Quality Engineer II Product Surveillance

2 weeks ago

Naples, 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 a Quality Engineer II, Product Surveillance who is responsible for driving product improvements through performing and supporting Product Quality Complaint evaluations and investigations, analyzing and trending Product Quality Complaint data, and providing timely customer feedback to key stakeholders.  The ideal candidate will have a Bachelor’s degree in Engineering and 2+ years’ experience with root cause analysis, project management and continuous improvement in a regulated environment.

Join our talented team at a global medical device company focused on Helping Surgeons Treat Their Patients Better™.

Essential Duties and Responsibilities:

  • Develop and promote the Arthrex Product Surveillance processes for medical devices, including developing, managing and maintaining global policies and procedures.
  • Perform root cause analysis for returned complaint devices or identified trends as appropriate.
  • Maintain test protocols to evaluate returned product according to established specifications and record detailed results. Perform device evaluations when needed.
  • Partner with Design Engineering, Manufacturing Engineering, Product Management, and Quality Engineering teams to drive continuous process and product improvement.
  • Function as the global representative for complaint investigation, escalation, and trending processes during Agency/3rd Party Audits and assists in the preparation and submission of audit responses and requests for information to FDA, Notified Body and other Regulatory Bodies.
  • Provide timely customer feedback to key stakeholders through root cause analysis, statistical analysis and regularly scheduled forums.
  • Support global complaint triage, intake, evaluation, reporting, investigation, closure and trending activities.
  • Manage supplier relationships from initial notification to receipt of a supplier complaint evaluation.

Education and Experience:

  • Bachelor’s degree in Engineering or Engineering Technology required.
  • 2+ years’ experience with root cause analysis, project management and continuous improvement in a regulated environment.

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

  • Knowledgeable of Regulatory and ISO guidelines for the development of medical devices required.
  • Knowledgeable of medical device complaint handling and adverse event reporting requirements preferred.
  • Knowledgeable of product risk management, CAPA, and Nonconformance Reporting preferred.
  • Knowledgeable of orthopedic medical devices including implants, instruments, biologics, and electronical equipment preferred.

Machine, Tools, and/or Equipment Skills:

Proficiency in the use of Personal Computers and computer programs, particularly the Microsoft Office Suite; Excel, Word, PowerPoint (or equivalents if changed by the Company).  SAP and / or SmartSolve Quality Data experience desirable.

Reasoning Ability:

Ability to identify opportunities, collect data, analyze established facts, draw valid conclusions, and implement change.  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 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 frequently bend and lift/move up to 10 pounds.  The employee must occasionally bend and lift/move up to 50 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.  While performing the duties of this job, the employee is occasionally exposed to moving mechanical parts, fumes or airborne particles, toxic or caustic chemicals, and risk of electrical shock.  The noise level in the work environment is usually moderate.

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.

  • Quality Engineer II Product Surveillance

    3 weeks ago

    Naples, 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...

  • Engineer II Quality Event Managementield Safety

    3 weeks ago

    Naples, 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...

  • Engineer II Quality Event Managementield Safety

    1 week ago

    Naples, 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...

  • Sr. Engineer II- Electrical Product Development

    2 months ago

    Naples, Florida, United States Arthrex, Inc. Full time

    Requisition ID: 59597 Title: Sr. Engineer II- Electrical Product Development Division: Arthrex, Inc. (US01) Location: Naples, FLArthrex, Inc. is a global medical device company leader in new product development and medical education in orthopedics. We are actively searching for an experienced Senior Electrical Engineer II, who will be r esponsible for full...

  • Quality Inspector

    4 weeks ago

    Naples, United States Progress Rail Services Full time

    9762BR PRS Facility Location: Naples, FL - 315 Job Purpose: Reports directly to and works under the supervision of the QA Supervisor/Manager. A QA Inspector I has the capability to train on all levels use computer related functions perform visual and/or test inspection of a QA Inspector II or III. Perform other functions or assist in other departments as...

  • Sr. Engineer II

    4 weeks ago

    Naples, 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...

  • Product Development

    2 weeks ago

    Naples, United States Arthrex Full time

    Requisition ID: 60504 Title: Business Systems Analyst II 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 Business Systems Analyst II-Engineering Technologies works directly with the New Product...

  • Quality Assurance Inspector

    7 days ago

    Naples, Florida, United States Progress Rail Services Full time

    Job Title:Quality InspectorJob Overview:The Quality Inspector is responsible for ensuring that products meet the required standards of quality and safety. This role involves direct reporting to the QA Supervisor/Manager and may include training opportunities across various levels of inspection. The inspector will engage in visual and test inspections and may...

  • Quality Inspector

    2 weeks ago

    Naples, United States JobsRUs.com Full time

    JobsRUs.comis seeking to hire a Quality Inspector for our client in Naples FL!Weekly Pay! $31.00/HourShift Details:7:00AM - 3:30PMDESCRIPTION:With minimum guidance in a team environment, using independent judgement to determine quality and usability, responsible for a wide variety of complex inspection requirements.RESPONSIBILITIES:Responsibilities may...

  • Quality Inspector

    2 weeks ago

    Naples, United States JobsRUs.com Full time

    is seeking to hire a Quality Inspector for our client in Naples FL!Weekly Pay! $31.00/HourShift Details:7:00AM - 3:30PMDESCRIPTION:With minimum guidance in a team environment, using independent judgement to determine quality and usability, responsible for a wide variety of complex inspection requirements.RESPONSIBILITIES:Responsibilities may include some or...

  • Quality Assurance Specialist

    14 hours ago

    Naples, Florida, United States Amtec Full time

    Job SummaryAmtec is seeking a highly skilled Quality Inspector to join our team. As a Quality Inspector, you will be responsible for ensuring the quality of our products by conducting inspections and tests to ensure they meet our high standards.Key ResponsibilitiesConduct inspections and tests on complex parts using a wide variety of measuring and test...

  • Quality Assurance Inspector

    2 weeks ago

    Naples, Florida, United States Progress Rail Services Full time

    Job Title:Quality InspectorJob Overview:The Quality Inspector operates under the guidance of the QA Supervisor/Manager, ensuring adherence to quality standards and protocols. This role involves training across various levels and executing visual and testing inspections.Company Overview:Progress Rail Services is a leader in the rail industry, committed to...

  • Parker - Quality Admin (Quality Engineer Intern)

    3 weeks ago

    Naples, United States First Tek Full time

    Roles and Responsibilities:1. Scope: The purpose of this statement of work (SOW) is to define the work scope tasked for a Quality Engineer in support of the Naples Quality team.2. Deliverables/Requirements:•Generation and/or creation and assembly of necessary documentation, in support of all First Article Test Reports as requested by the customer or driven...

  • Product Manager, Spine

    2 weeks ago

    Naples, United States Arthrex, Inc. Full time

    Requisition ID: 60081 Title: Product Manager, Spine Division: Arthrex, Inc. (US01) Location: Naples, FLArthrex, Inc. is a global medical device company and a leader in new product development and medical education within the orthopedic field. Our dynamic team is actively searching for a Product Manager, Spine, to expand our product portfolio. The...

  • Quality Inspector

    2 weeks ago

    Naples, United States Umanist Staffing LLC Full time

    Job DescriptionJob DescriptionRPO HirePay Range based on experience *** - ***Yearly Bonus7am - 3:30pmMUST ATTACH GAGE COMPENTENCY LIST W/RESUME (*** knows no one will have all the experience but knowing their experience will help when interviewing)POSITION SUMMARY:With minimum guidance in a team environment, using independent judgement to determine quality...

  • Quality Inspector

    2 weeks ago

    Naples, United States NR Consulting Full time

    Job Title: Quality Inspector I Location: Naples FL Position Type: RPO Hire Shift timings: 7am - 3:30pm MUST ATTACH GAGE COMPENTENCY LIST W/RESUME Position Summary: With minimum guidance in a team environment, using independent judgement to determine quality and usability, responsible for a wide variety of complex inspection requirements. Responsibilities: -...

  • Quality Inspector

    1 week ago

    Naples, United States NR Consulting Full time

    Job Title: Quality Inspector I Location: Naples FL Position Type: RPO Hire Shift timings: 7am - 3:30pm MUST ATTACH GAGE COMPENTENCY LIST W/RESUME Position Summary: With minimum guidance in a team environment, using independent judgement to determine quality and usability, responsible for a wide variety of complex inspection requirements. ...

  • Software QA Engineer II AR/Unity

    2 days ago

    Naples, 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...

  • Parker - Quality Admin (Quality Engineer Intern)

    2 months ago

    Naples, United States First Tek Full time

    Roles and Responsibilities: 1. Scope: The purpose of this statement of work (SOW) is to define the work scope tasked for a Quality Engineer in support of the Naples Quality team. 2. Deliverables/Requirements: • Generation and/or creation and assembly of necessary documentation, in support of all First Article Test Reports as requested by the customer or...

  • Quality Inspector

    2 weeks ago

    Naples, United States Amtec Global Solutions Inc Full time $27 - $31

    Job DescriptionJob DescriptionDescription:Direct HirePay Range: $27 - $31Yearly Bonus7am - 3:30pmPOSITION SUMMARY:With minimum guidance in a team environment, using independent judgement to determine quality and usability, responsible for a wide variety of complex inspection requirements.RESPONSIBILITIES:- Responsibilities may include some or all of the...