compensation: Negotiable - email for more details. employment type: full-time
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CORE JOB RESPONSIBILITIES:
• Own the nonconformance (NCR) process and appropriate documentation.
• Prepare metrics for NCRs, CAPA, suppliers’ performance and analyze process data and trends and drives
optimization and improvement.
• Interface with suppliers to ensure product meets specifications.
• Maintain supplier records including supplier evaluations.
• Maintain/publish the approved supplier list.
• Support the equipment or tool calibration program.
• Participate in external audits and in the execution of the internal audit plan.
• Make recommendations for corrections and corrective actions.
• Audit the work of others through review of labeling, documentation (MPI’s, LHR’s, etc.) and lot history
records and provide final quality approval.
• Support sterilization activities and documentation (submission forms, LAL, Bioburden, etc.)
• Work within a GMP environment and document results per GDP standards. Holds R&D, and operations
accountable to GMP and GDP requirements.
• Ensure training requirements for internal and external staff are established and maintained in a training
• Conduct and assign training initially for new staff and follow up on training due to changes or re-review.
• Leads cross-functional teams to achieve consensus for deliverables associated with quality issues.
• Bachelor’s degree in Engineering or equivalent or a related field.
• Experience in relevant medical device regulatory requirements and standards (e.g. ISO, IEC, MDD, QSR,
• Proven experience in relevant areas of Quality, Regulatory or Engineering, preferably within a medical
• Strong written and verbal communication skills and ability to collaborate effectively.
• Capable of producing results working unsupervised under own initiative.
• Must be an effective team player with the ability to mentor, lead and problem solve to provide solutions to the
• Confident and open personality who is able to communicate effectively, both written and orally with people at
• Experience with external/internal audits and EtO Sterilization a plus.
• Ability to work efficiently under tight timelines.
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