Sr. Design Quality Assurance Engineer

POSITION SUMMARY: The Design Quality Assurance Engineer will develop and implement compliance strategies to support new product introductions & development within the areas of design, design transfer, manufacturing, and service. The Design Quality Assurance Engineer will ensure adherence to Quality Management Systems and regulatory requirements, use critical thinking and influencing skills to work cross-functionally to ensure robust quality decisions, and create a Quality culture by driving compliance activities.

ESSENTIAL FUNCTIONS:

Work with high-performing cross-functional teams to sustain the quality of medical device products

Responsible for Quality functions that impact patient care by ensuring the safety, quality, audit readiness, post-market performance, and compliance of products

Interface with cross-functional teams to complete sustaining projects, design control deliverables, and activities to ensure that medical device products continue to meet state-of-the-art regulatory standards and user needs

Effectively work with and influence cross-functional teams during the Design Change process to ensure proposed changes to products are systemically and thoroughly analyzed, assessed, controlled, and implemented appropriately (i.e., EN 13485 / CFR820)

Support Risk Management planning, updating, and maintenance of the product risk documentation (Hazard Analysis, Design FMEA, Task Analysis, and Fault Tree Analysis, etc.) in compliance with company and various industry standards

Support Usability Engineering and planning documentation

Support the sustaining effort for both product and packaging designs

Support manufacturing operation efforts and changes to ensure they meet or exceed internal and external requirements

Apply sound, systematic problem-solving methodologies (e.g., 5 Whys analysis, Is-Is Not analysis, DMAIC problem-solving methodologies) in identifying, prioritizing, communicating, and resolving quality issues

Support post-market activities ensuring products meet patient, customer, product performance, and quality system expectations through risk-based assessment of post-market signals

SKILLS & ABILITIES:

Computer Skills:

Advanced computer skills including MS Office applications (Word /Excel /Visio /PowerPoint / Project)

Minitab statistical analysis software is required.

Knowledge of statistical techniques and sampling for process validation and process monitoring is required.

Experience with Agile PLM or other documentation management systems.

Education: Bachelor’s Degree in Engineering or equivalent work experience.

Experience:

+7 years of direct Quality/Design Quality engineering experience in the medical device industry required.

Demonstrated use of quality tools/methodologies including SPC, DOE, GR&R, FMEA, CAPA, and process validation (IQ, OQ/PQ).

Must have a good understanding of FDA 21CFR820, ISO 13485, 14971, and 11607 standards.

Strong engineering, design, and analysis skills. Working knowledge of tooling and manufacturing processes. Experience with medical devices from concept to commercialization.

Understanding of FDA Quality Systems Regulations. CQE certification is desired.

Six Sigma black belt is a plus.

Third-party resumes will not be accepted for this role.

This project will require support onsite in the Massachusetts area.