Quality engineer customer - systems - validation
Description
At American Packaging Corporation (APC), you’ll find the packaging career you’ve been looking for. With competitive salaries, excellent benefits, 401(k) plans and tuition reimbursement programs, we nurture our employees while advancing and promoting diversity and inclusion. As the leading flexible packaging converter in North America for over a century, APC’s longstanding success is fueled from the inside out. We’re constantly seeking to improve our internal operations and were named a “Best of the Best” in the Best workplaces in the America’s awards for 12 years in a row. It’s how and why we engage the best and brightest talent to continue propelling our shared success into the future. LOCATION: Rochester, NY SUMMARY: Customer- Champion of customer advocacy, responsible for transforming the Voice of the Customer into actionable opportunities and driving customer satisfaction through data-driven analysis for prioritization of corrective measures and improvement opportunities. Systems- Responsible for championing the Integrated Business Management System (IBMS), maintain certification to ISO9001, 14001, FSSC and other standards as required, provide training, and writing procedures and processes to support the IBMS development. Lead and undertake audits across all areas of the business as well as across the supply chain. Maintain statistical tools for continuous quality and profit improvement projects. Lead and drive improvement actions from audits, customer complaints, and continuous improvement. Be the change agent for quality related projects. Validation- Apply project management and technical expertise to successfully deliver Validation program goals and outcomes while interacting with customers and meeting their expectations. ESSENTIAL DUTIES AND RESPONSIBILITIES: Customer- Leadership and management of customer complaint program including associated return and credit authorizations, leadership of team to identify root causes, implementing corrective actions to prevent recurrence and mitigate future quality risks, and timely communication back to customers.
- Monitoring and reporting of complaint and quality data and trends for area dashboards, operations review, and systems management review.
- Execution of formal weekly/monthly/annual Complaint Performance Reviews and reporting of complaint status to management team.
- Provide backup for Quality Supervisors and Quality technicians.
- Travel as required to work with customer, understand their concerns, and resolve issues.
- Drive continuous improvement opportunities utilizing lean six sigma and the seven basic quality tools, to benefit the success of APC, including profit improvement plans, long and short-term strategic objective, helping establish problem solving teams and methods, and recommend capital projects that improve Safety, Productivity, and Quality.
- Write and improve manuals, standards, and procedures as needed.
- Use of statistical software and techniques for analysis of data including Process Capability (Cpk, Ppk), Statistical Process Control (SPC), and Design of Experiments (DOE)
- Other duties as assigned.
- Oversee effective implementation of the IBMS including applicable certifications.
- Maintain manuals and procedures and determine future procedural needs of the business.
- Organize and manage the internal audit system and the corrective action system.
- Host external audits, conduct internal audits and assist in training of other auditors.
- Collect and analyze quality data and report on Key Performance Indicators (KPIs) to drive improvement.
- Project leader for quality and continuous improvement activities and promote the use of improvement tools such as Six-Sigma, Error Proofing, and Measurement System Analysis.
- Statical analysis of data using Excel, JMP, Minitab or other statistical software tools.
- Recommend Capital projects that improve Safety, Productivity, and Quality within the operation.
- Be the next level for complaint resolution with customers beyond the administration of the complaint. Duties would include identifying root cause, implementing corrective actions, and driving projects to proactively mitigate future quality risks.
- Other duties as assigned.
- Manage the scope, schedule, and reporting of Validation program activities for individual products and/or customers; ensure status, risks, and open issues are tracked and that all stakeholders (Management, internal/external clients, Business Managers/Project Managers, and regulatory agencies) are informed in a timely manner.
- Write and execute IQ/OQ/PQ validation protocols and management of associated deviation process.
- Management and leadership of change control process, calibration process, and gage R&R process.
- Provide hands on support to the manufacturing areas as required to assist in problem solving and long-term changes that provide product/process improvements in relation to process failures. Collect and analyze data to make data driven recommendations/decisions.
- Participate in process failure investigations.
- Maintain up to date knowledge of validation requirements, practices, and procedures and instruct other members of the site participating in validation studies.
- Support risk analysis activities, including design and process FMEA.
- Facilitate team meetings as needed on in-depth process and product analysis, risk assessments, decision-making, and other evaluations related to the Validation program.
- Assist in internal and 3rd party audits.
- Provide backup for Quality Supervisors and Quality technicians.
- Drive continuous improvement opportunities utilizing lean six sigma and the seven basic quality tools, to benefit the success of APC, including profit improvement plans, long and short-term strategic objective, helping establish problem solving teams and methods, and recommend capital projects that improve Safety, Productivity, and Quality.
- Write and improve manuals, standards, and procedures as needed.
- Use of statistical software and techniques for analysis of data including Process Capability (Cpk, Ppk), Statistical Process Control (SPC), and Design of Experiments (DOE)
- Other duties as assigned.
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