Supplier Quality Engineer
Company: TeDan Surgical Innovations
Location: Sugar Land
Posted on: May 12, 2022
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Job Description:
Company description: TeDan Surgical Innovations (TSI) designs
and manufactures specialty surgical products for use in orthopedic,
neuro, thoracic and spine surgeries. TSI was founded in 2006 with
the goal to innovate and address evolving retraction techniques in
spine surgery. We have successfully addressed the need for
minimally invasive, posterior, lateral and anterior surgical
approaches to the spine, and have introduced access instrumentation
for neurological, orthopedic and cardiothoracic procedures. We
commit to providing innovative, high-quality surgical access
systems designed to optimize exposure and improve the surgeon
experience. Job Summary: The Supplier Quality Engineer (SQE) will
be responsible for providing Quality Engineering support and
leadership for day-to-day operations of Supplier Management and
activities relating maintaining Approved Supplier List, supplier
selection, evaluation, and performance. This position partners
closely with subject matter experts to identify, investigate and
resolve product non-conformances while supporting continuous
improvement initiatives. The position requires continuous on-site
support to internal stakeholders such as RAQA, Operations and
Purchasing. Duties/Essential Job Functions: Manage supplier quality
performance to achieve organizational quality objectives. Own and
report supplier quality issues. Maintain the Approved Supplier List
(ASL) through review and approval of new supplier requests, change
requests, and supplier selection plans. Develop, implement, and
maintain appropriate metrics to assess supplier performance.
Initiate and manage supplier corrective action requests (SCARs) to
ensure effective problem resolution by suppliers. Trend,
investigate, and ensure completion of supplier non-conformances.
Partner with Operations, through communications with suppliers,
regarding Quality Control issues with processes and/or products.
Develop and maintain supplier audit schedule.; perform supplier
audits as required. Drive root cause analysis of product quality
issues and implement solutions to resolve the issues; assist other
personnel, as required, with the Corrective Action process for
purchased product and/or services. Support TSI audit team during
audits (i.e. FDA, Notified Body, Customer, Supplier, Internal).
Generate and maintain responsibility for Supplier Quality
Agreements that align with TSI expectations for the manufacture of
TSI products to ensure compliance with current standards, guidance
documents, and regulations for the sale of product in the US and
OUS as applicable. Maintain up-to-date documentation for supplier
files, including but not limited to: quality standards/regulatory
certifications, regulatory information (including FDA registration
information, UDI information, GMDN codes, etc.), standards
operating procedures, quality manual, manufacturing flow charts,
process validations, and identification of all sites, including
sub-contractors, where manufacturing activities are performed.
Other responsibilities assigned by supervisor include, but not
limited to: vendor site audits, general corporate functions
associated with role as Quality Engineering professional.
Knowledge/Skills/Experience: 5 years--- experience within regulated
medical device / pharmaceutical industry in as Supplier Quality
Engineer (SQE) Demonstrated knowledge of FDA regulations, ISO 9001,
ISO 13485, CMDR, Medical Device Directive Regulation (93/42EEC), EU
MDR 2017/745, and other National and International regulations and
standards Demonstrated ability to manage, plan, organize and
implement multiple concurrent and competing priorities in a
fast-paced environment Excellent independent problem-solving,
organizational, analytical and critical thinking skills with the
ability to handle multiple tasks in a fast-paced environment
Understanding and implementation of statistical techniques Strong
technical writing skills and ability to create technical reports as
well as manufacturing / inspection procedures with strict attention
to detail Experience with change control, CAPA and deviation
quality systems High level of computer skills Communication:
Ability to internally and externally discuss and clearly define key
technical and process issues and independently develop course of
actions/plan Business Acumen: Require a basic understanding of
business and financial impact of product Teamwork: Must be able to
work in a team environment. Pursue trust for each team member. Seek
and deliver honest feedback to all team members. Committed and
accountable to achieving team goals. Abide by team decisions.
Adhere to all company rules and requirements (e.g., pandemic
protocols, Environmental Health & Safety rules) Required Education:
Bachelor of Science (B.S.) degree in Biomedical, Mechanical or
Materials Engineering with experience in the medical device
industry Physical Requirements: Business casual attire.
Occasionally requires attending corporate functions. Occasionally
may require travel (5-10%) Job Type: Full-time Benefits: 401(k)
Dental insurance Flexible spending account Health insurance Life
insurance Paid time off Parental leave Tuition reimbursement Vision
insurance Schedule: Monday to Friday
Keywords: TeDan Surgical Innovations, Sugar Land , Supplier Quality Engineer, Engineering , Sugar Land, Texas
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