Principal Quality Systems Engineer
Company: Terumo Medical Corporation
Posted on: August 8, 2022
Job Summary: The Principal Quality Systems Engineer is
responsible for providing quality system leadership and insight
into the global quality system requirements to support the TMC
business as it continues to grow and change. They will collaborate
with key internal business and technical stakeholders to work cross
functionally to improve the overall Terumo (TMC) Quality Management
System and provide sound design approaches to navigate the Quality
System requirements to ensure compliance in a logical and efficient
manner. The Principal Quality System Engineer will be the Subject
Matter Expert for TMC's electronic quality management system. Job
- Develop, design, maintain, and continuously improve the TMC
Quality system in accordance with applicable regulations for a
global medical device corporation.
- Help to streamline the quality system for efficiency,
effectiveness, and compliance.
- Drive the deployment of the quality system to all Terumo
Medical sites and subsidiaries.
- Integrate standard quality system tools for managing the
- Utilize process improvement and problem-solving methodologies
to continuously improve the quality system.
- As the quality system technical lead, support TMC sites and
subsidiaries on compliance and quality system related
- Apply root cause investigation and/or process development tools
(ex: six sigma) to determine changes required.
- Provide quality system expertise to guide teams in implementing
- Work with site personnel to identify root cause and corrective
action plans to improve the quality system.
- Act as the subject matter expert for TMC's electronic quality
management system (eQMS) and electronic document management system
- Implement and maintain a complaint eQMS/eDMS for TMC &
- Drive implementation of new and improved workflows to support
the growing business and/or revised requirements.
- Work with all functional SMEs across all TMC sites &
subsidiaries to ensure the system is effective and efficient.
- Lead work with software vendor to ensure quality system
requirements are met.
- Generate metrics & dashboards to demonstrate the performance of
the quality system.
- Develop and provide training for eQMS/eDMS system as subject
- Oversee the TMC change management process in alignment with 21
CFR Part 820, ISO 13485, and other global medical device
regulations. (EU MDR and multi country)
- Manage the change management process including a portfolio of
projects to ensure they are being managed in a timely and compliant
- Review Change control plans and, as needed, provide guidance,
coaching, and other leadership to help change owners and leaders
develop optimized change control plans and documentation.
- Lead and own the organization and management of the Change
- Support the development of a proactive and preventive quality
systems culture throughout the business.
- Mentor other quality professionals to support the organization
in establishing a high performing team.
- Lead assist and/or conduct internal audits to assess compliance
with applicable regulations and standards (e.g. - Quality System
Regulation (QSR), ISO 13485, ISO 14971, ISO 11607, ISO 11135/
EN550, ISO 11137/ EN552 and the Medical Device Regulation).
- Assist with third party/regulatory audits (Customer, Notified
- Performs other job-related duties as assigned.
Position Requirements: Knowledge, Skills and Abilities (KSAs)
- Quality and business process knowledge:
- Extensive experience with FDA, ISO 13485, EU MDR, and
multi-country Quality Systems requirements.
- Ability to navigate implementing products and processes in an
efficient and compliant manner.
- Demonstrated ability to use process development tools (ex. Lean
- Demonstrated ability to apply a practical level of
- Ability to develop and maintain spreadsheets, pivot tables,
metrics, statistical applications, charts/graphs, and user-friendly
- Demonstrated ability to communicate and interact with all
levels of the organization including Executive Leadership
- Strong interpersonal skills to provide coaching, training, and
- Demonstrated ability to provide clear direction and mentor
- Strong proofreading and writing skills, as well as exemplary
attention to detail
- Demonstrated organizational and prioritization skills
- Exceptional decision-making including the ability to rapidly
understand complex changes and pace work completion to the needs of
- Demonstrated initiative and ability to work independently while
handling multiple tasks
- Strong computer knowledge (MS Office), technical writing skills
and proofreading ability
- Demonstrated ability to work effectively with cross- functional
teams for problem-solving, product and process improvement is
required. Background Experience - B.S. degree or combination of
equivalent education, background, and experience in Scientific or
Engineering discipline required. - Advanced degree preferred. -
Minimum 15 years' overall experience with at least 10 years of
related experience in medical devices/diagnostics, pharmaceutical
or other regulated industry required with a focus on quality system
responsibilities. - Six Sigma certification preferred.
Keywords: Terumo Medical Corporation, Trenton , Principal Quality Systems Engineer, Other , Somerset, New Jersey
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