Quality Engineer: Validation

Overview 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: THIS POSITION WILL PRIMARILY FOCUS ON THE VALIDATION TASKS OF THE JOB DESCRIPTION Apply project management and technical expertise to successfully deliver Validation program goals and outcomes while interacting with customers and meeting their expectations. Responsibilities ESSENTIAL DUTIES AND RESPONSIBILITIES: Validation 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 manage the associated deviation process. Management and leadership of the change control, calibration, and gage R&R processes. Provide hands-on support to manufacturing areas as required to assist with problem-solving and long-term changes that lead to product/process improvements related 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 site members 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 objectives, helping establish problem-solving teams and methods, and recommending 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. Qualifications REQUIREMENTS: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below represent the knowledge, skills, and/or abilities required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. EDUCATION and/or EXPERIENCE Bachelor's degree in science, mathematics, or engineering from a four-year college or university, and two years related experience and/or training; or equivalent combination of education and experience. ASQ certification is preferred. LANGUAGE SKILLS Ability to read, analyze, and interpret common scientific and technical journals, financial reports, and legal documents. Ability to respond to common inquiries or complaints from customers, regulatory agencies, or members of the business community. Ability to write speeches and articles for publication that conform to prescribed style and format. Ability to effectively present information to top management, public groups, and/or boards of directors. MATHEMATICAL SKILLS Ability to apply advanced mathematical concepts. Ability to utilize descriptive statistics (average, variation, standard deviation) to analyze data and support process control and capability analysis. Ability to create and interpret control charts, histograms, Pareto charts, and scatter diagrams. Ability to develop statistically appropriate sampling plans. Ability to use and learn statistical analysis software. REASONING ABILITY Ability to define problems, collect data, establish facts, and draw valid conclusions. Ability to interpret a wide variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables. PHYSICAL DEMANDS The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to use hands to finger, handle, or feel, and talk or hear. The employee is frequently required to sit and reach with hands and arms. The employee is occasionally required to stand, walk, climb, or balance, and to stoop, kneel, crouch, or crawl. Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception, and the ability to adjust focus. This position may require manual lifting not to exceed 50 lbs – reference your department-specific JHA (job hazard analysis) for departmental lifting restrictions. WORK ENVIRONMENT The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. American Packaging Corporation is committed to equal opportunity for all, without regard to race, religion, color, national origin, citizenship, sex, sexual orientation, gender identity, age, veteran status, disability, genetic information, or any other protected characteristic. American Packaging Corporation will make reasonable accommodations for known physical or mental limitations of otherwise qualified employees and applicants with disabilities unless the accommodation would impose an undue hardship on the operation of our business. EOE/AA Disability/Veteran. If you are interested in applying for an employment opportunity and need special assistance or an accommodation to apply for a posted position, please contact our Human Resources department at View email address on click.appcast.io. #J-18808-Ljbffr