Career Opportunities

Senior Quality Engineer

Posted on: Tuesday, September 7, 2021
Organization: Ortho Clinical Diagnostics
Location: Memphis, TN
Description:

As Ortho continues to grow, we are seeking a Senior Quality Engineer to work in our Memphis warehouse. This Senior Quality Engineer is focused on quality oversight of Ortho’s primary distribution hub warehouse. The responsibilities span all elements associated with the execution of quality management system activities to ensure product integrity via adequate material and process controls. Utilize key Quality Engineering (QE) principles, tools, and practices to develop and optimize process controls and quality system processes that are aligned with the overall business goals and Ortho’s Quality Policy. Ensures the management of non-conformance, complaint investigations, CAPA, and quality metrics. Identify and drives continuous improvement to enhance quality, compliance, and overall customer service. Lead and support Supply Chain Quality Projects. Develop and maintain effective working relationships with Ortho business partners and critical suppliers to to ensure compliance with quality, regulatory and business needs.

The work shall be performed to ensure compliance at distribution hub to the necessary medical device regulations given the scope of operation (i.e., cGMP, cGDP, ISO 9001, ISO 13485, FDA 21 CFR 820, EU Directive 98/79/EC, upcoming 2017/745 regulations) and in alignment with Company requirements.

This position is located in Memphis, Tennessee.

Responsibilities:

  • Issue and investigate delivery, quality, and compliance nonconformances that occur at the distribution hub using a systematic approach to problem solving, conducting risk analyses and ensures appropriate corrective and preventative actions and CAPA effectivity. Utilize process excellence tools as appropriate. Partner with operations or other stakeholders to implement process improvements and address quality events including non-conformances, root cause investigation, product disposition.

  • Investigate and resolve quality elements for distribution related investigations that are reported by customers or other distributors. Lead or participate in teams to investigate product and non-product quality issues (Failure Investigations) to resolve complaints, nonconformances and CAPA.

  • Support execution of quality management system activities to ensure to ensure compliance at distribution hub including (but not limited to): change control, document control, training processes, support for internal and external audits. Track and trend quality data such as non-conformances, RCI, CAPA and Change Control.

  • Execute non-Conformance and Product Disposition associated with distribution issues and temperature excursion assessments in accordance with the company/department procedures and compliance with Quality System regulations..

  • Serve as quality oversight for validation of changes to shipping lanes and distribution packaging configurations.

  • Support change control processes for Supply Chain projects.

Requirements:

Qualifications:

  • Minimum of a bachelor’s degree or equivalent is required. A related science, engineering or supply chain field of study is preferred.

  • Minimum of 5 years of of related work experience in Quality is required.

  • Experience in a highly regulated manufacturing environment (Diagnostics, Medical Device, Pharmaceutical or Consumer) is preferred, but not required.

  • Knowledge and skills in quality-related methods and techniques including auditing principles and techniques, quality terminology, quality management principles and their applications and quality management tools and their applications is required.

  • Ability to work in a fast-paced environment with multiple, concurrent priorities with many needing immediate resolution and adopting a sense of urgency accordingly, while maintaining a focus on customer satisfaction.

  • Demonstrated experience developing a wide range of solutions for supply chain, manufacturing and/or supplier problems, and the ability to understand business as related to projects and opportunities is required.

  • Ability to build partnerships both internally and externally at all levels of the organization is required. Must have the ability to influence while not having direct authority.

  • Good written and oral communication skills are required.

  • Ability to use PC's and associated Microsoft software required.

  • Strong working knowledge of applicable regulations (FDA CFR Part 820, Part 11 regulations, and ISO 13485 standards) is highly preferred.

  • Validation experience is highly preferred.

  • Proven ability to conduct and manage audits is preferred.

  • Ability to solve complex problems, make risk-based decisions and navigate through ambiguity is preferred.

  • Ability to lead a team through a root cause analysis problem is preferred.

  • Process Excellence Certification (e.g. Black Belt/Green Belt), Six Sigma, Lean, ISO Lead Auditor, or ASQ CQA/CQE certification and training are preferred.

  • The position may require up to 10% travel (Domestic and International).

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