Senior Quality Engineer
Company: Stryker Group
Posted on: February 22, 2021
Who we want
Dedicated achievers.--People who thrive in a fast-paced environment
and will stop at nothing to ensure a project is complete and meets
regulations and expectations.
Goal-oriented developers.--Keeping the customer and system
requirements squarely in focus, people who deliver safe and robust
Collaborative partners.--People who build and leverage
cross-functional relationships to bring together ideas,
information, use cases, and industry analyses to develop best
practices. Self-directed imitators. People who take ownership of
their work and need no prompting to drive productivity, change, and
outcomes. User-focused creators. People who imagine with the user
in mind, developing technology that helps change patients' lives.
What you will do As a Senior Quality Engineer in working
partnership with the Global Supplier Network, you'll be involved in
the ongoing support for the internal business units to address
ongoing supplier quality issues, development of suppliers and
ensuring that our external supply chain are capable of meeting
expectations from a quality, service and cost perspective. You will
serve as liaison between suppliers and Stryker to drive effective
continuous improvement as a result of the supplier base. You will
work with internal customers and suppliers in support of supplier
quality issues; provide technical support for activities related to
supplier quality system assessment and performance evaluation. You
will collaborate with the strategic sourcing, auditing and
development groups to understand the capabilities and competencies
of suppliers to meet our requirements and continually meet and
adapt to our product quality and regulatory requirements. This role
will provide coaching and guidance to the SQE team to ensure
compliance to technical, regulatory and Stryker requirements. This
person will also act as the Single Point of contact for
communication of issues for the suppliers within their commodity
- Work closely with operations and the business functions to
ensure quality performance of product and processes.
- Collaborate with Divisional QA, cross-functional and suppliers
teams to address top quality issues.
- Ownership for supplier quality performance and measurement
including KPI's and participate in supplier performance reviews.
Enable reporting of metrics for monthly reviews.
- Lead quality issues with suppliers & partner with Internal
Customers; Lead effective supplier containment and
- Lead CAPA projects and manage to timely root cause
investigation, implementation and closure.--
- Lead internal and supplier driven non-conformances and manage
the timely closure of NC's.
- Apply statistical methods of analysis and process control to
current operations in support of management review, CAPA, and other
quality system processes
- Act as point of contact for Internal/ External Customer groups
on key compliance issues related to assigned suppliers.
- Participate in External Audits and Internal Audits as needed.
Ensure Regulatory compliance in area of responsibility to GMP of
all medical devices regulatory agencies (i.e. FDA, IMB, Notified
- Responsible for accuracy and integrity of supplier data that
ensures compliance with documented procedures & processes.
- Ownership and reporting on all quality issues associated with
the Global Quality Organization.
- Participate in the supplier material related processes which
include: Material Review Board to ensure Coordination of MRB
activities with the business unit to ensure the timely assessment
of potential non-conforming products.
- Develop understanding of risk management practices and concepts
and applies knowledge to manufacturing operations.
- Maintain structured communication channels with strategic
sourcing, identifying responsibility by commodity / supplier.
- Liaising with the Manufacturing and Quality groups, in
assessing and addressing material quality issues with assigned
- Maintenance of the--Approved Supplier List (ASL) in conjunction
with the Global Sourcing, Supplier Controls and Audit
- Support the creation and maintenance of inspection methods and
- Support the development and review of process and equipment
validation/qualification and MSA of internal processes.
- Execute internal quality deliverables associated with
engineering changes, manufacturing transfers and supplier initiated
- Support manufacturing transfers to/from other
plants/facilities, executing appropriate quality activities.
- Participate as required in SCRB in conjunction with key
- Support assessment of supplier changes.
- Participate in supplier reviews for assigned suppliers as
- Participate in cross functional projects both locally &
globally as required.
- Partner with SQM functions and Strategic Sourcing on the
developments and approval quality assurance agreements with
suppliers. What you need Basic Qualifications:
- Bachelor's Degree
- Minimum 3 years' experience in quality, manufacturing or
engineering Preferred Qualifications:
- Technical Degree in relevant field desired
- Knowledge with GMP, ISO 13485, 21 CFR Part 820 standards
- Knowledge of FMEA, Validation Programs and SPC processes in a
highly regulated environment
- Demonstrated working knowledge to positively influence supplier
- Preferred industries are medical device, aviation, aerospace,
automotive and defense
- Internal Quality Auditor Qualification either in AS 9100 or
ISO13485, CFR820 or comparable industry standards and regulatory
requirement Joining our talent network will enhance your job search
and application process. Whether you choose to apply or just leave
your information, we look forward to staying connected to you.
Keywords: Stryker Group, Leesburg , Senior Quality Engineer, Engineering , Leesburg, Virginia
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