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Senior Quality Engineer

4 months ago

Chelmsford, United States Medix™ Full time

The Sr. Quality Engineer will be responsible for cross-functional quality assurance, quality management/compliance, quality control, and activities associated with all products and processes, with a focus on manufacturing activities. In support of Corporate Quality Objectives, the incumbent will lead, manage, and drive improvement in five main areas of the Quality Management System, including CAPA & Nonconformance (NC) Processes; Incoming Inspection Improvements; Perpetual Audit readiness; Product Complaints identified as manufacturing related; and Quality Improvement efforts related to Global or Local initiatives, such as Cost Improvement Projects. Additionally, the Sr. Quality Engineer will support Operations, Engineering, R&D, and Post Market Surveillance team activities to ensure that product quality and services are achieved and maintained.

Principal Responsibilities:

  • Nonconformance (NC) and CAPA Processing: Lead quality activities such as inspection methods, NC containment, correction, closure, and CAPAs; drive improvement through analysis of trend data.
  • Support Incoming & In-Process Inspection Teams: Assist inspection teams in maintaining quality standards.
  • Prepare QSRB and QMR Slides: Create quality system review board and quality management review slides as needed.
  • Field Corrective Actions: Support value stream investigations required for field corrective actions, including risk evaluation.
  • Internal Audits and Supplier Corrective Actions: Conduct internal audits and support supplier corrective actions as necessary.
  • Quality & Cost Improvement Projects: Lead and participate in short-term projects focused on product or process improvements.
  • Production & Process Controls: Review, change, and approve manufacturing procedures, test method validations, quality inspection plans, and process run sheets.
  • Auditing: Perform routine internal and process-related audits. Participate in vendor audits if necessary. Support the back room during regulatory and notified body audits.
  • Documentation Control: Perform change controls (ADC/ECOs) as required.
  • Training: Conduct QA training certifications for new production operators as needed.
  • New Product Development: Support engineering with quality planning, risk evaluation, and validation.
  • Additional QA Tasks: Perform any additional QA tasks as assigned by the QA Manager or Plant Manager.
  • Compliance: Maintain compliance with global and local procedures and policies.
  • Direct Contact with Implantable Device: This position requires direct contact with an implantable device.


Education / Experience Requirements:

  • Minimum 4-year degree in an Engineering discipline (Mechanical, Biomedical, Plastics, Industrial, etc.).
  • ASQ Certified Quality Engineer or Certified Quality Auditor preferred.
  • 3-5 years of experience in Quality and/or related Manufacturing/Engineering roles in a manufacturing setting, with skills in:
  • CAPA, Nonconformance, and MRB lead or management roles.
  • Planning, controlling, and assuring product and process quality.
  • ISO 13485 regulation knowledge and experience with MDSAP.
  • Medical Device Complaint Handling.
  • Quality System management and deployment experience.
  • Risk management.
  • Problem-solving and quality improvement, including quantitative methods.
  • Design Controls.
  • Validations (product and process IQ/OQ/PQ).
  • Supplier Quality Engineering (e.g., Supplier Audits, Inspection Techniques).


Specialized Skills / Other Requirements:

  • Experience with MDSAP (backroom/front room/Subject Matter Expert); Supplier Audits; Internal Audits; Calibration; QA and Incoming Inspection.
  • Knowledgeable of ISO 13485, ISO 14971, and FDA QSR requirements.
  • Proficiency with Microsoft Word, Excel, and PowerPoint.
  • Working knowledge and/or experience with SAP and AGILE strongly preferred.
  • Good listening, verbal, and written communication skills.
  • Excellent interpersonal skills with a demonstrated ability to work in a team environment.
  • Ability to prioritize and adapt to shifting priorities.
  • Ability to work independently with limited supervision.