Quality Engineer

TekniPlex•Ashland, MA

48d•$80,000 - $85,000•Onsite

About The Position

TekniPlex is hiring a Quality Engineer for our Ashland, MA facility. This role provides site-level quality leadership for the Ashland, MA facility and is a key member of the plant leadership team. The role is responsible for maintaining and continuously improving product, process, and Quality Management System performance; ensuring compliance with customer, internal, ISO, GMP, and applicable regulatory requirements; and translating the Voice of the Customer into actionable manufacturing and supplier quality strategies. The Quality Engineer serves as the site Management Representative for Quality, holds Quality Authority for final disposition decisions for materials and product, and works directly with customers, auditors, suppliers, operations, engineering, product development, commercial teams, and Corporate Quality. The salary range for this role is $80,000 to $85,000 annually. Pay is based on experience.

Requirements

Bachelor’s degree in Engineering, Science, Quality, or a related technical field; or in lieu of, 6 years of quality experience in a manufacturing environment.
2 years of relevant Quality experience in a manufacturing environment; experience in operations, process engineering, and/or process control is preferred.
Hands-on experience implementing, maintaining, or supporting Quality Management Systems; experience with eQMS software such as Intelex is preferred.
Previous ISO and GMP experience required; strong working knowledge of ISO 13485:2016 is preferred, with ISO 9001 experience beneficial.
Knowledge of applicable FDA requirements (21 CFR); medical device and/or pharmaceutical packaging experience is preferred.
Flexible packaging / packaging industry experience and knowledge of packaging materials and processes are preferred.
Experience with customer complaints, CAPA, root-cause investigation, risk management/FMEA, validation, supplier quality, audits, change control, and document control.
Experience with Lean Manufacturing, Six Sigma, Kaizen, statistical methods, and other structured problem-solving tools.
Strong ability to compile, analyze, interpret, and communicate data; identify shifts and trends; determine root cause; and translate findings into effective remediation and improvement actions.
Strong computer skills, including Microsoft Excel, Word, and PowerPoint; experience with Minitab, ERP systems, planning software, and Quality System software.
Basic working knowledge of quality inspection equipment, instruments, measurement systems, and quality-control processes.
Demonstrated ability to partner with employees at all levels, lead teams and improvement efforts, and build accountability.
Strong verbal and written communication, customer-facing, interpersonal, negotiation, and conflict-resolution skills.
Strong attention to detail, self-motivation, sound judgment, and ability to work effectively both independently and in a team environment.
Ability to travel 25%.

Nice To Haves

experience in operations, process engineering, and/or process control is preferred.
experience with eQMS software such as Intelex is preferred.
strong working knowledge of ISO 13485:2016 is preferred, with ISO 9001 experience beneficial.
medical device and/or pharmaceutical packaging experience is preferred.
Flexible packaging / packaging industry experience and knowledge of packaging materials and processes are preferred.
Supervisory or leadership experience in a regulated manufacturing environment is preferred.
Preferred certifications include ASQ Certified Quality Engineer (CQE), Certified Quality Auditor (CQA), and/or Six Sigma Green Belt or Black Belt.

Responsibilities

Manage and continuously improve the site Quality Management System (QMS), including activities administered through Intelex/eQMS.
Own or oversee complaint management, nonconformances, CAPA/corrective actions, document control, change management, training management, supplier quality, audit management, calibration, and related quality-system processes.
Ensure products and processes meet internal specifications, customer requirements, quality agreements, ISO/GMP requirements, and applicable regulatory requirements.
Serve as the site ISO Management Representative and support compliance with ISO 13485, ISO 9001, GMP, and applicable FDA/21 CFR requirements.
Plan, host, and coordinate internal, customer, third-party, and annual ISO 13485 audits; work directly with customers and agencies during audits and post-audit activities.
Investigate audit findings and customer complaints; determine, implement, and verify effective corrective actions, with zero late responses to customer audit findings as the expectation.
Manage the customer complaint system, establish strong quality partnerships with customers, and drive timely complaint closure and reduction of complaint frequency and customer credit dollars.
Review customer quality agreements and customer specifications for the Ashland site and provide quality approval/sign-off as required.
Communicate directly with customers regarding complaints, investigations, change control, specifications, audit findings, and other quality matters.
Work closely with Operations, Customer Service/CAM, Account Managers, Sales, IT, Product Development, Engineering, Planning, and other functions to identify quality or compliance gaps and implement sustainable resolutions.
Manage validation activities with the appropriate cross-functional resources and support new product, process, and line launches.
Develop quality control plans for products as required and select, maintain, and improve inspection tools, quality equipment, instruments, and associated systems.
Provide oversight of supplier quality, including supplier approval, supplier complaints, performance issues, audits, and corrective actions.
Participate in cross-site internal audits and supplier audits; identify and share best practices and effective risk-elimination/mitigation approaches across Tekni-Plex sites.
Engage in risk assessment and risk management using tools such as FMEA; involve plant personnel in structured problem solving and risk-reduction activities.
Trend, track, analyze, and present quality performance data and KPIs to site management; complete monthly and annual KPI reporting and identify improvement priorities.
Drive reduction of internal quality issues and improvements in product repeatability, reliability, cost, and overall quality performance to meet or exceed established targets and site quality objectives.
Participate in the CAPA steering process and lead assigned CAPA, continuous improvement, and problem-solving activities using appropriate Quality, Lean, Six Sigma, statistical, and Kaizen tools.
Develop and implement quality training; support employee understanding of quality policies, the Quality System, GMP, and other applicable programs.
Provide supervisory oversight and day-to-day leadership of the site quality team, including the Quality Technician/direct report, performance management, coaching, accountability, and capability development.
Immediately escalate quality issues that present significant risk to the customer or business and exercise independent Quality Authority when required to protect product and customer requirements.
Participate in the facility Safety and Environmental programs; actively assess work for unsafe conditions or behaviors, reinforce safe work practices, support safety and housekeeping audits, and ensure applicable corporate initiatives are followed.
Maintain strong working relationships across all levels of the organization and with customers, suppliers, third-party contractors, and auditors while demonstrating ethical behavior, respect, integrity, and sound judgment.
Willingness and ability to travel up to 25% to support other Tekni-Plex facilities, including cross-site audits, quality system initiatives, continuous improvement activities, training, problem solving, and other operational or business needs as required.
Perform other duties and lead or participate in projects as assigned.