Be among the first 25 applicants
Overview
Enhance customer experience and boost productivity by improving Quality Management System processes. You will provide Quality Assurance support to medical device manufacturing and testing facilities at the MBD Thebarton site to strengthen our quality system and drive continuous improvement.
Key Responsibilities
Investigate and report on internal batch failures and customer complaints.
Coordinate and support Production and Quality Control to investigate problems, analyse trends, identify root causes, and implement corrective actions for processes and products.
Promote quality-focused decisions using sound problem-solving methods to identify, prioritise, and resolve quality issues, reducing technical risk and improving efficiency.
Report results and investigation findings in an accurate, clear, and concise manner.
Maintain and manage the Incident & CAPA systems to drive completion within metrics targets.
Provide QA support and approvals to Operations for validation protocols, validation reports, change control, SOPs, and in-process controls.
Complete process/product validation testing and prepare reports as needed.
Mentor and assist production team to maintain ISO13485/Quality system compliance including developing SOPs and standard work instructions for consistent process control.
Facilitate risk management activities across all quality system processes in line with medical device standard requirements.
Perform QA review and approval of external calibration and maintenance reports in addition to assisting site maintenance team to maintain compliance with ISO13485.
Author and deliver QMS and process training when required.
Engage in completing the site Internal audit program and assisting with third party/customer audits
Frequent Contacts
Internal: Site Quality Manager & QA/QC Team, Production Engineer, Operations Leaders, Production Operators, Maintenance staff.
Division: MBD Senior Validation Manager (UK).
External: Suppliers and customers as required.
Qualifications & Experience
Tertiary qualification required in an Engineering or Science-related field.
Minimum of 3-5 years of quality assurance/quality systems experience.
Proficiency in Excel and Word.
Lean Six Sigma Green Belt or similar process improvement qualification.
Experience in a medical device or pharmaceutical manufacturing environment desirable.
Internal auditing experience favourable.
Skills & Abilities
Able to use own initiative, prioritise multiple tasks, and achieve goals within agreed timeframes.
Team-focused with proven ability to coordinate activities and influence outcomes across teams and functions where no formal authority exists.
Effective written and oral communication skills.
Strong problem analysis and decision-making skills.
Expertise in quality-related tools like structured problem solving, FMEA, SPC, DOE, and Lean-Six Sigma/PPI.
Understanding of Medical device, GMP, or ISO 13485 principles.
Other Job Requirements
Projects or other work as determined by the Quality Manager or site leadership team.
Support and actively participate in the company PPI (Continuous improvement) program.
Additional work outside regular hours may occasionally be necessary.
Benefits
Health & Wellbeing: Comprehensive benefits, wellness programs, and an Employee Assistance Program providing confidential support for personal and work-related issues.
Flexibility: Flexible work arrangements to balance work and personal life.
Extra Leave: Generous leave policies, including the option to purchase additional leave, paid birthday leave, and company paid parental leave.
Charitable Giving & Volunteering: Paid volunteer time to support non-profit organizations.
Learning & Development: Access to Thermo Fisher Scientific University Plus and LinkedIn learning, workshops, and mentorship programs.
Thermo Fisher Scientific Australia is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.
#J-18808-Ljbffr