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Senior Quality Engineer Validation and Risk
Senior Quality Engineer Validation and RiskSHL Medical • North Charleston, SC, US
Senior Quality Engineer Validation and Risk

Senior Quality Engineer Validation and Risk

SHL Medical • North Charleston, SC, US
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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

  • Validation experience in medical device, pharmaceutical or biotechnology industry.
  • End to End validation mindset and skills.
  • Extensive tech transfer process validation is required.
  • Demonstrate use of Risk-based approach. Good knowledge of FDA, GxP, ISO 13485, and ISO 14971.
  • Good communication and interpersonal skills and demonstrate ability to participate in inter-departmental discussion and resolve challenges a timely manner.

    • We Offer

  • Competitive compensation package.
  • Modern working environment with state-of-the-art facilities and technologies.
  • Challenging assignments in a fast growing and innovative industry.
  • Position in a dynamic, international team of highly skilled professionals.
  • Various opportunities for personal and professional development within a global organization.

    • 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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    Validation Engineer • North Charleston, SC, US