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:

• 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