Staff Quality Engineer, Supply Chain Quality (SCQ)

Company: Ortho-Clinical Diagnostics
Location: Rochester
Posted on: June 10, 2021

Job Description:

The Career Potential

Ortho Clinical Diagnostics is committed to improving and saving lives with diagnostics. To do this we hire people who share this dream and are ready for new adventures. As a valued team member, you will carve your own career path and be part of building this company stronger and better than ever before. There is no limit to the experiences, opportunities and new directions you will have access to here at Ortho Clinical Diagnostics. More importantly, you will be driving the surge of a whole new direction in important medicine. That's something we can all take pride in as we take this journey together.

Ortho is known in the industry as a leader in customer service and support. Deeply understanding and exceeding the needs of our clinical lab, hospital and blood bank customers is what we do. It's who we are. If you join Ortho, no matter what your role, you will be expected to keep that Customer Excellence focus in your work.

The Opportunity

This position is focused on quality oversight of Ortho's Supply Chain functions including oversight to primary distribution hub warehouses and transportation providers. The responsibilities span all quality elements associated with the supplier management process. Ensures the management of non-conformance, complaint investigations, CAPA, change control and quality metrics. Identify and drive implementation of improvement opportunities. Lead and support Supply Chain Quality Projects. Develop and maintain effective working relationships with Ortho business partners and critical suppliers in order to drive an effective supplier management process consistent with a quality oversight model.

The work shall be performed to ensure compliance with applicable Regulatory requirements (cGMP, cGDP, ISO9001, ISO13485, 21 CFR 820, Directive 98/79/EC, upcoming 2017/745 regulations).

The Responsibilities

• Perform supplier quality oversight via active review and management of non-conformances, creation and review of quality metrics as part of the Supplier Performance Scorecard process. Works independently to issue and investigate supplier delivery, quality, and compliance nonconformances using a systematic approach to problem solving, conducting risk analyses and ensures appropriate corrective and preventative actions. Support activities required for approval and continuous monitoring of suppliers.
• Lead or participate in teams to investigate product quality issues (Failure Investigations) to resolve complaints, non-conforming products and CAPA. Drive strategic direction of supplier quality elements in distribution investigations.
• Serve as quality oversight for validation of changes to shipping lanes and distribution packaging configurations. Also support change control processes for Supply Chain projects.
• Lead and execute on-site supplier audits.
• This position may require up to approximately 30% domestic and international travel.

The Individual

• A minimum of a bachelor's degree or equivalent is required. A related science or engineering field of study is preferred.
• A minimum of 5 years of experience in a quality-related field is required, preferably within a medical device environment.
• 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 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.

Desirable

• 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.

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Keywords: Ortho-Clinical Diagnostics, Rochester , Staff Quality Engineer, Supply Chain Quality (SCQ), Other , Rochester, New York