QUALITY ASSURANCE ENGINEER- Medical Products

Overview

About BerryAt Berry Global Group, Inc. (NYSE: BERY), we create innovative packaging and engineered products that we believe make life better for people and the planet. We do this every day by leveraging our unmatched global capabilities, sustainability leadership, and deep innovation expertise to serve customers of all sizes around the world. Harnessing the strength in our diversity and industry-leading talent of over 40,000 global employees across more than 250 locations, we partner with customers to develop, design, and manufacture innovative products with an eye toward the circular economy. The challenges we solve and the innovations we pioneer benefit our customers at every stage of their journey. For more information, visit our website, or connect with us on LinkedIn or Twitter.

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

Salary : $80,000 - $95,000