Senior Quality Engineer Job at ACE Partners, Boston, MA

S0xMNWxTQzJGdWVldHVLN2tVcVNZQ1hhVHc9PQ==
  • ACE Partners
  • Boston, MA

Job Description

Quality Engineer – Medical Device Manufacturing $110k - $130k

US Citizens or Green card Holders

Our client is seeking an experienced Quality Engineer to join their team and support Manufacturing Engineering and Production Sustaining efforts within a fast-paced medical device environment. In this collaborative role, you'll work closely with Operations, R&D, and other departments to ensure full compliance with the Quality Management System (QMS).

Are you an experienced Quality Engineer who thrives in Operations, particularly in Design Transfer, daily manufacturing challenges, yield improvement, and scale-up projects? We want to hear from you!

Key Responsibilities:

  • Oversee quality system implementation within manufacturing processes.
  • Provide Design Assurance Engineering support during Product Development or post-market changes.
  • Collaborate cross-functionally to drive continuous process improvements using Quality Systems.
  • Ensure product specifications are met and documentation is complete.
  • Lead verification and validation activities, including protocol/report development and test method validation.
  • Lead risk management activities, including hazard analysis and FMEA.
  • Build and maintain strong relationships with internal teams and suppliers.
  • Participate in product development, design reviews, and change control.
  • Conduct risk analysis on new designs and processes.
  • Support calibration systems, equipment qualification, and preventive maintenance.
  • Assist with raw material/component inspections and non-conformance investigations.
  • Ensure supplier compliance with regulatory standards.
  • Support production control, test method validations, and Gauge R&R.
  • Conduct internal audits and support CAPA processes.
  • Participate in third-party audits and inspections.
  • Assist with management reviews and provide necessary reports.

Qualifications:

  • Bachelor’s degree in Engineering or related field.
  • 5+ years of experience as a Quality Engineer in medical device manufacturing.
  • Proven experience in design transfer, yield improvement, and scale-up projects.
  • Proficient in writing protocols, evaluating testing results, and conducting product/process validation.
  • Strong understanding of QMS and regulatory compliance (domestic/international).
  • Excellent communication skills and the ability to collaborate across teams.
  • In-depth knowledge of manufacturing quality control and process improvement.

Job Tags

Similar Jobs

General Dynamics Bath Iron Works

Entry-Level Electrician: Shipyard Wiring & Installations Job at General Dynamics Bath Iron Works

 ...Electrician (Grade 1-3). This role involves a variety of tasks including fabrication, layout, installation, and maintenance across the shipyard. Applicants should possess experience with tools and basic knowledge of blueprint reading. This full-time position offers a pay... 

Samuelson Cabinets

Custom Cabinet Installer Job at Samuelson Cabinets

 ...Job Title: Custom Cabinet Installer Job Summary: We are seeking a skilled and detail-oriented Custom Cabinet Installer to join our team. The ideal candidate will have experience in installing custom cabinetry, a keen eye for detail, and a commitment to delivering... 

American Career College

Campus Director, Academic Education - Physician Assistant Job at American Career College

Job Description At West Coast University, we share apassion for students and transforming healthcare education!As a member for a certified Great Place to Work, you will join a collaborative, student-centric culture valuing academic integrity, mutual respect, student...

Home Depot

Corporate Security Officer (Full Time, 2nd Shift) Job at Home Depot

 ...Job Opportunity At The Home Depot With a career at The Home Depot, you can be yourself and also be part of something bigger. Position Purpose: Monitor Pennant Park security and assist Home Depot associates with security and safety related issues. The schedule for... 

Orangeburg County Schools

Sports Medicine Teacher Lake Marion Technology Center Job at Orangeburg County Schools

 ...Description: 2020-2021 Sports Medicine Teacher Job Summary: To provide appropriate...  .... Must be certified in South Carolina in Health Science or a related field or any high...  ...Application Procedure: Apply Online Selection Procedure: Attachment...