Quality Systems & Validation Specialist

Job Description

Job Description

EPTAM Precision Moldingis looking for aQuality Systems and Validation Engineerto join our team inLancaster, MA

EPTAM Precision Moldingis a trusted injection molding solutions partner. We are dedicated to supporting the complete product lifecycle in consumer products, healthcare, and defense industries. We're committed to helping our customers bring their products to market and streamline their supply chain.

EPTAM Solutions,Our parent company, with locations nationwide, is at the Heart of Manufacturing. We recognize our parts touch lives, and our teams assume this responsibility with vigor. Our minds never sleep. Join our incredible team at any one of our locations and reap the benefits of an employee-focused company. We excel at what we do for our customers, our employees, and the world.

JOB TITLE: Quality Systems and Validations Engineer

POSITION SUMMARY:The Quality Systems and Validations Engineer is primarily responsible for the following:

• Oversee effective implementation of the Quality Management System (QMS).
• Lead and undertake audits across all areas of the business.
• Provide training and champion the Quality Management System.
• Manage CAPA and Complaints systems and reporting performance.
• Working with Engineering planning and conducting or directing validation activities of manufacturing equipment, processes, and test methods.
• Validation activities include – but are not limited to – creating and executing validation plans, developing and conducting qualification protocols (e.g. IQ, OQ, PQ, etc.), training associates to an understanding of the significance of validation activities, training of associates required in the execution of qualification events, and analyzing & writing reports of qualification activity results.

ESSENTIAL FUNCTIONS: Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.

• Perform root cause analysis and resolve problems.
• Manage the CAPA and Customer Complaint Systems.
• Perform data analysis and trending and report such trends in management reviews.
• Oversee effective implementation of the Quality Management System, including any business accreditations.
• Maintain the Quality Management System and ensure contents are appropriate for business, in collaboration with the Quality Manager.
• Organize and manage the plant internal audit system and the corrective action reporting system.
• Conduct Quality Systems audits and assist in training/guidance to internal auditors.
• Assist/support Quality Manager during external Quality System audits.
• Provide training on Quality issues and awareness.
• Coordinate the review of Quality procedures associated with plant continuous improvement initiatives.
• Compile quality data and report on Key Performance Indicators (KPIs) to adhere to process and prevent occurrence of any non-conformity relating to product, process, or system.
• Represent Quality Engineering as part of site validation team new product introduction (NPI) and existing product transfer programs.
• Acquiring and understanding the company’s, customers’, and regulatory requirements for validation activities, and planning validation activities to maintain compliance to the same requirements.
• Receiving or acquiring product or process specifications, helping and/or creating validation plans for the manufacturing cycles to accomplish production of the same. A Quality Stems and Validation Engineer must be able to read technical drawings, standards, and articles.
• Acquiring equipment and process specifications and descriptions by coordinating with Manufacturing, Process, and Quality Engineers to create validation plans.
• Designing, developing and creating validation plans and accompanying qualification protocols, and negotiating the approval of qualification protocols prior to execution, including writing qualification reports and executive summaries. This includes validation plans for processing and test equipment (from commercially-available-off-the-shelf [COTS] to custom, in-house designed equipment), product specific manufacturing processes, test methods (i.e. analytical methods, mechanical properties testing, etc.), and…