Quality Engineer (Medical Device)

Position Purpose:

Uses engineering principles, team facilitation skills, and statistical process control tools to measure and improve key processes integral to the manufacturing of printed and unprinted laminated packaging materials for the pharmaceutical and medical packaging industry. Identifies key processes and develops relevant metrics to ensure process variables are quantified and within control. Identifies and conducts projects and facilitates cross-functional improvement teams to improve manufacturing efficiency and reduce variability.

Essential Functions:

• Manage the customer complaint system with the goals of prevention of future occurrences and complaint avoidance via the Root Cause and Correct Action (RCCA) process.
• Ensure all product shipped meets customer requirements in accordance with Customer Specifications.
• Work directly with machine operators to identify needs and develop solutions; work with Maintenance on equipment modifications and preventative /predictive maintenance to ensure reliability.
• Identify, propose and execute projects to improve customer satisfaction, through performance and product reliability. Develops / improves product reliability, performance consistency and cost effectiveness.
• Review Material specifications to ensure the necessary criteria and provisions are included to meet the quality and continuous improvement requirements.
• Develop thorough knowledge of all manufacturing processes and equipment; monitor and assess all equipment performance.
• Lead or participate in internal and external quality audits.
• Drive continuous improvement activities and stays current with the industry best practices.
• Contribute to maintaining strong positive working relationships with customers and suppliers.
• Statistically evaluate process parameters and assess impacts of material changes to efficiency and process integrity, which will result in scrap rate reductions and increase yields.
• Develop strategies for quality/process improvements and evaluate impact of such changes; actively participate in and/or drive root cause analysis and process improvement efforts.
• Evaluate and modify risk assessment tools, such as FMEA/control plans, based on actual performance.
• Compile, write and/or review validation and verification protocol activities with accuracy.
• Maintain and protect proprietary information as related to Company and its customers.
• Compile, write and deliver training to associates on new/revised quality standards and activities.

Non-Essential Functions:

• Perform other duties as assigned.

Essential Requirements:

• Must be able to support manufacturing operations active 24/7.
• Occasional travel to customers/suppliers may be required.

Job Qualifications, Knowledge, and/or Experience:

• Bachelor’s degree in Engineering or related field with 7-10 years’ experience.
• Prefer experience in web handling or film converting industry (printing, coating, extrusion and lamination processes).
• Strong communication and computer skills to work with Quality Assurance applications, word processing, spreadsheets and databases, etc.
• Demonstrated experience in statistical analysis, Six Sigma, Lean Manufacturing, or formal continuous improvement programs.
• Has experience with or capable of learning and complying with GMP regulations, ISO 13485, or food safety compliance.

We offer a full complement of valuable Health, Wellness, and Welfare benefits which include:

• PTO & 8 Company Holidays
• Medical, Dental, and Vision.
• Life and Disability.
• 401(k) and Match.
• Wellness Program including EAP.
• Pay for Performance philosophy.
• Medical benefits are effective on the first day of the month after being hired