Quality Engineer Medical Device Jobs in Rochester, NY

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: Chili, 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.

Systems

• 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.

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 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.

Requirements

QUALIFICATION REQUIREMENTS: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

EDUCATION and/or EXPERIENCE

Systems - Bachelor's degree (B. A.) from four-year college or university; and two years related experience and/or training; or equivalent combination of education and experience. ASQ certification is a plus.

Customer & Validation - Bachelor's degree in science, mathematics, or engineering from four-year college or university, and two years related experience and/or training; or equivalent combination of education and experience. ASQ certification is a 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

Systems - Ability to apply advanced mathematical concepts such as exponents, logarithms, quadratic equations, and permutations. Ability to apply mathematical operations to such tasks as frequency distribution, determination of test reliability and validity, analysis of variance, correlation techniques, sampling theory, and factor analysis. Demonstrated use of Minitab or JMP is a preferred skill.

Customer & Validation - 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 an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables.

PHYSICAL DEMANDS

Systems - 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 sit. The employee frequently is required to talk or hear. The employee is occasionally required to walk. 

Customer & Validation - 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 frequently required to stand, use hands to finger, handle or feel objects, tools or controls. The employee is occasionally required to sit, reach with hands and arms, stand, walk, stoop, kneel, crouch or crawl and climb or balance. The employee is regularly required to hear. This position may require manual lifting not to exceed 50 lbs - reference your department-specific JHA (job hazard analysis) for departmental lifting restrictions. Specific vision abilities required by this job include close vision, distance vision, color vision, and the ability to adjust focus. Employee must also be able to taste/smell.

WORK ENVIRONMENT

Systems- The noise level in the work environment is usually moderate. While performing the duties of this job, the employee is regularly required to sit. The employee frequently is required to talk or hear. The employee is occasionally required to walk. 

Customer & Validation - The noise level in the work environment is usually moderate.

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:

talentacquisition@americanpackaging.com.