Job Title: Quality Assurance Specialist
Job Purpose:
To provide expert QA support to Operations, in ensuring operational goals and objectives are achieved for the plant.
Key Responsibilities:
* Drive and implement process improvements to ensure predictable processes across shipping and boxpack processes (e.g. Risk Reduction, Yield improvements, Customer complaint reduction, Error proofing, Cost Reduction initiatives, Process Automation activities).
* Provide effective and responsive QA support to Operations to meet their area's objectives of quality, cost and output.
* Ensure all process variables and their interactions are adequately defined.
* Ensure all failure modes in process have been identified and addressed.
* Drive and implement plant wide quality system improvements.
* Ensure Regulatory compliance in area of responsibility to cGMP's of all medical device regulatory agencies.
* Provide functional expertise to other support functions on quality related issues.
* Identification and implementation of appropriate statistical techniques to monitor process performance.
* Approval of change requests for product, process and quality system changes.
* Customer complaints: Analysis of returns, approval of analysis reports and analysis of complaint trends.
* Validation: Define process, product and test method validation requirements, preparation and approval of Master Validation Plans, protocols and reports approval.
* Compilation of required Regulatory documentation.
* MRB: Review of MRB trends and identification of appropriate corrective actions when required.
* Support the implementation of Lean Manufacturing across the site.
* Transfer and implement product and processes from development or from another manufacturing facility.
Requirements:
Minimum of Bachelor of Science Degree in Engineering/Technology.
3-4 years' experience in a manufacturing environment or equivalent with direct experience in a QA environment (preferably GMP regulated).
Experience in the medical device industry is an advantage.
Benefits:
As a leader in medical science for more than 40 years, we are committed to solving the challenges that matter most – united by a deep caring for human life.
Our mission to advance science for life is about transforming lives through innovative medical solutions that improve patient lives, create value for our customers, and support our employees and the communities in which we operate.
Now more than ever, we have a responsibility to apply those values to everything we do – as a global business and as a global corporate citizen.
So, choosing a career with us isn't just business, it's personal.
And if you're a natural problem-solver with the imagination, determination, and spirit to make a meaningful difference to people worldwide, we encourage you to apply and look forward to connecting with you.
Company Culture:
We recognise that nurturing a diverse and inclusive workplace helps us be more innovative.
It is essential in advancing science for life and improving patient health.
We stand for inclusion, equality, and opportunity for all.
By embracing the richness of our unique backgrounds and perspectives, we create a better, more rewarding place for our employees to work and reflect the patients, customers, and communities we serve.