Sr Quality Engineer

Katalyst CRO; Danvers (MA); On-site; USD 85,000 - 110,000; Full time

Job summary

Katalyst CRO is seeking a Senior Quality Engineer in Danvers, Massachusetts, who will provide comprehensive quality support for commercial medical devices. The ideal candidate must have a Bachelor's degree in Engineering, Sciences, or a related field with 5-7 years of relevant experience, especially in medical device design and development. Key responsibilities include ensuring compliance with quality standards, performing statistical analysis, and collaborating with engineering functions. Preferred qualifications include Six Sigma certification and familiarity with Quality System Regulations.

Qualifications

• 5-7 years of experience in Engineering and/or Quality or 2 years with Advanced Degree.
• Experience in medical device design and development.
• Hands-on in upstream product development and downstream operations quality.

Responsibilities

• Provide quality engineering support for medical device products.
• Develop and maintain quality standards for processing materials.
• Collaborate with engineering and manufacturing to ensure quality standards.

Skills

Quality Engineering principles

Test method validation

Statistical analysis

Risk management

Quality tools including FMEA

Document control

Six Sigma

Education

Bachelor's Degree in Engineering, Science or technical field

Advanced Degree in Engineering, Science or technical field

Tools

SAP QM

SPC software

Job description

Overview

Senior Quality Engineer responsible for providing comprehensive manufacturing quality support for commercial medical devices in the area of component manufacturing. This includes activities related to test method validation, process validation, inspection improvements, and process/quality change initiatives. The role involves applying quality engineering principles across design, manufacturing, and product lifecycles while ensuring compliance with global regulatory standards. Provide Quality Engineering support for commercial medical device products.

Roles & Responsibilities

• Provide Quality Engineering support for commercial medical device products.
• Develop, modify, apply and maintain quality standards and protocols for processing materials into partially finished or finished materials products.
• Collaborate with engineering and manufacturing functions to ensure quality standards are in place.
• Devise and implement methods and procedures for inspecting, testing and evaluating the precision and accuracy of products and production equipment.
• Design or specify inspection and testing mechanisms and equipment; conduct quality assurance tests; and perform statistical analysis to assess cost and responsibility for products or materials that do not meet required standards and specifications.
• Specialize in areas such as design, incoming material, production control, product evaluation and reliability, inventory control and/or research and development as they apply to product or process quality.
• Apply knowledge of design control principles, statistics, process and systems validation, and quality engineering techniques to positively influence projects and manufacturing.
• Ensure changes to products are developed and manufactured in accordance with applicable industry standards, regulatory requirements and customer requirements.
• Present quality aspects during new product introduction projects and provide quality support for documentation changes, change control, process transfer and equipment installation.
• Present technical data to groups within and outside the organization.
• Utilize quality tools including risk analysis (FMEA), statistical techniques including Six Sigma and DOE (Design of Experiments), root cause analysis, and reading and correcting drawings.

Education & Experience

• Bachelor's Degree in Engineering, Science or technical field AND 5-7 years of work experience in Engineering and/or Quality OR Advanced Degree in Engineering, Science or technical field AND 2 years of work experience in Engineering and/or Quality.
• Medical Device Design & Development experience.
• Risk Management experience including dFMEA, pFMEA, and statistical analysis.
• Technical writing experience including IQs, PQs, TMVs.
• Hands-on experience in upstream new product development and downstream manufacturing transfer and operations quality.
• Working knowledge of Quality System Regulation (QSR 21 CFR 820), Canadian Medical Device Regulation (CMDR), EU Medical Device Directive (EU MDD 93/42 EEC), JPAL, and ISO 13485:2016.
• Demonstrated working knowledge of process validation, statistical methods, and risk management.
• Green Belt Six Sigma/DRM Training/Certification preferred.
• ASQ-CQE, CQA, CBA or equivalent certifications preferred.
• SAP QM or SPC software experience preferred.