Apply on Employer Site

Arthrex · 1 day ago

QA Specialist II - Sterilization

Ave Maria, FL

Full-time

Onsite

Entry, Mid Level

2+ years exp

Arthrex, Inc. is a global medical device company and a leader in new product development and medical education in orthopedics. They are seeking a QA Specialist II for their manufacturing site in Ave Maria, FL, responsible for maintaining the quality assurance program for the Sterilization Facility and ensuring compliance with quality systems requirements.

Health CareMedical Device

Comp. & Benefits

H1B Sponsor Likely

Responsibilities

Ensure proper and timely accurate completion of sterile load files of AMI products

Maintain the Sterile Release program for loads produced by AMI and ensure timely and safe product release to meet customer requests

Report and act by opening, disposition, evaluating, and closing on Non Conformances observed during sterilization processes for AMI to provide a resolution for the disposition of affected loads

Support the AMI Sterilization Facility Personnel to investigate Non Conformances related to sterilization processes in order to determine the root cause and prevent re-occurring issues

Support the AMI Sterilization Facility program to identify and encourage process improvement

Maintain procedures related to the Quality Assurance – Sterilization department activities and review procedures / records related to the AMI Sterilization Facility processes

Function as lead auditor and/or subject matter expert for quality management system audits of Arthrex’s sterilization service providers in accordance with applicable standards, e.g., ISO 13485, ISO 11135, ISO 11137 parts 1 and 2, and international regulatory directives

Generate and execute protocols for sterilization processes (i.e. EO, Gamma, X-Ray etc.) and equipment validation and re-validations, along with reports and conclusions

Manage all activities related to sterilization validations and/or testing, and directly interact with external and corporate laboratories, and sterilizers personnel to accomplish the assigned tasks

Assess devices for compatibility to proper sterilization modalities, e.g., radiation and ethylene oxide, by validating and/or adopting Arthrex manufactured products to established or new families using microbiological and sterilization theory and practice according to applicable ISO requirements

Effectively work within a cross functional team environment as both a champion and team member

Support Arthrex business and expansion goals

Must be able to travel domestically and internationally up to 10% of the time

Qualification

FDA guidelinesISO 13485Sterilization validationCAPA processesSterilization modalitiesProject managementReport writingRisk managementManufacturing process knowledgeMicrosoft Office SuiteSAP experienceCommunication skillsTeam collaboration

Required

BS in STEM discipline

2+ years relevant experience

Knowledgeable of FDA and ISO guidelines for the sterilization modalities of medical devices required

Working knowledge of sterilization test systems requirements

Hands on experience managing sterilization product assessments and validations

Test protocol and report writing experience

Knowledge of ISO 13485 guidelines and principles of quality requirements

Experience with CAPA processes and non-conformance investigation techniques to determine root-cause

Experience in project management, risk management (such as FMEA, FTA, FMECA) tools are highly desirable

Experience in working in Medical Device industry, CAPA, Complaint Management, and Nonconformance Reporting required

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)

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

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

Preferred

Manufacturing process knowledge preferred

Project management and communication skills training preferred

SAP and / or Pilgrim Quality Data experience desirable

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)