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.
As a proud part of the Alcon group, Cylite’s 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, we’re looking to rapidly scale our product offering and production capabilities.
Job Description
The main purpose of this job is to 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 Cylite’s 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 in continuous improvement initiatives within the manufacturing environment, with a particular regard to product and process quality.
- Target 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.
- Other duties as required by Quality Control Manager.
Attributes
Is self-driven, reliable, and responsible; is willing to take ownership.
Can plan and prioritise effectively to meet project milestones and deadlines.
Has valuable 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:
- Bachelor’s Degree in Engineering or the Physical Sciences.
- Minimum 3 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.
- 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).
Alcon is an equal opportunity employer and participates in E-verify. We take 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.
#J-18808-Ljbffr
📌 Quality Engineer
🏢 Alcon
📍 Melbourne