Engineer II QA
Posted on: November 21, 2022
Requisition ID: 55734 Title: Engineer II QA Division: Arthrex
Manufacturing Inc (US02) Location: Ave Maria, FLArthrex, Inc. is a
global medical device company and a leader in new product
development and medical education in orthopedics. Arthrex is
actively searching for a QA Engineer II for our Ave Maria
Manufacturing site. The QA Engineer II is responsible for
supporting the Quality Manager will all quality related support for
the life cycle development of Class I, II, and III medical devices
including new product development and maintenance of released
products. The successful candidate will have a Bachelors' degree in
Engineering and two years relevant experience. Knowledge of
continuous improvement methodologies along with manufacturing and
inspection processes is preferred. Join our talented team at a
global medical device company focused on Helping Surgeons Treat
Their Patients Better---. Essential Duties and
- Review design drawings for tolerance, inspect-ability and
quality of design issues.
- Work with suppliers to improve quality, and assist, where
necessary, in supplier process validations.
- Assist in the training of QC Inspectors on inspection
techniques and the use of new equipment.
- Participate in Internal and External quality audits as directed
by the Quality Assurance Manager.
- Support Risk Management by leading or participating in
cross-functional team pFMEA's and Risk Assessments.
- Support the AMI Engineering Change Management process by
performing tasks as assigned.
- Lead or Support the internal manufacturing First Article
Inspection process, review First Article Inspection Reports and
samples (internal and/or supplier).
- Lead or Support equipment or process validation (IQ, OQ,
- Lead or support Metrology with design and development of
inspection methods and gages.
- Create or review inspection method work instructions.
- Lead or support Metrology with Measurement System Analysis
(Gage R&R) studies.
- Create Inspection Plans Supporting Receiving and In-Process
- Investigate complaints as requested by the
- Lead completion of Nonconformances (NCR's) as assigned:
material disposition plans, evaluations, and action plans.
- Perform routine Nonconformance and process trending and lead
periodic Quality review meetings with the management team.
- Lead or Support Continuous Improvement projects.
- Lead or support the Environmental Monitoring program.
- Complete Root Cause Analysis Investigations and define
Corrective/Preventive Action Plans (CAPA's).
- Perform Engineering Studies and Design of Experiments (DOE) as
needed. Education and Experience:
- Bachelor's degree in Engineering required.
- 2 years' experience in a Quality Control or Quality Assurance
position, preferably in a Medical Device Company Knowledge and
Skill Requirements/Specialized Courses and/or Training:
- Technical knowledge in development methodologies including:
Design Controls, GD&T, DOE, Process Verification and
- SPC (Statistical Process Control) knowledge.
- Working knowledge of process improvement tools (i.e.: Lean -
PDCA, Six Sigma - DMAIC) and problem solving (i.e.: Kepner Tregoe,
Lean A3, 5 Whys) preferred.
- Working knowledge of risk assessments, PFMEAs, control plans,
- Strong communication skills and ability to communicate
effectively with technical and non-technical staff.
- Project management skills preferred. Machine, Tools, and/or
- Proficiency in the use of PC and programs, particularly Excel,
Word (or equivalents if changed by the Company), miniTab or similar
statistical analysis software, SAP or similar inventory software,
Agile or similar design lifecycle software, Pilgrim or similar QMS
- Knowledge of measurement and other inspection equipment.
- Manufacturing process knowledge Reasoning Ability:
- Ability to define problems, collect data, establish facts, and
draw valid conclusions.
- Ability to interpret an extensive variety of technical
instructions in mathematical or diagram form and deal with several
abstract and concrete variables. Mathematical Skills
- Ability to comprehend and apply mathematical principles to the
degree required to perform the job based upon job requirements.
Prefer working knowledge and application of Statistics. Language
and Communication Skills:
- Ability to comprehend and apply language skills to the degree
required to perform the job based upon the job requirements listed
above. Ability to verbally communicate ideas and issues effectively
to other team members and management. Ability to write and record
data and information as required by procedures. 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
Keywords: Arthrex, Cape Coral , Engineer II QA, Engineering , Immokalee, Florida
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