Sr. Associate, Quality Assurance

Alcon; City of Monash; On-site; AUD 90,000 - 130,000; Full time

Job summary

Alcon is seeking a Quality professional to support manufacturing quality across product designs and processes. You will work with Quality, NPI, Production and Engineering to ensure compliance with QMS, regulatory standards and customer requirements.

You will lead QC inspections, investigate non-conformances and drive CAPA and continuous improvement initiatives. The role requires a Bachelor’s degree in a relevant field, 4+ years in a quality role, and experience with ISO 9001/13485 and medical

Qualifications

• Requires Bachelor's in Engineering or Physical Sciences.
• Minimum 4 years in a quality role in manufacturing.
• Experience with ISO 9001 / ISO 13485 / FDA QSR 21 CFR 820.
• Proficient in Microsoft Office and ERP systems.
• Excellent written and verbal communication; detail-oriented.

Responsibilities

• Develop deep product and process quality expertise.
• Assist Quality Manager to develop QC plans and processes.
• Collaborate with Quality, NPI, Production and Engineering to define quality benchmarks and acceptance criteria.
• Perform in-process QC inspections and tests.
• Investigate non-conformances and drive corrective actions.
• Lead or participate in continuous improvement initiatives (Kaizen, Lean, Six Sigma, 5S).
• Assist with audits and quality data analysis.
• Implement process monitoring tools (SPC) and CAPA processes.
• Maintain collaboration with regulatory bodies and ensure compliance.

Skills

Quality management

Problem solving

Communication

Attention to detail

Project planning

Cross-functional collaboration

Process improvement

Education

Bachelor’s degree in Engineering or Physical Sciences

Tools

Microsoft Office

ERP systems

Atlassian Confluence

Jira

Job description

At Alcon, we're passionate about enhancing sight and helping people see brilliantly. With more than 25,000 associates, we innovate fearlessly, champion progress, and act swiftly to impact global eye health. We foster an inclusive culture, recognizing your contributions and offering opportunities to grow your career like never before. Together, we make a difference in the lives of our patients and customers. Are you ready to join us?

Main Duties

• Develop a high-quality level of personal expertise on Cylite’s product designs, construction of assemblies, and all corresponding documented processes.
• Assist Quality Manager to develop Quality Control plans and processes.
• Collaborate with Quality, 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 as required against plans and acceptance criteria.
• Collaborate with Quality, 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 Quality 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 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.
• Process NCR resolution (control of non-conforming product
• Work with stakeholders to improve process using CAPA process (corrective and preventive action)
• Other duties as required by Quality Manager.

Attribute-based:

• 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:

• Bachelor’s Degree in Engineering or the Physical Sciences.
• Minimum 4 years of experience in a quality role.
• Prior experience in a manufacturing environment, preferably in either a medical device, pharma, optics, electronics or mechanical/automotive 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 working with Optics or mechanical background
• 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).

Join a global leader with a rich history of innovation and excellence in eye care.

Be part of a collaborative and supportive team culture that values diversity and inclusion.

Enjoy a competitive compensation package and opportunities for career advancement.

Make a meaningful difference in the lives of patients worldwide by contributing to cutting‑edge advancements in eye health.

All applicants need to have full Australia work rights.