Supplier Quality Assurance Engineer II 1
Posted on: May 7, 2021
Requisition ID: 47491 Title: Engineer II - Supplier QA Division:
Arthrex, Inc. (US01) Location: Naples, 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
Supplier Quality Engineer to manage and maintain supplier base to
assure products and processes internally and externally meet
specifications and improve supplier product quality performance
resulting from supplier process changes and product resourcing.
This position is responsible for reviewing supplier Production Part
Approval Process (PPAP) documents and for the validation activities
at Arthrex suppliers. Join our talented team at a global medical
device company focused on Helping Surgeons Treat Their Patients
Better---. Essential Duties and Responsibilities:
- Responsible for initiating PPAP Initiation Forms and reviewing
Supplier Part Submission Warrant documents (pFMEA, Process Flow
Diagrams, Process Control Plans, Measurement System Analysis (Gage
R&R), Dimensional Results (FAIR), Capability Studies, etc.) to
ensure compliance to applicable standards (ISO 13485, ISO 17025,
ISO 11737, etc.), regulations (21 CFR Part 820, EU MDR, etc.) and
- Responsible for reviewing Supplier Change Requests (SCR) and
Supplier Proposed Process Changes (SPPC) to ensure continuous
compliance to applicable standards, regulation and internal
- Support manufacturing, engineering, quality assurance, and
quality control process validation related activities.
- Responsible for coordinating laboratory testing in conjunction
with the production process and cleaning validation studies.
- Responsible for performing supplier quality system and process
- Responsible for reviewing design drawings and processes with
suppliers to assure inspectability and compliance.
- Work with suppliers to improve product and process quality and
assist with correlations studies and inspection plans.
- Review supplier processes and process validations to assure
internal and external processes are adequate to meet
- Work with suppliers to assist, where necessary, writing and
executing protocols and conducting validations as needed.
- Responsible for assisting in compiling and reporting on
supplier performance statistics.
- Evaluate and determine reduced or increased inspection plans
based on supplier performance and controls.
- Initiate and assist suppliers with Corrective and Preventive
Actions and assure actions are adequately closed.
- Train and/or assist supplier quality personnel in inspection
techniques and the use of new equipment.
- Assist in the design and development of methods and tooling for
the test and inspection of articles.
- Work with supplier to ensure that suppliers operate in
accordance with established requirements.
- Write and/or assisting in writing of work instructions in
conjunction with suppliers.
- Responsible for assisting in complaint investigations as
related to product quality from suppliers.
- Drive system improvement activities.
- This role requires travel up to 25% of the time. Incidental
Duties: 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 Technology discipline. At least three
years experience required, preferably in a Quality Control or
Quality Assurance position in a Medical Device Company or
Automotive Industry with strong PPAP experience. Knowledge and
Skill Requirements/Specialized Courses and/or Training: Experience
with 21CFR 820 or ISO 13485 and Production Part Approval Process
(PPAP). Knowledge of testing equipment, production processes,
statistical methods, control plans. Machine, Tools, and/or
Equipment Skills: Proficiency in the use of PC and programs,
particularly Excel, Word (or equivalents if changed by the
Company), SAP or similar inventory software. 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 , Supplier Quality Assurance Engineer II 1, Other , Naples, Florida
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