Senior Manufacturing Quality Engineer

Senior Manufacturing Quality Engineer

Trans Medics, Inc. is seeking a Senior Manufacturing Quality Engineer who will develop, implement, and manage quality systems for manufacturing, focusing on process improvement, defect reduction, and compliance. The role involves root cause analysis (CAPA), audits, statistical process control (SPC), FMEAs, training junior staff, and ensuring adherence to ISO/regulatory standards.

• Utilize statistical data analysis for trending and investigation purposes.
• Communicate ideas and information clearly, effectively, and concisely.
• Provide quality engineering support in manufacturing of medical devices & hardware.
• Ensure compliance of manufacturing processes and areas to all applicable quality system regulations.
• Lead Nonconformance (NCMR) process, including inspection methods, containment, correction, closure, and CAPAs, and drive continuous improvements through analysis of trend data.
• Monitor and analyze production information to support risk management and provide direction for corrective and preventive actions and/or process improvement activities.
• Partner with manufacturing engineering to ensure necessary process controls and validations are in place and best practices are followed (GMP).
• Partner with Manufacturing Engineering to implement and maintain electronic manufacturing and inspection work instructions within a Manufacturing Execution System (MES).
• Oversee inspection & testing of raw materials, components & finished products to ensure compliance with specifications & quality standards; establish and maintain quality control procedures, including inspection methods and test protocols.
• Support internal and external auditing requirements in manufacturing to ensure compliance with quality system requirements.
• Support other Quality Engineering functions as required (supplier quality, service, design QA).
• Perform other Trans Medics tasks and duties as required.

This position does not have management responsibilities.

• Office and clean room environments.
• Ability to lift up to 25 pounds.

• Bachelor's Degree in Mechanical, Electrical, or Biomedical Engineering or other scientific or related discipline.
• Minimum of 8 years’ experience in a Manufacturing Quality and/or Manufacturing Engineering role.
• Experience with work instruction development and maintenance within an MES environment.

• Working knowledge of Medical Device Regulations: FDA 21 CFR 820, ISO 14971 & 13485 and other applicable regulations and industry standards pertaining to Medical Devices.
• Experience with manufacturing of complex medical device products; experience with medical capital equipment and electromechanical devices preferred.
• Experience with formal problem-solving methodologies and deductive skills, root cause analysis & CAPA.
• Experience with handling non-conforming material and assemblies.
• Practical knowledge and experience using Minitab or other statistical analysis tools; understanding & application of Gage R&R and Measurement system analysis desired.
• Experience with process validation.
• Experience with non-product software implementation and validation.
• Familiarity with Manufacturing Execution Systems (MES) software.
• Experience presenting data and information to management, including senior and/or executive management.

• Medical with Health Reimbursement Account through Blue Cross/Blue Shield of MA.
• Dental.
• Vision.
• Healthcare Flexible Spending Account.
• Dependent Care Flexible Spending Account.
• Short Term Disability.
• Long Term Disability.
• 401K Plan.
• Pet insurance.
• Employee Stock Purchase Plan.

The expected base salary range for this role is $118,600 - $148,000. This role may also be eligible for bonuses, equity, and a comprehensive benefits package. We comply with all U.S. pay transparency laws and do not request or consider salary history.

Trans Medics is an equal opportunity employer and does not discriminate on the basis of race, color, religion, sex, national origin, marital status, age, disability or protected veteran status, or any other characteristic protected by law. We are committed to creating an inclusive environment for all employees.

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