At Beacon MedTech Solutions quality is more than inspection and documentation — it is the foundation of everything we build. We are looking for a Quality Engineer who wants to play a critical role in delivering precision-engineered products used in demanding medical and commercial applications.
This role is ideal for someone who thrives in a hands-on manufacturing environment and enjoys partnering with Engineering, Operations, and customers to solve complex problems, strengthen processes, and ensure our products meet the highest standards of performance, reliability, and regulatory compliance.
If you are someone who enjoys improving systems, driving root cause solutions, and building a culture where quality is owned by everyone — we want to talk with you.
Company Description
Beacon MedTech Solutions is a trusted contract manufacturing partner known for solving complex manufacturing challenges, from design for manufacturability (DFM) to assembly. Specializing in Medical, Bio-Pharma, and Life Sciences, as well as Aerospace and Technology applications, our state-of-the-art 110,000-square-foot facility is ISO 13485 and ISO 9001 certified and ITAR-registered. We offer a wide range of advanced manufacturing solutions, including precision molding, cleanroom injection molding, and complex assembly services. With a focus on innovation and customization, we combine expertise across engineering, manufacturing, and quality to exceed stringent client expectations. Beacon MedTech Solutions is part of Beacon Manufacturing Group, committed to driving growth and excellence for its partners.
Role Description
This is a full-time, on-site Quality Engineer role based in Leominster, MA. The Quality Engineer will be responsible for maintaining and ensuring compliance with quality requirements to meet customer expectations through internal and external product quality investigations, corrective actions, and communications. Drives the development and training of inspection methods and execution with the quality control team. Supports validation projects through statistical evaluations and interfaces with internal and external customers.
Essential Functions/Responsibilities:
- Drives the containment, investigation, and resolution of internal nonconformances, customer complaints and/or nonconformances as needed.
- Reviews, develops, and executes engineering change orders for internal or external requirements/specification changes.
- Supports the Corrective and Preventive Action process in response to quality excursions and ensures CAPAs are effective in addressing root causes, verification, and validation of plans for complete closure.
- Develops, documents and implements sampling plans/techniques in support of product inspections per applicable industry standard and/or customer specifications.
- Utilize Failure Mode Effects Analysis (FMEA) to identify risks within process/product inputs/design characteristics and implement control plans to mitigate identified risks.
- Provides support and feedback to the QC Inspection team by mentoring, coaching, training in measurement method interpretation, method, and execution.
- Works with Program Managers to support validation activities (IQ, OQ, PQ), including but not limited to training, measurement, data analysis, and reporting.
- Coordinates, plans, and executes Measurement System Analyses (MSA) (e.g. gauge R&R measurement capability studies) in accordance with established standards.
- Utilizes Minitab and other qualitative and statistical methods and tools to collect, summarize, analyze, interpret, and communicate process capability and performance, including the use of key statistical process control (SPC) tools.
- Communicate effectively and work directly with the Tooling and Manufacturing functions to make sure adequate systems and inspection methods and tools are used throughout the plant for molding or assembling products.
- Communicate effectively with customers and serve as the Quality Contact for Customers to address product quality concerns and improvement opportunities.
- Utilize lean six sigma techniques and methodology to drive waste out of the processes in efforts to reduce lead times, process cycle time, TAKT time (touch labor) while maintaining quality performance.
- Identify and drive continuous improvement activities in support of product Quality and quality management system.
- Adheres to, and ensures compliance with Quality System SOPs, product SOP’s/IMS’s, work instructions, and specifications.
- Participates in internal and external audits, as directed.
Qualifications
- Proficient with MS Word and Excel.
- Ability to communicate with others in an empathetic and professional manner at all levels in the organization across all departments, in alignment with company policies, procedures, and guidelines.
- Able to read, analyze and interpret technical specifications and drawings.
- Effective planning and organizational skills.
- Use of Minitab Software to conduct Measurement System Analysis via Gauge R&R studies, capability studies etc.
- Experience in the use of measuring instruments and gauges (calipers, micrometers, height gages, etc.), measuring devices of a specialized nature (CMM, Micro-Vu), and surface plate layout ability preferred.
- Ability to read and write in the English Language.
- Self-starter with strong work ethic
Education/Experience:
- Experience with SPC
- Experience with ISO 9001 & ISO 13485 Quality Management System requirements
- Previous experience in quality/engineering (preferably 3+ years)
