Apply on Employer Site

Arthrex · 4 hours ago

Sr. Engineer QA - Manufacturing

Ave Maria, FL

Full-time

Onsite

Senior Level

5+ years exp

Arthrex is a global medical device company focused on new product development and medical education in orthopedics. They are seeking a Senior Engineer QA for their manufacturing site in Ave Maria, FL, responsible for various Quality Assurance functions in the development of medical devices, ensuring compliance with design specifications and leading quality initiatives.

Health CareMedical Device

Comp. & Benefits

H1B Sponsor Likely

Responsibilities

Participates in the development of medical devices and components from design initiation through design transfer and by representing Quality Assurance for manufacturability in all design and development project teams

Participates in all manufacturing activities to assure compliance of design specifications

Leads development of quality plans of new product introductions based on designspecificatons, PFMEA, and control plans

Works with design team and assist/provide feedback on design specifications and improvements

Evaluates and develops effective and efficient methods of testing and inspection of products

Utilizes problem solving tools and techniques and apply risk based approach to problem solving

Determines necessity of testing and initiates testing by preparing test and inspection plans, and identifying and obtaining required test fixtures and test/inspection instrumentation

Initiates new projects and acts as the project leader for key initiatives, identifies best practices

Provides technical support on manufacturing technical issues

Performs quality trending and leads/supports process improvement initiatives

Approves manufacturing product and process changes and assures the change management is controlled, adequate, and documented

Ensures information and documentation is consistently accurate

Responsible for MRB activities for assigned products, timely resolution of nonconformities, issuing and/or monitoring corrective actions associated with nonconformance and deviations

Provides input and direction to other members of the quality assurance department to assist them in their assignments and provide them with learning experience

Supports manufacturing suppliers with assistance in on-site resolution of quality and process related issues andcorrective and preventive actions

May supervise other engineers, technicians, and support personnel

Qualification

Quality AssuranceManufacturing processesRisk assessmentsProcess improvementStatistical Process ControlProject managementTechnical supportMathematical skillsCommunicationProblem solving

Required

Bachelor's degree in Engineering required

5 years experience in a Quality Control or Quality Assurance position required, preferably in a medical device company

Working knowledge of risk assessments, design control requirements, PFMEAs, control plans, quality plans, testing and inspection equipment and techniques

Manufacturing process knowledge

Technical knowledge in development methodologies, design, project implementation, including, but not limited to GD&T, DOE, verification, and validation

SPC (Statistical Process Control) knowledge

Strong communication skills and ability to communicate effectively with technical and non-technical staff

Proficiency in the use of PC and programs, particularly Excel, Word (or equivalents if changed by the Company), QAD or similar inventory software

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

Ability to comprehend and apply mathematical principles to the degree required to perform the job based upon job requirements

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

Visual acuity necessary to do the job safely and effectively

Specific vision abilities required by this job include close vision

Preferred

Project management skills preferred

Recognized process improvement (i.e.: Lean, Six Sigma) and problem solving (i.e.: RCA, DMAIC, 5 Whys) training preferred

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)

Company

Arthrex

Glassdoor4.0

Arthrex is a global medical device company and leader in new product development and medical education in orthopedics.

Founded in 1981

Naples, Florida, USA

10001+ employees

https://www.arthrex.com/

H1B Sponsorship

Arthrex has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)

Distribution of Different Job Fields Receiving Sponsorship

Represents job field similar to this job

Trends of Total Sponsorships

2025 (30)

2024 (22)

2023 (13)

2022 (13)

2021 (9)

2020 (12)