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Coghlin Companies, Inc. · 5 days ago

CT -4870 Quality Engineer II

Westborough, Massachusetts, United States

Full-time

Onsite

Mid, Senior Level

$84K/yr - $110K/yr

5+ years exp

Coghlin Companies, Inc. is seeking a Quality Engineer II to join their team. This role involves leading compliance adherence, training personnel on quality standards, and ensuring outgoing products meet compliance requirements.

ElectronicsIndustrialManufacturing

Responsibilities

Lead by example and promote the criticality of strict compliance adherence at Columbia Tech

Lead in the training of personnel on workmanship and quality standards, where applicable

As part of the Columbia Tech team, assure all outgoing product is manufactured in a compliant manner

Support process qualification/validation and new product introduction processes, where applicable

Development and execution of Quality Plans for customer accounts

Review device history records for quality approval, where applicable

Support and execute Redline and Engineering Change Notifications (ECN’s) processing. Collaborate with Project Managers (PM’s) to analyze customer ECN’s and ensure effective implementation to the production floor through proper use of the Engineering Change Order (ECO) process, including reviewing and communicating impacts of any changes (e.g., financial, inventory, WIP, open supplier orders, etc.), as it pertains to Quality

Suggest improvements to ECN/ECO process that lead to improved efficiency, accuracy, and quality

Drive improvement of Columbia Tech Quality through analyzing non-conformances (NC’s) and performing root cause analysis of discrepancies. Propose, review and implement approved corrective and preventive actions

Collaborate with all internal groups and customers to help determine root cause of customer issues, Complaints, and CAPAs using various techniques including but not limited to Reenactment, PFMEA, Control Plans, Five Whys, Ishikawa (fishbone) Diagrams, Pareto Analysis, etc

Support Supplier Quality Engineering with non-conforming material issues resolution with suppliers, where applicable

Collaborate with cross-functional team to help determine root cause of customer issues

Support the Quality Control inspection process, where applicable. Develop specific Quality Assurance Forms (QAF’s), when required. Provide Training, as needed

Support the development of quality Receiving Incoming Inspection (RII) plans, as needed

Assist in regulatory audit for customer accounts

Continually build strong rapport with customers through data collection, metrics generation and presentations

Promptly respond to manufacturing floor quality issues, taking appropriate action within the Columbia Tech Quality System

Work with Manufacturing Engineers, assembly, production and test to identify trends and propose and implement corrective actions

Collaborate with Engineering to develop optimal work order routings, where applicable

Collaborate with Supply Chain, PM’s and Operations on managing the Material Review Board (MRB) process

Support improvement projects, where applicable

Qualification

ISO 9001Electro-mechanical orientationCertified Quality EngineerMS WordMS ExcelMS VisioCustomer serviceProblem solvingTeamworkCommunication skills

Required

Positive attitude, self-motivator, and tenacious follow up required

Superior customer service attitude

Excellent teamwork, communication, and interpersonal skills

Bachelor's degree, preferably in a science or engineering discipline. Significant and applicable professional experience may be considered in lieu of certain educational requirements

Strong electro-mechanical orientation

Proven problem solver

Preferred

Minimum of 5 years professional experience in electro-mechanical manufacturing field preferred

Experience in ISO 9001 requirements is preferred

Knowledge of IPC 610 and 620 standards beneficial

Advanced Level Skills in MS Word and Excel such as keyboard short cuts, creating macros and forms, table techniques, working with images, text and pivot tables

Advanced Level Skills in MS Visio such as creating Visio diagrams, creating custom styles and templates, cross functional flow charts, linking drawings to other MS applications, working with data, custom reports, and exporting is valuable

Certified Quality Engineer (CQE) preferred

Company

Coghlin Companies, Inc.

Coghlin Companies provides world-class Time to Market Services™ (TTMS) with a specific focus on the successful commercialization of industrial capital equipment and FDA-compliant medical devices through our wholly-owned subsidiaries, Columbia Tech and Cogmedix.

Founded in 1885

Westborough, Massachusetts, USA

501-1000 employees