QA Analyst ensuring product quality and customer satisfaction at Cytiva. Collaborating on quality records and leading continuous improvements in manufacturing and operational activities.
Responsibilities
Drive Product Quality and Customer Satisfaction by reviewing and approving quality records, both internal (e.g. NCR, Change Control, risk assessments etc.) and customer facing.
Collaborate with colleagues to analyze, develop and improve upon quality KPIs to drive Customer Satisfaction.
Lead continuous improvement initiatives for manufacturing production and QMS processes in collaboration with cross functional teams using process mapping, fishbone diagram, 5S, and other continuous improvement tools.
Conduct and improve QA Operational activities, such as routine in-coming, in-process and final inspections.
Develop and deliver training materials to colleagues on procedures, technical writing, and compliance requirements, etc.
Requirements
A post-secondary degree in Science or Engineering discipline
3+ years of quality assurance experience in a biotech industry, medical device, or other relevant experience
Exceptional analytical, problem solving & root-cause analysis skills for moderate to highly complex issues
Experience with leading short and long term projects related to process improvements for QMS and QA Operations within ISO 9001 or ISO 13485
Excellent technical writing, verbal and written communication skills
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