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QA Rotational Engineer in Naples, FL ,  at Arthrex

Date Posted: 1/31/2019

Job Snapshot

  • Employee Type:
    Full-Time
  • Location:
    Naples, FL
  • Job Type:
  • Experience:
    Not Specified
  • Date Posted:
    1/31/2019

Job Description


Requisition ID:
41492
Title:
QA Rotational Engineer
Division:
Arthrex, Inc.
Location:
Naples, FL

This role is meant for a new Engineering Grad to come in and be exposed to all areas of our Quality Engineering processes.  If you are a new grad with an Engineering Degree please take a look at this new program!

Main Objective:

This is a rotational program for the Global QA and RA departments.  The scope of the rotation is limited to Florida, to include Arthrex INC, AMI, and ALC.  The associate is responsible for supporting the QA/RA Departments with quality related support for improving and maintaining the Arthrex global Quality Management System (QMS) to ensure compliance to FDA QSR, ISO 13485, and all other applicable regulatory requirements.  This is to be accomplished developmentally by working in various sectors of QA/RA, to include Product Surveillance, Quality Systems and Regulatory Compliance, Pre-Production Quality, Supplier Quality, Regulatory Affairs, and Manufacturing Quality Engineering.

Essential Duties and Responsibilities:

Quality Systems and Regulatory Compliance:

  1. Coordinate external audits with auditors and business/process owners from the audit schedule to closing meetings.
  2. Coordinate closures of Corrective Actions and Preventive Actions with responsible parties to assure adequate closure in timely manner. 
  3. Review the responses to Corrective Actions and Preventive Actions to assure compliance and completeness to the findings.
  4. Maintain and manage log of activities for Corrective Actions and Preventive Actions.
  5. Participate in Internal Audits as directed.

Product Surveillance:

  1. Conduct complaint evaluations and investigations and ensures all findings are properly documented.
  2. Evaluate and test returned product according to established specifications, drawings, and procedures.
  3. Collect and record data in appropriate formats as part of continuous improvement.
  4. Works with various Engineering teams to facilitate complaint investigations based on technical complexity and determine non-conformance root cause(s).
  5. Work with vendors to ensure vendor evaluations and investigations are timely and complete.
  6. Provide statistical analysis of data for complaint trending and product improvement.
  7. Identify, collect and analyze data to support the company commitment to quality products.

Manufacturing Quality Engineering:

  1. Participate in the AMI Change Order (CO) and Inc Engineering Change Order (ECO) processes
  2. Review design drawings for tolerance, inspect-ability and quality of design issues
  3. Work with suppliers to improve quality
  4. Assist in the design and development of methods and tooling for the test and inspection of articles
  5. Write and/or assist in the writing of test and inspection SOPs
  6. Assist in complaint investigations as related to product quality
  7. Perform evaluations and create disposition plans for Nonconformances
  8. Assist in determining direct or root causes for assigned issues related to NCRs and CAPAs
  9. Assist in compiling trend analysis data for periodic meetings/reviews

Supplier Quality:

  1. Review supplier processes and process validations to assure internal and external processes are adequate to meet specification
  2. Assist in complaint investigations as related to product quality from suppliers.
  3. Coordinate Supplier Proposed Process Changes (SPPC) to ensure the appropriate Supplier Quality Engineer is assigned and communicates recept and approval to the supplier.
  4. Ensure that the Approved Supplier List is updated based on new supplier additions or qualifications as well as ensuring supplier QMS Certifications are up to date in both the supplier history file and the ASL.
  5. Work with Suppliers to identify root cause and corrective actions when necessary
  6. Assist in conducting supplier audits and follow up of nonconformances

Regulatory Affairs:

  1. Gather information and data from other departments and external resources for regulatory submissions
  2. Organize and maintain workflows, processes, and files/databases
  3. Construct, edit, and assemble regulatory documentation for regulatory submissions

Pre-Production Quality:

  1. Create, manage, and maintain device risk management files and associated documentation in accordance with the requirements of ISO 14971 and global regulatory requirements part of the device design process
  2. Support the design and manufacturing teams in the generation of risk source documentation, e.g., dFMEA, pFMEA, Fault Tree Analysis, etc.
  3. Participates with multifunctional new product project teams in developing risk assessments, design inputs, test and inspection procedures, acceptance criteria and complaint analysis
  4. Facilitate design for manufacture, test and successful design transfer to ensure that new products shall meet specification/requirements
  5. Resolves and/or facilitates the resolution of problems including identifying causes to prevent reoccurrence
  6. Supports/reviews design history file deliverables for assigned projects, completion and adherence to design control procedures

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 in Engineering.
  • 0-2 years’ experience in an FDA/ISO regulated environment

Knowledge and Skill Requirements/Specialized Courses and/or Training:

Working knowledge of ISO 13485 and 21 CFR part 820 – Quality System Regulations is preferred.

Machine, Tools, and/or Equipment Skills:

Proficiency in the use of PC and programs, particularly Excel, Word,Power Point.

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.