Engineer II - QA

Arthrex, Inc. is a global medical device company and a leader in new product development and medical education. Arthrex is actively searching for a Quality Assurance Engineer II to support our continued growth at our Pendleton, SC manufacturing facility. The successful candidate will have previous quality engineer experience in a machining environment. Excellent interpersonal and communication skills along with two years or more of related experience and a Bachelor’s degree in Engineering or Engineering Technology are essential for this position. Join our talented team at a global medical device company focused on Helping Surgeons Treat Their Patients Better™.

Main Objective:

Responsible for supporting the Quality Manager with 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.

Essential Duties and Responsibilities:

1. Review design drawings for tolerance, inspect-ability and quality of design issues.
2. Work with suppliers to improve quality, and assist, where necessary, in supplier process validations.
3. Assist in the training of QC Inspectors on inspection techniques and the use of new equipment.
4. Participate in Internal and External quality audits as directed by the Quality Assurance Manager.
5. Support Risk Management by leading or participating in cross-functional team pFMEA’s and Risk Assessments.
6. Support the AMI Engineering Change Management process by performing tasks as assigned.
7. Lead or Support the internal manufacturing First Article Inspection process, review First Article Inspection Reports and samples (internal and/or supplier).
8. Lead or Support equipment or process validation (IQ, OQ, PQ)
9. Lead or support Metrology with design and development of inspection methods and gages.
10. Create or review inspection method work instructions.
11. Lead or support Metrology with Measurement System Analysis (Gage R&R) studies.
12. Create Inspection Plans Supporting Receiving and In-Process Inspection.
13. Investigate complaints as requested by the Complaints/Reliability team.
14. Lead completion of Nonconformances (NCR’s) as assigned:  material disposition plans, evaluations, and action plans.
15. Perform routine Nonconformance and process trending and lead periodic Quality review meetings with the management team.
16. Lead or Support Continuous Improvement projects.
17. Lead or support the Environmental Monitoring program.
18. Complete Root Cause Analysis Investigations and define Corrective/Preventive Action Plans (CAPA’s).
19. Perform Engineering Studies and Design of Experiments (DOE) as needed.
20. Other duties as assigned.

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 preferably in an Engineering or Engineering Technology. 
• 2 years experience in a Quality Control or Quality Assurance position in a Medical Device Company preferred.

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

• Technical knowledge in development methodologies including: Design Controls, GD&T, DOE, Process Verification and Validation.
• 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, quality plans. 
• Strong communication skills and ability to communicate effectively with technical and non-technical staff.
• Project management skills preferred.

Machine, Tools, and/or Equipment Skills:

• 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 software.
• 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.

Physical Demands:

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of the job.  Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.  While performing the duties of this job, the employee is regularly required to talk or hear.  The employee is frequently required sit; use hands and fingers, to handle, or feel; and reach with hands and arms. The employee must occasionally lift and/or move up to 10 pounds. 

Vision Requirements:

Visual acuity necessary to do the job safely and effectively.  

Specific vision abilities required by this job include close vision using a microscope and light source.

Work Environment:

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job.  Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.  The area that this job is performed in is a general office or open cubicle/workstation environment.  The noise level in the work environment is usually moderate.

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.