QUALITY ASSURANCE ENGINEER- Medical Tapes

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Overview

Nautic Partners, LLC completed its acquisition of the Specialty Tapes business from Berry Global Group, Inc., rebranding the company as Vybond™. As a standalone business, Vybond is poised to strengthen its leadership in pressure-sensitive adhesive tapes, delivering innovative solutions to industrial and specialty markets worldwide. Headquartered in Franklin, KY, with facilities in Riverhead, NY, and Bristol, RI, Vybond Group, Inc. manufactures specialty foil, film, and duct tapes and adhesives. With over 1,500 specialty SKUs spanning 500 product families, Vybond serves 1,500 customers across the HVAC, building and construction, industrial, retail, medical, aerospace, automotive, and other specialty industries.

Responsibilities

RESPONSIBILITIES:

• Assist in maintaining Berry QMS in compliance with ISO 9001-2015, FDA QSR, ISO 13485, , and ISO 17025 requirements
• Create, revise, and review procedures (SOP), work instructions (WI) and Form Control Documents (FCD) related to Quality process to maintain compliance with ISO and FDA requirements.
• Champion use of risk analysis and reduction tools (FMEA, etc).
• Conduct internal audits, as a member of the internal audit team (ISO Requirement).
• Prepare and analyze SPC charts for product and process parameters for current and new medical products.
• Generate and submit PPAP, IQ/OQ/PQ or other customer requirements for robust management of change / new product or process introduction.
• Review and validate internal management of change data before new or changed product / process commercialization.
• Maintain Test Method Validation (TMV) process to ensure new test methods are repeatable and predictable.
• Provide analysis of data on Gage R&R and inter laboratory comparison experiments in accordance with requirements of ISO 17025 and customer requirements.
• Establish and maintain robust Device Medical Records (DMR) that meet all FDA requirements.
• Establish and maintain Device History Records (DHR) that meet all FDA requirements.
• Maintain customer feedback and complaint records per ISO9001, ISO13485, and FDA requirements.
• Provide information on Return Material Authorization (RMA) from customer complaints
• Lead weekly customer complaints meeting (TICS) and take a follow-up with assigned members on progress of the customer complaint program.
• Follow and rigorously enforce all safety rules and regulations.
• Recall Coordinator - Lead mock and official recall activities.
• Perform additional duties as needed.
  
  

Personnel

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• In collaboration with department leadership develops and reviews role appropriate training curriculum.
• Partners with cross functional department supervisors to administer competency evaluations and periodic reviews and or renewals
• Ensures training compliance for new or revised SOPs as requried.
• Ensure the department is operating in accordance with company principle/policies/guidelines
  
  

QUALITY

• Establish, promote and maintain a culture of KAIZEN continuous improvement, quality, high performance and process excellence.
• Ensures total compliance to process, product specifications, labeling, quality audits, and cGMP. Co responsible for the department’s compliance with the company’s ISO9000 certification and FDA requirements.
• Actively participate in root cause analysis sessions, Kaizen events and other improvement strategies.
  
  

Qualifications

QUALIFICATIONS:

• A Bachelor’s Degree in applied mathematics (with statistics), Engineering, or similar field.
• 2-5 years of experience in quality engineering within the medical device industry or 10 years in lieu of degree.
• Proficiency in Minitab, Excel, Access, PowerPoint and Word programs.
• Experience with FDA QSR, ISO 13485, and ISO 14971 standards.
• Direct experience with Test Method Validation (TMV), Corrective and Preventive Actions (CAPA), and managing non-conformances.
• Leadership and communication skills
  
  

Compensation: $80,000 to $95,000 Annually

Relocation will not be provided to candidates at this time.

We do not offer future or current sponsorship at this time

We are an Equal Opportunity Employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity, status as a veteran, and basis of disability or any other federal, state or local protected class. (https://careers-berryglobal.icims.com/jobs/27409/quality-assurance-engineer--medical-tapes/job?mode=apply&apply=yes&in_iframe=1&hashed=-1834445335)

Location US-NY-RIVERHEAD

Job ID 2025-27409

Position Type Regular Full-Time

Category Quality Assurance & ISO Management

Location : Address 1852 OLD COUNTRY ROAD