Manufacturing/Medical Device Quality Engineer (Onsite)

• Experience in a manufacturing and operations environment is a must.
• Handling customer complaints, conducting investigations, and quality improvement.
• Bachelor's or Master's Degree in biology, chemistry, biotechnology, engineering, or a related field, or equivalent experience.
• Post-graduate, Quality Assurance Certifications, such as Six Sigma, CQE, CQA, etc., is preferred.
• 4+ years of experience in a similar position within the Life science industry.
• Experience with medical device regulations, such as ISO 13485, FDA 21 CFR part 820, and preferred IVDR 2017/746.
• Strong organizational and analytical skills with a focus on finding effective and efficient solutions in compliance with the regulations.
• An effective communicator at all levels, both internally and externally.
• Team player with the ability to make independent decisions within the framework and guidelines of the organization.

• Drives quality assurance activities related to batch review, change control, NCRs, Deviations, CAPAs, Audits, and supports Product Complaints technical investigations for the relevant product platforms.
• Support 3rd party audit of site through audit prep and participating in the front/back room.
• Apply advanced Quality Assurance and Scientific Method techniques and principles to daily tasks and activities.
• Apply relevant regulations, standards, GxP requirements, and industry best practices to assignments.
• Plan and conduct projects and activities with moderate to high technical responsibility, complexity, and strategic feedback.
• Act as an SME in quality assurance and scientific matters as applicable.
• Develop and drive key strategic quality assurance initiatives throughout the organization.
• Contributes to the development of new projects/programs/processes.
• Lead/drive root cause investigations for multiple issues, including complaints, NCRs, Deviations, OOS, etc.
• Leads projects requiring representation of the organization to internal and/or external customers or others, providing expertise and promoting solutions.

Candidates must provide their phone number. Job reference number is A5189.