Engineer Sr. II QA Supplier FL

2 months ago

Naples FL United States Arthrex Full time

Arthrex, Inc. is a global medical device company and a leader in new product development and medical education. We are a privately held company that strives to accomplish our corporate mission of Helping Surgeons Treat Their Patients Better™. We are committed to delivering uncompromising quality to the health care professionals who use our products, and ultimately, the millions of patients whose lives we impact.
Arthrex Benefits
Medical, Dental and Vision Insurance
Company-Provided Life Insurance
Voluntary Life Insurance
Flexible Spending Account (FSA)
Supplemental Insurance Plans (Accident, Cancer, Hospital, Critical Illness)
Matching 401(k) Retirement Plan
Annual Bonus
Wellness Incentive Program
Free, Onsite Medical Clinics
Free Lunch
Tuition Reimbursement Program
Trip of a Lifetime
Paid Parental Leave
Paid Time Off
Volunteer PTO
Employee Assistance Provider (EAP)
Please note, most benefits are for regular, full time employees.
All qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other status protected by law.


Arthrex, Inc. is a global medical device company and a leader in new product development and medical education in orthopedics. Arthrex is actively searching for an Engineer Sr. II, QA Supplier Quality who is responsible for managing and maintaining our supplier base to assure products and processes internally and externally meet specifications, improve supplier product quality performance, and determine adequate receiving inspection plan. Join our talented team at a global medical device company focused on Helping Surgeons Treat Their Patients Better™.

Essential Duties and Responsibilities:

  • Responsible for reviewing design drawings and processes with suppliers to assure inspectability and compliance.
  • Work with suppliers to improve product and process quality through onsite workshops, development of PFMEAs / Control Plans, and assist with correlations studies and inspection plans.
  • Review and engage with supplier process improvements, process validations, supplier-initiated change notifications, and FAI expectations to assure internal and external processes are adequate to meet specification.
  • Work with suppliers to assist, in writing and executing protocols and conducting process validations per internal requirements.
  • Responsible for supplier qualifications including use and development of questionnaires, audit plans, conducting supplier audits, and engaging with suppliers toward closure of audit findings.
  • Gather and review supplier Maintenance Repair or Operating (MRO) material list to assure product risk is mitigated.
  • Responsible for and assisting in compiling and reporting on supplier performance metrics / 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 assist in writing and developing of quality management system processes, work instructions, and forms in conjunction with suppliers and internal purchasing control requirements.
  • Responsible for assisting in complaint investigations as related to product quality from suppliers.
  • This role requires travel up to 50% of the time.

 

Education and Experience:

  • Bachelor’s degree in Engineering or Engineering Technology required
  • 8+ years experience required, preferably in a Quality Control or Quality Assurance position in a Medical Device Company.

 

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

Experience working within the guidelines of a Quality Management System.  Knowledge of testing equipment, statistical methods, validation methods, problem solving, and 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), PowerPoint, Visio, Minitab, Outlook, and, SAP or similar ERP software.

 

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. 

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 lead technical discussions with a focus on cross-functional buy-in and results.  Ability to interact productively with internal stakeholders as well as suppliers.  Ability to scope project requirements working cross-functionally establishing actions, timelines, and ownership.

Arthrex Benefits

  • Medical, Dental and Vision Insurance
  • Company-Provided Life Insurance
  • Voluntary Life Insurance
  • Flexible Spending Account (FSA)
  • Supplemental Insurance Plans (Accident, Cancer, Hospital, Critical Illness)
  • Matching 401(k) Retirement Plan
  • Annual Bonus
  • Wellness Incentive Program
  • Free Onsite Medical Clinics
  • Free Onsite Lunch
  • Tuition Reimbursement Program
  • Trip of a Lifetime
  • Paid Parental Leave
  • Paid Time Off
  • Volunteer PTO
  • Employee Assistance Provider (EAP)

All qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other status protected by law.

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