Senior Quality Engineer Validation and Risk

Senior Quality Engineer Validation and Risk

Location : Charleston, South Carolina, US

Senior level Validation personnel who applies regulatory, compliance and engineering knowledge to set requirements related to end to end process validation. Candidate ensures risk-based validation approach is implemented while maintaining compliance to external regulations including FDA Quality System Regulation (21 CFR Part 820), ISO 13485, ISO 11608 & ISO 14971.

Main Responsibilities

• Lead risk evaluation of existing validation strategies against mass production NCMRs, CAPAs, and Change Controls.
• Establish new validation strategies based on above risk evaluation to ensure validated process deliver products that meet customer requirements consistently.
• Derive implementation strategies of above mentioned changes on validation strategies.
• Work with QE program managers and cross functional team include but not limited to Tech Transfer team, manufacturing engineering team on prioritizing the implementation strategies to ensure timely, risk-based, and effective implementation.
• Participate in tech transfer projects to ensure accurate risk identification and mitigations are in place of each tech transfer.
• Review and approve the Master Validation Plan and Validation Plans of respective projects, ensuring the criteria are aligned to NCHS site, customer, regulatory, quality and risk requirements.
• Manage a team of risk and validation engineers.
• Hiring, develop and retain risk and validation engineers.
• Collaborate with Risk Management and Quality personnel to ensure all critical to quality attributes are validated to the right level and sustenance plans are set in place for mass manufacturing.
• Drive CAPA related to general SHL validation process and participate in product related CAPA when necessary.
• Ensure all validation records are maintained and periodic verification executed by process owners according to compliance requirements.
• Conduct internal audits.
• Support test development activities.
• Perform other related duties as assigned.

Skills and Qualification

We Offer

Please note that SHL is a drug-free employer. This offer of employment is contingent upon your successful completion of various pre-employment screenings, including, but not limited to, a drug test, employment verification, reference checks, and a criminal background check.

For more information on SHL Medical, please visit : shl-medical.com

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