Quality Engineer
Company: BEBIG Medical
Location: Mount Vernon
Posted on: July 29, 2022
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Job Description:
This is a best chance to help save lives and provide affordable
healthcare for everyone with your own expertise.We are now looking
for candidate at below position for Mick Radio-Nuclear
Instruments., Inc, our US Subsidiary of BEBIG Medical GmbH, a
global supplier of radiation therapy medical device company. We
have offices in Berlin, New York, Shanghai, Singapore and India
with customers across more than 70 countries and regions.If you are
interested in, please kindly send your CV to:
hr@bebigmedical.comPosition: Clinical Application Specialist Main
Tasks:--- Supports company goals and objectives, policies and
procedures in compliance with the quality management system, FDA,
Canadian, ISO and International regulation/requirements.---
Develop, execute and maintain technical documentation such as
510(k)'s, design history files (DHF's), device history and master
records (DHR's/DMR's), IQ/OQ/PQ plans and protocols associated with
product/process quality according to but not limited to FDA,
Canadian, ISO regulations and company specific SOP's.--- Write up,
review and revise qualification measurement system analysis
(MSA's), Standard Operating Procedures (SOP's), Statistical Process
Control (SPC's) and Failure Modes and Effects Analysis (FMEA).---
Provides quality engineering support to manufacturing and product
development groups. Works closely with Operations and Engineering
to develop and implement appropriate risk management,
qualification, verification/validation plans.--- Assesses and
provides recommendations for improvement of processes and equipment
for compliance to cGMP and current ISO 13485 regulations within the
Manufacturing, Quality & Regulatory processes to ensure safe and
effective products are produced. Provides written reports and
supporting documentation for recommendations.--- Reviews ECR's to
ensure compliance to Quality Management System, FDA, Canadian, ISO
and other International requirements (as needed) for new and
current products.--- Supports the CAPA process, collaborating with
owners to ensure effective root cause analysis and the development
of innovative, long-term solutions.--- Tracks effectiveness of
corrective action plans and compliance improvement initiatives.---
Ensures accurate project schedules are maintained and communicated
to both internal and external management.--- Maintain Internal
Audit and Calibration programs per FDA Part 820 and ISO 13485
standards.--- Responsible for performing and reporting on
Supplier/Vendor Quality Audits.--- Carry out other reasonable tasks
as required by the Chief Operating Officer.Requirements:---
Bachelor of Science (BS) degree in Biomedical or Mechanical
Engineering - (other science based technical degrees will be
considered) with a minimum of 7 years of Quality/Regulatory
experience in the medical device/pharmaceutical industry, or---
MUST have thorough understanding of Current Good Manufacturing
Practices, Quality Systems, Regulatory Requirements, Validation
Principles and Manufacturing Methods in a Medical
Device/Pharmaceutical regulated environment (demonstrated knowledge
and application of quality system regulations - 21CFR820, MDD, ISO
- 13485, ISO - 14971 and other international standards). --- Strong
technical writing skills and ability to create technical protocols
and reports as well as manufacturing inspection procedures.---
Understanding of inputs, outputs, raw materials, waste, quality
control, costs, and techniques for maximizing the manufacture and
distribution of goods.
Keywords: BEBIG Medical, Mount Vernon , Quality Engineer, Engineering , Mount Vernon, New York
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