Senior Quality Engineer

Position: Senior Quality Engineer I
Changing lives. Building Careers.

Joining us is a chance to do important work that creates change and shapes the future of healthcare. Thinking differently is what we do best. To us, change equals opportunity. Every day, our colleagues are challenging what's possible and making headway to innovate new treatment pathways to advance patient outcomes and set new standards of care.

SUMMARY

The Senior Quality Engineer I will provide support for QC Laboratories and material controls at the Braintree site. This individual will provide ongoing Environmental Monitoring Performance Qualification (EMPQ) execution, laboratory readiness activities, and material control oversight supporting the Boston-to-Braintree facility transfer. The Senior Quality Engineer I is responsible for ensuring the manufacture of safe, compliant, and high-quality medical devices by maintaining effective quality systems, supporting manufacturing and engineering operations, and driving continuous quality improvement.

They plan and execute of their duties in compliance with site and enterprise procedures, corporate policies, U.S. Food and Drug Administration regulations, Good Manufacturing Practices (GMP), ISO 9001, ISO 13485, EU MDR, the Canadian Medical Device Regulations (CMDR), and other applicable regulatory agencies. This position operates with the independence, technical depth, and leadership responsibility commensurate with that expected of a senior engineer.

This position will report directly to the QC Manager and is primarily geared towards supporting Quality Control Operations, encompassing Inspection, Microbiology, and Analytical laboratories along with the QA Record Review and Product Release function.

RESPONSIBILITIES

* Ensure compliance with FDA QSR, ISO 13485, ISO 9001, MDR, CMDR, and internal quality system procedures.

* Review, approve, and support quality records including nonconformances, investigations, CAPAs, change controls, validations, and risk documentation.

* Provide quality engineering support to manufacturing operations, including inspections and data analysis.

* Participate in internal and external audits including FDA inspections and ISO surveillance audits.

* Apply statistical and risk-based tools such as SPC, FMEA, and sampling plans.

* Support complaint investigations, KPI monitoring, and SPC trending to drive product and process improvements.

* Collaborate cross-functionally with Manufacturing, Engineering, Regulatory, and Supply Chain.

* Support Quality Management Reviews and performance metrics.

* Lead complex investigations, CAPAs, and cross-functional quality initiatives.

* Serve as subject matter expert for assigned products, processes, or quality systems.

* Approve high-impact validations, change controls, and risk documentation.

* Drive continuous improvement initiatives using Lean, Six Sigma, and advanced statistical methods.

* Provide guidance and mentoring to junior Quality Engineers.

DESIRED MINIMUM QUALIFICATIONS

* A minimum of a bachelor's degree in engineering, science or a related discipline is required

* A bachelor's degree with a minimum of 5+ years of Quality experience or equivalent education and years of experience OR a master's degree with 3+ years of Quality experience or equivalent education and years of experience

* Previous Quality experience in a GMP medical device or pharmaceutical manufacturing environment is required.

* Strong understanding of FDA QSR, ISO 13485, ISO 9001, MDR, CMDR

* Previous experience supporting Environmental Monitoring Performance Qualification (EMPQ) is strongly preferred

* Demonstrates excellent organizational, communication, and project management skills

* Proficient with the MS Office Suite, and statistical software.

* Must be able to work independently with minimal supervision.

* Able to prioritize projects to meet organizational goals and objectives

* ASQ CQE and Lean Six Sigma certifications are a plus

Salary Pay Range:

$81,650.00 - $ USD Salary

Our salary ranges are determined by role, level, and location. Individual pay is determined by several factors including job-related skills, experience, and relevant education or training. In addition to base pay, employees…