Job Description:
As a Quality Engineer, you will play a crucial role in ensuring operational goals and objectives are achieved for the plant.
You will drive and implement process improvements to ensure predictable processes across shipping and boxpack processes. This includes risk reduction, yield improvements, customer complaint reduction, error proofing, cost reduction initiatives, and process automation activities.
Providing effective and responsive QA support to Operations is also a key responsibility, meeting their area's objectives of quality, cost, and output.
Ensuring all process variables and their interactions are adequately defined is essential. You will also identify and address all failure modes in process, using techniques such as DOE studies and FMEA's.
Additionally, you will drive and implement plant-wide quality system improvements, ensuring regulatory compliance in your area of responsibility to cGMP's of all medical device regulatory agencies.
Functional expertise will be provided to other support functions on quality-related issues, including regulatory requirements, statistical techniques, sampling principles.
Monitoring process performance through the use of statistical techniques such as SPC and CpK analysis is also critical.
Approval of change requests for product, process, and quality system changes, as well as customer complaints analysis, return approval, and complaint trend analysis, will be required.
Validation of processes, products, and test methods will also be necessary, including the preparation and approval of Master Validation Plans, protocols, and reports.
Compilation of required regulatory documentation, such as technical files, design dossiers, and product transfer files, will be essential.
MRB trends review and identification of corrective actions when required will also be part of your responsibilities.
Finally, supporting the implementation of Lean Manufacturing across the site and transferring and implementing product and processes from development or another manufacturing facility will be required.
Required Skills and Qualifications:
* 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:
We offer a diverse and inclusive workplace where you can grow and develop your skills and career.
With access to the latest tools, information, and training, you will have the opportunity to advance your knowledge and make a meaningful difference in patient lives.
Our mission to advance science for life is about transforming lives through innovative medical solutions that improve patient health, create value for our customers, and support our employees and communities.
We recognize that nurturing a diverse and inclusive workplace helps us be more innovative and better serve our patients, customers, and communities.
Equal opportunities and affirmative action employer, committed to providing reasonable accommodations for applicants and employees with a disability.
Key Responsibilities:
* Drive and implement process improvements to ensure predictable processes across shipping and boxpack processes
* Provide effective and responsive QA support to Operations
* Ensure all process variables and their interactions are adequately defined
* Identify and address all failure modes in process
* Drive and implement plant-wide quality system improvements
* Ensure regulatory compliance in your area of responsibility
* Provide functional expertise to other support functions
* Monitor process performance using statistical techniques
* Approve change requests for product, process, and quality system changes
* Analyze customer complaints
* Validate processes, products, and test methods
* Compile required regulatory documentation
* Review MRB trends and identify corrective actions
* Support Lean Manufacturing implementation
* Transfer and implement product and processes from development or another manufacturing facility