safety Standards and Customer requirements. Perform in-process QC inspections and tests against plans and acceptance criteria. Perform final product inspection and release in accordance with product release checklists. Collaborate with QA NPI Production and Engineering teams to investigate and report on root causes of non-conforming products and raise / drive corrective actions when needed. Collaborate with QA team to review quality issues to prevent non-conformance and defects and recommend / implement preventive actions. Investigate the underlying causes of non-conformances to ensure that supplied components meet our quality standards. Lead or participate continuous improvement initiatives within the manufacturing environment with a particular regard to product and process the reduction or elimination of process variations. Raise quality issues to prevent any process which is not conforming to standard or deemed to be defective; implement corrective actions. Assist with any preparation required for internal and external audits. Assist with creating and analysing reports from quality data. Implement tools for monitoring process capabilities (SPC) analyse the data generated and report. Process NCR resolution (control of non-conforming product Work with stakeholders to improve process using CAPA process (corrective and preventive action) Communicate issues with supplier monitor performance and resolve component / product issues using SCAR process (Supplier Corrective action report) Other duties as required by Quality Control Manager. Attribute-based Pays good attention to detail. Is self-driven reliable and responsible; is willing to take ownership. Can plan and prioritise effectively to meet project milestones and deadlines. Has good oral and written communication skills; can collaborate effectively with cross-functional team members. Has good knowledge and experience with quality management systems. Has good problem-solving skills. EXPERIENCE / QUALIFICATIONS Required Bachelors Degree in Engineering or the Physical Sciences. Minimum 4 years of experience in a production quality role. Prior experience in a high-technology manufacturing environment preferably in either a medical device or optics-related industry. Knowledge and experience with quality management systems (ISO 9001 / ISO 13485 / FDA QSR 21CFR820). Proficient computer skills in Microsoft Office and ERP Systems. Excellent communication skills (written and verbal) and attention to detail. Demonstrated problem solving ability. A passion for precision and quality. Effective communication skills can collaborate effectively with team members and train production technicians. Desirable Experience working with Atlassian Confluence and Jira. Experience in continuous improvement methods such as Kaizen Lean Six Sigma and 5S. Knowledge and experience with medical device regulations (TGA / FDA / EU MDR). Experience in collaborating with notified bodies and regulatory authorities. Experience with validation (process / equipment / QMS software). Internal auditor / lead auditor certification (ISO 9001 / ISO 13485 / MDSAP). Why Join Alcon Full-Time Role : Standard day shift with stable hours. Cutting-Edge Technology : Work with innovative medical imaging products that make a real impact. Exciting Work Environment : Be part of a fast-growing award-winning company. Supportive Culture : Join a team built on integrity collaboration and continuous improvement. Applicants must have the right to live and work in Australia. Alcon Careers See your impact at IS AN EQUAL OPPORTUNITY EMPLOYER AND PARTICIPATES IN E-VERIFY Alcon takes pride in maintaining a diverse environment and our policies are not to discriminate in recruitment hiring training promotion or other employment practices for reasons of race color religion gender national origin age sexual orientation gender identity marital or veteran status disability or any other legally protected status. Alcon is also committed to working with and providing reasonable accommodation to individuals with disabilities. If because of a medical condition or disability you need a reasonable accommodation for any part of the application process or in order to perform the essential functions of a position please send an email to and let us know the nature of your request and your contact information. EQUAL EMPLOYMENT OPPORTUNITY POSTERS If youd like to view a copy of the Alcons affirmative action plan or policy statement please email . ATTENTION : Current Alcon Employee / Contingent Worker If you are currently an active employee / contingent worker at Alcon please click the appropriate link below to apply on the Internal Career site. Find Jobs for Employees Find Jobs for Contingent Worker Key Skills APQP,Quality Assurance,Six Sigma,ISO 9001,PPAP,Minitab,Root cause Analysis,ISO 13485,Quality Systems,Quality Management,As9100,Manufacturing Employment Type : Full-Time Experience : years Vacancy : 1 #J-18808-Ljbffr


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