Sr 1 Quality Engineer - Manufacturing
Posted on: January 13, 2022
Requisition ID: 49540 - Title: Sr 1 Quality Engineer -
Manufacturing - Division: Arthrex Manufacturing Inc (US02) -
Location: Ave Maria, FL
Arthrex is a global medical device company and a leader in new
product development and medical education in orthopedics. Arthrex
is actively seeking a Sr 1 Quality Engineer - Manufacturing who
works directly with the Manufacturing & Quality Engineering teams
within Arthrex. You will be responsible for ensuring the
suitability and effectiveness of the Arthrex manufacturing site QMS
by measuring and monitoring process effectiveness, driving and
implementing improvements to QS processes, facilitating CAPAs and
CAPA Review Board, administration and maintenance of internal and
external audits, investigation/resolution of quality issues, and
development of QS processes. Excellent communications and
analytical skills, strong technical project management skills and a
Bachelors' degree in Engineering or Engineering Technology
discipline will be essential for this position. Join our talented
team at a global medical device company focused on Helping Surgeons
Treat Their Patients Better---.
Essential Duties and Responsibilities:
Participates in the development of medical devices and components
from design initiation through design transfer and by representing
Quality Assurance for manufacturability in all design and
development project teams.
Participates in all manufacturing activities to assure compliance
of design specifications.
Leads development of quality plans of new product introductions
based on design specifications, PFMEA, and control plans.
Works with design team and assist/provide feedback on design
specifications and improvements.
Evaluates and develops effective and efficient methods of testing
and inspection of products.
Utilizes problem solving tools and techniques and apply risk based
approach to problem solving.
Determines necessity of testing and initiates testing by preparing
test and inspection plans and identifying and obtaining required
test fixtures and test/inspection instrumentation.
Initiates new projects and acts as the project leader for key
initiatives, identifies best practices.
Provides technical support on manufacturing technical issues.
Performs quality trending and leads/supports process improvement
Approves manufacturing product and process changes and assures the
change management is controlled, adequate, and documented.
Ensures information and documentation is consistently accurate.
Responsible for MRB activities for assigned products, timely
resolution of nonconformities, issuing and/or monitoring corrective
actions associated with nonconformance and deviations.
Provides input and direction to other members of the quality
assurance department to assist them in their assignments and
provide them with learning experience.
Supports manufacturing suppliers with assistance in on-site
resolution of quality and process related issues and corrective and
May supervise other engineers, technicians, and support
This is an in-office position located in Ave Maria, Florida; it is
not a remote position."
The above statements describe the general nature and level of work
being performed in this job. - They are not intended to be an
exhaustive list of all duties, and indeed additional
responsibilities may be assigned, as required, by management.
Education and Experience:
Bachelor's degree required -in an Engineering or Engineering
5 years experience in a Quality Control or Quality Assurance
position required, preferably in a medical device company.
Knowledge and Skill Requirements/Specialized Courses and/or
Working knowledge of risk assessments, design control requirements,
PFMEAs, control plans, quality plans, testing and inspection
equipment and techniques.
Manufacturing process knowledge.
Technical knowledge in development methodologies, design, project
implementation, including, but not limited to GD&T, DOE,
verification, and validation.
SPC (Statistical Process Control) knowledge.
Strong communication skills and ability to communicate effectively
with technical and non-technical staff.
Project management skills preferred.
Recognized process improvement (i.e.: Lean, Six Sigma) and problem
solving (i.e.: RCA, DMAIC, 5 Whys) training preferred.
All qualified applicants will receive consideration for employment
without regard to race, color, religion, age, sex, sexual
orientation, gender identity, national origin, disability or
protected veteran status.
Keywords: Arthrex, Cape Coral , Sr 1 Quality Engineer - Manufacturing, Engineering , Immokalee, Florida
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