Staff Quality Engineer, Supply Chain Quality (SCQ)
Company: Ortho-Clinical Diagnostics
Posted on: June 10, 2021
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
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
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).
- 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
- 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
- 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
- Strong working knowledge of applicable regulations (FDA CFR
Part 820, Part 11 regulations, and ISO 13485 standards) is highly
- 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
- Process Excellence Certification (e.g. Black Belt/Green Belt),
Six Sigma, Lean, ISO Lead Auditor, or ASQ CQA/CQE certification and
training are preferred.
Keywords: Ortho-Clinical Diagnostics, Rochester , Staff Quality Engineer, Supply Chain Quality (SCQ), Other , Rochester, New York
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